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The Pristine Arthroscopic Visualization System is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Pristine Arthroscopic Visualization System is indicated for use in arthroscopic procedures performed in the hip, knee and shoulder.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Pristine Arthroscopic Visualization System does not contain any information about the acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The letter is a general regulatory clearance document that states the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: Pristine Arthroscopic Visualization System
• Regulation Number and Name: 21 CFR 888.1100, Arthroscope
• Regulatory Class: Class II
• Product Code: HRX
• Indications for Use: Provides an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy in hip, knee, and shoulder arthroscopic procedures.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, etc.

It does not include details about:

• Any specific acceptance criteria for performance, especially for AI or algorithmic components.
• Results of a study proving the device meets performance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. This type of detailed performance data is typically found in the full 510(k) summary or in test reports submitted as part of the clearance application, which are not included in this FDA clearance letter.

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