ID: Lorem ipsum dolor sit amet, consectetur adipiscing elit.
Vestibulum ante ipsum1.0.2The clinical evaluation shall be thorough and objective, and take into account both favorable and unfavorable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
The clinical evaluation will take into account the device under evaluation, equivalent or similar devices (as needed), and the state of the art. Clinical data will be gathered from real world data, generated through clinical investigations (if relevant), captured from the scientific literature, or procured through other relevant sources.
The clinical data will be appraised if needed and analyzed in order to reach conclusions regarding the safety and clinical performance of the device including its clinical benefits.
The following regulatory standards or guidance documents are considered relevant to this clinical evaluation and may be covered in full or used to provide input regarding strategy and conclusions.
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According to EU MDR 2017/745, this device is classified as a Class I device.
A clinical benefit is defined as the positive impact of a device on the health of an individual, expressed in the terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.
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Clinical claims relate to clinical performance or safety of the device and should be supported by appropriate data. All clinical claims related to clinical performance and safety are included below.
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The clinical evaluation shall provide data that should describe conformance to the relevant general safety and performance requirements (GSPRs). That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. GSPRs are described below along with acceptance criteria for determining conformance.
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Any additional information including warnings, precautions, and any applicable labels can be found in the Instructions for Use.
A valid clinical association is understood as the extent to which the device's output (e.g. concept, conclusion, calculations) based on the inputs and algorithms selected, is associated with the targeted physiological state or clinical condition. This association should be well founded or clinically accepted (e.g. existence of a scientific framework or sufficient level of evidence). The valid clinical association of a device should demonstrate that it corresponds to the clinical situation, condition, indication or parameter defined in the intended purpose of the device.
It should be noted that the Valid Clinical Association may not always be readily established. Thus, the clinical performance of the device can serve as an additional valid clinical association from a clinical perspective for the specific intended purpose.
The valid clinical association can be considered the following:
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Technical performance is the demonstration of the device's ability to accurately, reliably and precisely generate the intended output from the input data.
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Clinical performance is the demonstration of the device's ability to yield clinically relevant output in accordance with the intended purpose.
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The clinical evaluation will be conducted according to the clinical evaluation plan and SOP Clinical Evaluation. The clinical evaluation will include the processes in order to gather, appraise and evaluate data so that there is sufficient clinical evidence to support the performance and safety of the device. These processes can include but are not limited to:
A systematic review of the literature as well as a review of clinical trial databases and vigilance databases shall be performed in order to gather adequate clinical data on the device under evaluation, the equivalent device (as needed), and the state of the art. The following sections provide an overview on how this will be performed.
Sufficient clinical evidence should be taken to mean that the available clinical data are sufficient in amount and quality to allow a qualified assessment of whether the device achieves its intended clinical benefit(s) and safety when used as intended.
The clinical development plan outlines progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations and a PMCF.
Clinical evidence generation can occur through exploration of scientific literature and device equivalency. All activities must be completed for each development stage prior to entering into the next development stage unless a justification is provided. Optional steps are performed as needed.
The device was developed considering the usability and human factors engineering principles outlined in IEC 62366. Formative (as needed) and summative testing were performed according to the Usability Evaluation Protocol and the results were captured in the Usability Evaluation Report. The usability testing was performed according to the Usability Evaluation Plan.
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User tests were performed using the device to capture data relating to the user interface, ability of users to perform device tasks, identify any use errors, capture feedback from users, and to ensure all critical tasks were performed correctly. The individual results from the users can be found in the Usability Evaluation Report.
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The device does not come in contact with the human body. As such, no biocompatibility testing is required.
Verification and validation testing were performed according to SOP Integrated Software Development and Software Development and Maintenance Plan. The Software System Test Plan and Software System Test Report confirm that all software requirements have been met.
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For the purpose of this clinical evaluation, the equivalent device chosen to claim equivalence to the device under evaluation is Lorem ipsum dolor sit amet, consectetur.
The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
The following table compares the device under evaluation to the equivalent device.
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A literature search will be performed using a systematic approach for the gathering, appraisal, and review of scientific literature as it relates to the device under evaluation, the equivalent device, and the state of the art.
The following databases will be queried for literature data
Search terms will be determined using the PICO method. PICO search terms include the following:
The search should be sufficiently broad enough to establish benchmarks, determine the state of the art, risks and potential benefits of the device.
Once literature has been gathered, it is to be appraised for relevance. The literature will undergo two reviews to determine if it meets inclusion or exclusion criteria. The first review will occur for the publication Title and Abstract. The second review will occur for the publication full-text.
Inclusion criteria for the publication are as follows:
Exclusion criteria for publications are as follows:
All literature that is excluded based on exclusion or inclusion criteria should be assigned an exclusion code that best represents why it was removed from consideration for clinical evidence. Exclusion codes are found below.
The level of evidence required for demonstrating clinical performance and safety should be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
For this device, according to the level of evidence in the table below (from MDCG 2020-6), clinical data resulting from sources above a "Level 4" are not required due to the low risk of the device. However, the clinical evaluation team will include data from these sources if it is available and relevant. Data from sources of "Level 6" and above is recommended unless otherwise justified.
Once a full-text publication has been identified for being selected for full-text due to inclusion criteria, it will be appraised for relevance. Publications related to the device under evaluation or the equivalent device are considered data pivotal to determining the clinical performance and safety of the device while publications related to the state of the art are considered as supportive data in order to provide benchmark information for the device under evaluation and equivalent device.
The appraisal criteria for the full-text appraisal includes in the following:
The full-text appraisal will be used to determine the weight of the clinical data gathered from the literature search. The lower the score of the appraisal, the higher the weight of the clinical data produced from that literature source. The appraised full-text article table is captured in Appendix D.
The literature search will be performed using keywords according to the PICO search strategy. The keywords used for the literature search are as follows:
Pubmed Search Keywords:
lorem AND ipsum AND dolor
Cochrane Search Keywords:
lorem AND ipsum AND dolor
The following results were gathered from searching the literature databases.
Date of Search: 2023-10-01
Person Performing Search: Jane Doe
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The full list of literature including the appraisal and exclusion codes can be found in the literature search table in Appendix A.
This section describes data related to the performance of the device under evaluation and equivalent device.
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This section describes data related to the safety of the state of the art.
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This section describes data related to the safety of the device under evaluation and equivalent device.
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This section describes data related to the safety of the state of the art.
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Clinical trial registries will be examined for any clinical trials that may provide additional performance and safety information related to the device under evaluation, equivalent device, or the state of the art.
An international clinical trial registry will be probed for clinical trials:
Clinical trials will be searched via clinical trial search keywords. The keywords should attempt to retrieve clinical trials with relevant information regarding the device under evaluation, equivalent device or the state of the art. Clinical trials will be filtered based on inclusion and exclusion criteria.
Inclusion criteria for clinical trials are:
Exclusion criteria for clinical trials are:
Clinical trials identified as relevant will be summarized below and considered for clinical evidence.
Search keywords for clinical trial databases are determined based on the same PICO criteria as used for the literature search terms. The search keywords used for clinical trial database search are as follows:
lorem AND ipsum AND dolor
The following results were gathered from the clinical trials database.
Date of Search: 2023-10-01
Person Performing Search: Jane Doe
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The full list of clinical trials can be found in the clinical trials search table in Appendix B.
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Post-market data is considered for the clinical evaluation. The device has a post-market surveillance system in place according to SOP Post-Market Surveillance. In addition to any available data from post-market surveillance or complaints, data will be gathered from international vigilance databases on the device under evaluation, equivalent device and state of the art. As this will be the first introduction of the device onto the market the post-market data will be limited. A post-market clinical follow-up plan has been established according to SOP Post-Market Surveillance and SOP Clinical Evaluation.
Multiple international vigilance databases will be investigated for data relating to the safety of the device under evaluation, equivalent device, and state of the art. The following databases will be searched for any relevant vigilance data:
Vigilance data collected during the search that is related to the device under evaluation, equivalent device, or the state of the art will be reviewed to identify any risks not previously identified in the risk assessment. Additionally, the risk profile of the generally accepted state of the art will be determined to be compared against the risk profile of the device under evaluation.
Vigilance databases were searched using keywords related to the device under evaluation, equivalent device, and the state of the art. The following keywords were used as search terms for the international vigilance databases.
lorem AND ipsum AND dolor
The following results were gathered from the vigilance database search.
Date of Search: 2023-10-01
Person Performing Search: Jane Doe
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Complaints data is captured according to SOP Feedback and Complaints Management. Because the device is new to the market, there are no complaints data available at this time.
Corrective and preventive actions are captured according to SOP Corrective and Preventive Actions (CAPAs). There are currently no open CAPAs related to the device.
No pre-market clinical investigations were performed for the device under evaluation.
Clinical benefits were identified and substantiated using the clinical data gathered from the literature search, clinical trials search, vigilance search as well as any relevant information held internally by the manufacturer.
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The clinical claims were substantiated using the clinical data gathered from the literature search, clinical trials search, vigilance search as well as any relevant information held internally by the manufacturer.
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The data presented in this clinical evaluation report demonstrate compliance to GSPR 1, GSPR 2, GSPR 6, and GSPR 8. The device has been shown to achieve its intended purpose and has an acceptable benefit risk ratio.
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The clinical data analyzed in this clinical evaluation report provides support for the following:
The clinical evaluation has been performed according to the clinical evaluation plan and SOP Clinical Evaluation. The clinical evaluation has been performed by a qualified clinical evaluation team.
The date of the next clinical evaluation will be 5 years from the date of this clinical evaluation report for Class I devices and 2 years for Class IIa devices. The clinical evaluation will be updated as needed based on the results of post-market surveillance and any new clinical data that becomes available.
The clinical evaluation team shall have the required expertise and experience to appropriately perform the clinical evaluation as described in SOP Clinical Evaluation. The members of the clinical evaluation team include the following people:
Jane Doe, PhD, Clinical Scientist; John Smith, MD, Medical Advisor
Members of the clinical evaluation team declare that there are no potential conflicts of interest that may impact their objectivity during the clinical evaluation. They confirm no financial interests or professional relationships that could compromise the impartiality of the evaluation. The team commits to conducting the clinical evaluation with integrity, adhering to regulatory guidelines and confirming their declaration of interest by signing this document.
Curriculum vitae's for the clinical evaluation team are available upon request.
Full-text copies of relevant publications are available upon request.
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