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The arthroscope and accessories are intended to be used by a licensed physician, for the purpose of joint arthroscopic procedures.

ADI 9000/9001 arthroscope and accessories.

The provided text is a 510(k) clearance letter from the FDA for an arthroscope and accessories. It does not contain any information about acceptance criteria, device performance, a study, or details about ground truth, sample sizes, or expert adjudication related to performance metrics.

The letter merely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, GMP compliance, and labeling, but not clinical or performance study results.

Therefore, I cannot provide the requested information.

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