(36 days)
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate.
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The technology, design, manufacturing, and materials are substantially equivalent to those of other handpieces on the market, including that of the current 430 series handpiece.
This 510(k) summary for the STAR DENTAL HIGH SPEED HANDPIECE 9600719 does not contain the information necessary to address your request.
The provided document is a summary for a dental handpiece, which is a physical device used for drilling. Your request, however, is structured around the evaluation of a computational device or algorithm that would produce performance metrics like sensitivity, specificity, or F1-score, and would involve concepts like acceptance criteria, ground truth, and expert adjudication for a "study that proves the device meets the acceptance criteria."
Here's why the provided information is insufficient for each point of your request:
- Table of acceptance criteria and reported device performance: This document describes a physical dental tool. Acceptance criteria for such a device would typically relate to mechanical properties, durability, speed, torque, vibration, noise, and sterilization compatibility, rather than diagnostic performance metrics (e sensitivity, specificity, accuracy) that an AI or computational device would have. No such performance metrics are provided.
- Sample size for the test set and data provenance: Not applicable. There is no "test set" in the context of diagnostic data for this physical device.
- Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth, in the context of diagnostic algorithms, refers to the definitive correct answer for a given case. This concept doesn't apply to a dental handpiece in the way you've defined it.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study compares human reader performance (with and without aid) on diagnostic tasks. A dental handpiece is a tool, not a diagnostic aid.
- Standalone (algorithm only) performance: Not applicable. There is no algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. There is no training set for a machine learning model for this device.
- How ground truth for the training set was established: Not applicable.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device based on "intended use, technology, design, manufacturing, and materials." This is a regulatory pathway for physical medical devices and does not involve the kind of performance studies or data analysis that would apply to AI or diagnostic software.
§ 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.