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The Seiler colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.

A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose and examine abnormalities of the vagina and cervix and select areas for biopsy. This generic type of device may include a light source, cables, and components parts.

The Model 935 colposcope with a 300mm objective lens has 3-magnifications, 3x, 7x, and 17x. The optics are mounted on a column and roll-around base for easy access to the areas of examination.

The Model 955 colposcope with a 300mm objective lens has 5-magnification, 3x, 4x, 7x, 11x, and 17x. The optics are mounted on swing-arms on a roll-around base.

The Model 985 colposcope with a 300mm lens also has 5-magnifications. 3x. 4x. 7x. 11x. and T Model 955, the optics are mounted on a swing-arm on a roll-around base, however the optics and arm can be swung into place from a stored position above and to the side of the user.

Most predicate colposcopes have an optical pod with various magnifications, a power supply, usually halogen, and a delivery system i.e. floor stand and base. We offer similar features, however our power unit has 2 modes of illumination which allows for the spare illumination to be accessed with a flip of a switch.

I am sorry, but the provided text does not contain the detailed information needed to describe acceptance criteria and a study proving device performance in the manner requested. The document is a 510(k) summary for a colposcope, focusing on establishing substantial equivalence to predicate devices and detailing the device's intended use, indications for use, and a general summary of electrical, optical, and safety testing.

Specifically, the document states:

• "ALL ELECTRICAL TESTING INCLUDING ELECTRICAL SAFETY, EMC TESTING, THERMAL TESTING, OPTICAL QUALITY TESTING AND TUV CERTIFICATION WERE PERFORMED BY CERTIFIED TESTING LABORATORIES, THE PRODUCT PASSED ALL TESTS."
• "COPIES OF THE TEST RESULTS ARE LOCATED IN SECTIONS D. AND E. IN OUR SUBMISSION."

However, it does not provide:

1. A table of specific acceptance criteria (e.g., numerical thresholds for optical quality, electrical safety) or the reported device performance against those criteria.
2. Details about sample sizes used for testing, data provenance, or information about specific studies.
3. Information regarding expert involvement for ground truth, adjudication methods, or multi-reader, multi-case studies.
4. Information about standalone algorithm performance, ground truth types used, or training set details, as the device described is a physical instrument (a colposcope), not an AI algorithm.

Therefore, I cannot fulfill the request for information organized into the specified table format or answer the detailed questions about study methodology for AI devices. The document confirms that testing was done and passed, but the specifics are not included in this summary.

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