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FUJIFILM Video Laparoscope EL-R740M 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-R740M 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 quide fiber bundles are connected to the scope connector through the laparoscope.

This document is a 510(k) summary for the FUJIFILM Video Laparoscope, Model EL-R740M. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity.

The performance data listed refers to:

• Photobiological safety in accordance with IEC 62471:2006.
• Biocompatibility evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017.
• Endoscope specific testing conducted according to ISO 8600-1:2015.

These are standard safety and performance tests for medical devices, but they do not involve clinical performance metrics (like sensitivity/specificity) against a ground truth.

Therefore, for the information requested regarding acceptance criteria and a study proving the device meets it:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table with acceptance criteria for clinical performance (e.g., diagnostic accuracy, sensitivity, specificity) and reported device performance against such criteria. The performance data mentioned are related to safety, biocompatibility, and general endoscope standards.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study involving a test set against a ground truth is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (video laparoscope), not an AI algorithm.

7. The type of ground truth used: Not applicable, as no clinical performance study is detailed.

8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence based on design, intended use, and safety characteristics (photobiological, biocompatibility, and general endoscope standards) compared to a predicate device, rather than clinical performance metrics typically required for AI/diagnostic devices against a specific ground truth.

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