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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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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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