(21 days)
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.
a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm. A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.
The provided text is an FDA 510(k) clearance letter for a dental device, the "PROPHY-MATE Motor Handpiece." This type of document is a regulatory approval, not a scientific study report. As such, it does not contain any of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or specific study methodologies.
The letter explicitly states that the device is deemed "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA's decision is based on a comparison to existing, legally marketed predicate devices, rather than requiring new clinical trials or performance studies with acceptance criteria as one would find for a novel device.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why this information is missing:
- Acceptance Criteria and Reported Device Performance: Not included. The letter is about regulatory clearance based on substantial equivalence, not a detailed performance report.
- Sample Size and Data Provenance: Not applicable to this type of regulatory submission. The substantial equivalence pathway typically relies on existing knowledge and comparison to predicate devices, not new sample-based studies.
- Number of Experts and Qualifications: Not mentioned. Expert review in this context would be part of the FDA's internal process for assessing the 510(k) submission against the predicate device, not for establishing ground truth in a clinical study.
- Adjudication Method: Not applicable. There's no clinical trial data with adjudication described.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned and highly unlikely for a device seeking 510(k) clearance through substantial equivalence for a basic dental handpiece.
- Standalone (algorithm only) Performance: Not applicable, as this is a mechanical dental handpiece, not an AI or algorithm-driven device.
- Type of Ground Truth Used: Not applicable. There's no clinical study described that would require a ground truth.
- Sample Size for Training Set: Not applicable, as there's no machine learning model or algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
§ 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.