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An electrically-powered, low-speed (<5000 RPM) demal handpiece as defined in C.F.R. 872.4200 intended for use with a disposable contra-angle device which a suitable rubber cup, or similar for the purpose of cleaning and/or polishing teeth with an appropriate mixture of pumice and water, prophylaxis paste, or the like.

The MODEL MS-1 HANDPIECE is an electrically-powered, lowspeed handpiece intended for use with a contra-angle in which a rubber cup or bristle brush is inserted for the purpose of cleaning and/or polishing teeth using an appropriate prophylaxis paste, pumice/water mixture, or the like.

This document describes a 510(k) submission for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML-specific metrics cannot be extracted from the provided text.

The document primarily focuses on:

• Device Identification: Trade Name (MODEL MS-1 HANDPIECE), Common Name (Low-Speed Prophy Handpiece), Classification Name (Dental Handpiece).
• Intended Use: An electrically-powered, low-speed handpiece for cleaning and polishing teeth with a contra-angle, rubber cup/bristle brush, and prophylaxis paste.
• Equivalence: Listing of predicate devices, implying a substantial equivalence pathway for clearance rather than a novel technology requiring extensive performance studies.
• Regulatory Clearance: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices.

There is no mention of:

• Acceptance criteria in terms of analytical or clinical performance metrics.
• Specific studies proving performance against such criteria.
• Sample sizes, data provenance, ground truth establishment, expert involvement, or AI/ML-specific study designs (like MRMC or standalone performance).

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