(70 days)
The PAR-4HEX/4HX series handpiece is for use by authorized persons in the practice of the dentistry.
TWIN POWER TURBINE 4 H is a dental handpiece. Through the tube connected to a dental unit, the handpiece of this device receives the air for high speed turbine, the cooling water for cutting treatment through pouring holes and light for illumination source. The PAR-4HEX/4HX series includes ten types of models as is shown below at Table-1, and they are be able to be connected to the coupling of the other manufacturers than J.MORITA.
This 510(k) summary (K061701) describes a dental handpiece, the J. Morita USA Inc.'s TWIN POWER TURBINE 4H (PAR-4HEX/4HX series). The submission claims substantial equivalence to a previously cleared device (K043498), rather than providing a new study with acceptance criteria and performance data. Therefore, many of the requested details about a new study are not present in the provided text.
Here is the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance for a new study are provided in this 510(k) submission. The submission asserts substantial equivalence based on similar intended uses, technological characteristics, and operating principles to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No new study with distinct acceptance criteria presented) | Not applicable (No new study data presented for performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a new study with a test set.
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)
Not applicable. Ground truth establishment for a test set is not mentioned as part of this substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods for a test set are not mentioned as part of this substantial equivalence claim.
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
Not applicable. This device is a dental handpiece (a physical tool), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental handpiece (a physical tool), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth is not relevant for demonstrating the safety and effectiveness of a dental handpiece through a substantial equivalence claim. The equivalence is based on physical and operational characteristics compared to an existing device.
8. The sample size for the training set
Not applicable. This device is a dental handpiece and does not involve AI/machine learning, thus no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, 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.