(114 days)
The Interproximal Reduction System is intended for use as a method of achieving interproximal reduction of teeth.
The Interproximal Reduction System handpiece includes an air-driven low-speed motor and a contra-angle integrated with the head. It is used with the abrasive strips for interproximal reduction/stripping, polishing, or preparation of tooth for placement of orthodontic appliances (aligners, brackets, retainers, etc.)
This 510(k) summary describes an Interproximal Reduction System, which is a dental handpiece and accessories. The filing states that "All of the components found in the Interproximal Reduction System have been used in legally marketed devices and were found safe for dental use. We believe that the prior use of the components in legally marketed predicate devices and test results support the safety and effectiveness of the Interproximal Reduction System for the indicated uses."
Based on the provided text, a detailed study proving the device meets specific acceptance criteria is not included. The submission relies on the substantial equivalence to predicate devices, asserting that the components have been previously deemed safe and effective in other legally marketed devices.
Therefore, for your request, I will indicate that the information is not provided as it pertains to specific acceptance criteria and a study demonstrating their achievement for this particular device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: Not provided in the document. The filing relies on the established safety and effectiveness of individual components in predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable, as no specific test set requiring expert ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as no specific test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: Not performed or described. This device is a dental handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not performed or described. This device is a mechanical handpiece, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, as no specific test requiring ground truth is described. The basis for safety and effectiveness is substantial equivalence to predicate devices.
8. The sample size for the training set
- Sample Size: Not applicable, as this is a mechanical device, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable as there is no training set for this device.
§ 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.