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FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.

Video Laparoscope EL-R740M30 is comprised of a rigid insertion portion, cable portion, and scope connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light guide fiber bundles are connected to the scope connector through the laparoscope.

The provided text describes the 510(k) summary for the FUJIFILM Video Laparoscope Model EL-R740M30. However, it does not include the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria for AI/ML-based medical devices.

The document discusses:

• Device Identification: FUJIFILM Video Laparoscope Model EL-R740M30
• Intended Use: Minimally invasive observation, diagnosis, and treatment in general abdominal, gynecologic, and thoracic areas.
• Device Description: Rigid insertion portion, cable portion, scope connector, optical system, CCD image sensor, electrical circuits.
• Predicate Device: FUJIFILM Video Laparoscope EL-R740M (K202130)
• Technological Characteristics Comparison: Highlights differences like viewing direction (0 degrees for predicate, 30 degrees for subject device) and presence of an adjustment ring.
• Performance Data: Mentions conformity to various electrical safety, biocompatibility, endoscope-specific, cleaning/sterilization, and software standards (e.g., ANSI/AAMI ES60601-1, ISO 10993, ISO 8600-1, ANSI/AAMI/IEC 62304). It also mentions cybersecurity controls.

Crucially, this document pertains to a traditional medical device (a video laparoscope) and not an AI/ML-based medical device. Therefore, it does not include information on acceptance criteria for AI performance, sample sizes for AI test sets, expert adjudication, MRMC studies, or standalone AI performance.

The "Performance Data" section describes compliance with electrical and biocompatibility standards, and validation of reprocessing protocols, which are typical for hardware medical devices, not AI/ML algorithm validation. There is no mention of an algorithm or AI component in the device.

Therefore, I cannot provide the requested information based on the provided text.

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