(129 days)
Intended to magnify the view of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Not Found
The provided document is an FDA 510(k) clearance letter for the Ecleris Microstar colposcope (K100595). This document primarily focuses on establishing substantial equivalence for a physical medical device (colposcope) and does not contain the kind of information requested about acceptance criteria and a study proving a device meets them, especially in the context of an AI/algorithm-based device.
Therefore, I cannot extract the requested information from the provided text. The document does not discuss:
- Acceptance criteria table and reported device performance.
- Sample size for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect size of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes, expert consensus).
- Sample size for training set or how its ground truth was established.
This document is concerned with the regulatory clearance of a physical medical device (a colposcope), not AI or algorithmic performance.
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.