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K Number
K091065
Device Name
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
Manufacturer
J. MORITA USA, INC.
Date Cleared
2009-10-16

(185 days)

Product Code
EFB
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K944713
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.

Device Description

This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.

AI/ML Overview

The provided text is a 510(k) summary for a dental handpiece (AIR TORX) and does not contain information about studies proving the device meets specific acceptance criteria as it would for a software AI/ML device.

The document states that the device is classified as a non-exempt Class I device and its substantial equivalence is based on similar general intended uses, principles of operation, and technological characteristics to a predicate device (MICRO AIR MOTOR A-25LT, K944713). It explicitly states that "these differences do not raise new questions of safety or effectiveness," which means that extensive new performance studies (like those requiring acceptance criteria, test sets, or ground truth establishment) are generally not required for Class I devices deemed substantially equivalent through this pathway.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods typically associated with proving the performance of novel medical devices, especially AI/ML-based ones.

Specifically, the following requested information is absent from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present. The comparison table is for "Technological characteristics" and primarily states "Similar" for most categories.
  2. Sample size used for the test set and the data provenance: Not applicable/not present. No clinical or performance test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
  4. Adjudication method for the test set: Not applicable/not present.
  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/not present. This device is a mechanical dental handpiece, not an AI system.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
  7. The type of ground truth used: Not applicable/not present.
  8. The sample size for the training set: Not applicable/not present.
  9. How the ground truth for the training set was established: Not applicable/not present.

§ 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.