Question

The device performance claimed in ifu.pdf, § Clinical Benefits and Performance Claims does not clearly meet GSPR 15.1 (23.4(c), (e) and (h)) because it is unclear which diagnostic features (e.g., ICD conditions, signs or measures) the reported metrics apply to. Definitions for the tags (e.g., 7GH, 7V9, etc.) and full references for the studies cited (e.g., IDEI_2023, BI_2024, etc.) could not be found in the IFU, so it is unclear how a user will be able to understand the context behind the values and applicability to their decisions. Please clarify and provide updated documentation as necessary.