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For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.

The flexible fiberscopes consist of a flexible insertion part, a control part and an eyepiece for direct view or connection to a video camera.

This document, K980401, describes the premarket notification for "Flexible Fiberscopes and Accessories" by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving a device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study to prove performance cannot be extracted from this document, as such a study was explicitly stated as not performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not specify quantitative acceptance criteria or report performance against such criteria. It states, "No known FDA performance standard exists."

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. The document explicitly states: "Clinical tests performed were not performed."

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. No clinical tests were performed, so no ground truth was established through expert review for a test set.

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

Not applicable. No clinical tests were performed, hence no test set or adjudication method.

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. This is a medical device for direct visualization, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device (fiberscope), not an algorithm.

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

Not applicable. No clinical tests were performed, and thus no ground truth was established in this context. The document relies on design and testing to assure safety and effectiveness rather than clinical ground truth derived from patient data.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device.

Summary of Device Safety and Effectiveness Demonstration:

Instead of a study with acceptance criteria, the document demonstrates substantial equivalence by:

• Technological Characteristics: Stating "There are no significant technological changes or characteristics to the new devices compared to the existing devices" and detailing minor improvements like increased pixels/fibers for higher resolution.
• Intended Use: Consistent with predicate devices.
• Substantial Equivalence Claim: Comparing the device to several pre-enactment and 510(k) cleared flexible fiberscopes from Richard Wolf, Circon, Karl Storz, and Olympus.
• Performance Data: Reporting that the electrodes in combination with the fiberscopes were tested to meet appropriate sections of ANSI/AAMI standard HF18 (on high frequency devices) and IEC601-1/IEC601-2-2. These are engineering performance standards for electrical safety and electromagnetic compatibility, not clinical performance criteria.
• Conclusion: The devices are "designed and tested to assure their safety and effectiveness when used according to the instructions manual," relying on engineering standards and design verification rather than clinical outcomes.

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