Question

Observations

Outcomes for clinical benefit, safety, and performance and acceptance criteria as established based on SotA for similar/alternative devices remains unclear.

For example:

Clinical benefit:

• It is difficult to follow all of the clinical benefits and means of measure and acceptance criteria as provided in §17.4 of the CEP and the Clinical Benefit document
• Discussion of what some of these mean (e.g. Top-1 accuracy), why these were chosen, and how they are relevant to the intended purpose are not found
• Clear traceability and analysis of how acceptance criteria are established based on state-of-the-art (what articles, similar devices, why these were chosen, etc from the SotA document) is not found. The SotA document seems to contain a summary of each article but complete analysis is not found.
• Clinical benefit OZC seems to mention remote care, although §14 of the CEP seems to state that this device will be used by HCPs only in healthcare facilities, therefore, remote use is unclear

Clinical performance:

• There are a significant number of claims which are difficult to follow
• It remains unclear how each is established, which diseases are involved (many say multiple conditions), how it is appropriately based on SotA (traceability to articles/devices as provided in the SotA document). The SotA document seems to contain a summary of each article but complete analysis is not found.
• Justification for why it is relevant, and acceptance criteria (some acceptance criteria seem low) is not found
• It is unclear how/why data was pooled

Clinical safety:

• It is unclear how rates are based on state-of-the-art/similar devices from the literature (no traceability to SotA document). The SotA document seems to contain a summary of each article but complete analysis is not found.
• Further justification of appropriateness/relevance is not found.

Request

Please address all points above.

Please provide clear, specified and relevant clinical benefits, outcomes, and measurable acceptance criteria as based on SotA against which the subject device will be assessed in order to demonstrate compliance with Annex XIV 1 (a), sub-bullet 4 and Article 2 (53) and Annex II. Please provide traceability to relevant SotA articles used along with analysis and justification.

Please provide clear, specified and relevant performance and safety outcomes, and measurable acceptance criteria as based on SotA (with justification and traceability) against which the subject device will be assessed in order to demonstrate compliance with Annex XIV 1 (a), sub-bullet 6 and Annex II. Please provide traceability to relevant SotA articles used along with analysis and justification.