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This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.

The subject device, LAPARO-THORACO VIDEOSCOPE XLTF-VAW is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. The subject device has a different lens cleaning method from the predicate Olympus LAPARO THORACO VIDEOSCOPE LTF-V. For the predicate device, air and water for lens cleaning are supplied through the sbace between the endoscope's insertion and a sheath attached to it. The subject device also uses a sheath but irrigation are performed through the inner channels of the videoscope. The basic structure of the inner channel is substantially equivalent to that of the predicate device, GIF-Q160Z.

The provided text is a 510(k) Summary for the LAPARO-THORACO VIDEOSCOPE XLTF-VAW. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical testing.

Therefore, the requested information cannot be extracted from the given text. A 510(k) typically focuses on comparing the new device's technological characteristics and proposed indications for use to a legally marketed predicate device, rather than providing detailed study results for performance metrics against established acceptance criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance directly addressing those criteria.
• Information on sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies for a performance evaluation.
• Details about a standalone algorithm performance study.
• The type and method of establishing ground truth for any test or training sets, as it describes a device (endoscope), not an AI algorithm requiring such data.

The document indicates that "the XLTF-VAW does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device" when compared to the predicate device. This is the basis of its substantial equivalence claim, not a separate study proving performance against defined acceptance criteria.

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