(818 days)
Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are by a trained professional in the field of general dentistry.
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I am sorry, but the provided text from the FDA letter (K202674 for Medidenta High Speed Handpieces) does not contain the information necessary to describe acceptance criteria and a study proving a device meets acceptance criteria in the way you've outlined.
The document is an FDA 510(k) clearance letter for a dental handpiece, establishing its substantial equivalence to previously marketed devices. It details the regulatory process, product classification, and general controls applicable to the device.
Specifically, it lacks any information regarding:
- Performance metrics (sensitivity, specificity, accuracy, etc.)
- Studies conducted to prove performance
- Acceptance criteria for these metrics
- Sample sizes for test or training sets
- Ground truth establishment methods
- Expert qualifications or adjudication methods
- MRMC studies or human reader improvement with AI assistance (as this is not an AI/software device)
- Standalone algorithm performance (again, not an AI/software device)
This letter is a regulatory document confirming clearance, not a clinical study report or a technical performance specification. Therefore, I cannot generate the requested table and study description based on the provided input.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.