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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.

The CHF-V choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct . The CHF-V choledochoscope is basically identical to the predicate device, CHF Type P10 OES Nephroscope/Cystoscope, in intended use, spacifications, performance. The optical system of the CHF-V Is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The provided document is a 510(k) summary for the OLYMPUS CHF-V CHOLEDOCHO VIDEOSCOPE. It establishes substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics. Therefore, detailed information requested in the prompt's points 1-9 is largely not available in this type of submission.

Here's an analysis based on the provided text for each requested point:

1. A table of acceptance criteria and the reported device performance

• Not Applicable (N/A). This 510(k) submission does not present specific acceptance criteria or performance metrics in a table. It asserts substantial equivalence to a predicate device based on similar intended use and technological characteristics, particularly in comparison to the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084). The document compares specifications in Table 15-2 but does not provide quantitative performance data against predefined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A). The submission does not describe a clinical performance study with a test set. This is a premarket notification asserting substantial equivalence, not a report on a clinical trial or performance evaluation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable (N/A). As no test set from a clinical performance study is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable (N/A). No test set or associated adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable (N/A). This document concerns a video endoscope for direct visualization, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable (N/A). The device is a video endoscope, which is a human-operated medical instrument. There is no "algorithm only" performance that would be applicable to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable (N/A). As there is no described clinical performance study, there's no mention of a ground truth type.

8. The sample size for the training set

• Not Applicable (N/A). This submission is for a medical device (endoscope), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable (N/A). This submission does not involve a training set as it's not a machine learning device.

Summary of the Study (as per the 510(k) submission):

The "study" presented in this document is a substantial equivalence comparison to a legally marketed predicate device, the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084).

• Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this 510(k) is demonstrating that the CHF-V Choledocho Videoscope is substantially equivalent to the predicate device in terms of intended use, specifications, performance, and materials, and that it does not incorporate any significant changes that could affect safety or effectiveness. The device's performance is implicitly accepted by its similarity to the predicate device, which has a history of safe and effective use.
  • Table of (Implied) Acceptance Criteria & Reported Performance (based on comparison to predicate):

• Conclusion: The submission concludes that "When compared to the predicate device, the CHF-V 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." The primary differences highlighted are the Field of View (120° vs 90°), Working Length (380mm vs 330mm), and the Optical System (Color CCD vs. Image guide fiber bundle). These differences are presented without specific performance metrics against a clinical standard, but rather as design differences from the predicate device that are deemed not to raise new questions of safety or effectiveness.

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