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The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement

The dental handpiece attachment "KOMET - OS30" is a drive, in order to enable the mechanical interproximal enamel reduction by means of the oscillating movement of the attached "KOMET - OS Discs". "OS30" is provided with a coupling system according to ISO 3964, allowing the handpiece's attachment onto a corresponding dental motor. The handpiece's gearing elements transmit the motor's rotational movement up to the integrated head gear, where this movement is converted into an oscillating one. The "OS Disc", chucked in the said head gear, oscillates in an angle of 30°, depending on the motor's speed with max. 5.000 oscillations/min.

The provided document is a 510(k) Pre-market Notification for a dental contra-angle handpiece. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a formal study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, a specific study proving device performance, sample sizes, expert involvement, adjudication methods, or MRMC/standalone studies as typically found for AI/imaging device submissions.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Device Performance: This document states "Bench testing results demonstrate substantially equivalence," but does not provide a table of specific acceptance criteria or quantitative performance data. The device is a mechanical contra-angle handpiece, not an AI or diagnostic imaging device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its acceptance is based on demonstrating it functions similarly to existing, cleared devices.

• Sample Size (Test Set) and Data Provenance: Not applicable. Performance testing for this device would likely involve mechanical and functional benchmarks, not a "test set" of patient data.

• Number of Experts and Qualifications: Not applicable. Ground truth for this type of mechanical device is typically established through engineering specifications and functional testing, not expert clinical interpretation.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a mechanical device, not an AI diagnostic tool where human reader performance would be a factor.

• Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.

• Type of Ground Truth: For a dental handpiece, the "ground truth" would be engineering specifications and successful functional operation (e.g., maintaining oscillations, durability, safety parameters). The document implies that this was established through "bench testing results."

• Sample Size for Training Set: Not applicable. This is a manufactured product, not a machine learning model.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information related to performance/equivalence:

1. Acceptance Criteria/Reported Device Performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate devices (Dentsply International: "Interproximal Reduction System", K053368, and A-dec Incorporated: "A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67...", K082827). This implies meeting similar safety and performance envelopes as the predicates.
   • Reported Device Performance: "Bench testing results demonstrate substantially equivalence." The device is described to convert rotational movement into an oscillating movement, with the "OS Disc" oscillating in an angle of 30°, depending on the motor's speed, with max. 5,000 oscillations/min. This performance is consistent with its intended mechanical function and similar to predicate devices.

2. Sample Size (Test Set) and Data Provenance: Not provided/Not applicable given the device type.

3. Number of Experts and Qualifications: Not provided/Not applicable.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No.

6. Standalone Performance Study: No, as it's a mechanical device. Performance was assessed via "bench testing results."

7. Type of Ground Truth: The ground truth for proving substantial equivalence was based on engineering specifications and functional performance verified through "bench testing."

8. Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set Was Established: Not applicable.

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