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A dental contra-angle handpiece that attaching a vertical reciprocating dental strips intended to be used in interproximal reduction of teeth; And it is part of orthodontic treatment of finishing interdental and subgingival area, finishing cavity edges, removing the dentin of teeth adjacent, removing subgingival plague and tripping. The device incorporates a small micro motor normally driven by compressed air; This is a reusable device.

The OK handpiece is a reciprocating contra-angle handpiece that is used in connection with an air motor. The rotational force of the air motor is transmitted to the handpiece head through the shaft of the handpiece body, and the rotational force of the shaft is converted into vertical reciprocating motion in the head. The OK handpiece is a reprocessing medical device. Users must steam sterilize before each use, and clean thoroughly after use. The OK handpiece does not have water/air spray and light supply. Therefore, the air motor connection of the handpiece is designed to comply with the coupling size of TYPE 1 of ISO 3964. For the strip connecting to the OK handpiece, you must use Orthok-Strips and OK Proxofile of Jaintek Co., Ltd.

The provided text (K221814) describes the 510(k) premarket notification for the "OK Handpiece," a dental contra-angle handpiece. This device is classified as a Class I medical device (21 CFR 872.4200) and is cleared based on substantial equivalence to predicate devices, not requiring extensive clinical trials typically associated with novel or higher-risk devices.

Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on non-clinical performance testing and compliance with relevant standards, rather than complex clinical studies involving human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the OK Handpiece (K221814)

This device, a dental handpiece, demonstrates substantial equivalence through non-clinical bench testing and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on a Non-Clinical Device)

Given that this is a Class I dental handpiece, the "study" is primarily a series of non-clinical bench tests and adherence to recognized international standards. The device is not software-based or image-analyzing AI, so many of the requested items related to AI/MRMC studies are not applicable.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical data for a handpiece. Performance was verified on the device itself against standard requirements. For physical testing (e.g., bur extraction force, durability), usually a representative sample of manufactured devices would be tested to demonstrate consistency with design specifications. The document implies that "the proposed device" met the specifications, suggesting testing was performed on actual devices.
• Data Provenance: The tests were non-clinical bench tests conducted to "verify that the proposed device met all design specifications" and demonstrated compliance with ISO standards. There is no mention of country of origin for test data, as it's performed to international standards. It's an engineering validation, not data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable as this is a physical device undergoing non-clinical testing against engineering and material standards. "Ground truth" is established by the specifications of the standards themselves (e.g., ISO 3964 requires a specific coupling dimension, ISO 10993 outlines biocompatibility criteria). Expertise would lie with engineers and biocompatibility specialists performing and interpreting the tests, ensuring compliance with the specified standards.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is measured objectively against quantitative and qualitative criteria defined by the standards (e.g., a dimension either meets ISO 3964 or it doesn't; a material either passes cytotoxicity or it doesn't). There is no "adjudication" in the sense of expert consensus on an interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging devices, especially those involving AI, where human readers interpret medical images. The OK Handpiece is a mechanical dental tool, not an imaging or diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No, a standalone algorithm performance study was not done. This device does not incorporate any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on engineering specifications and compliance with established international consensus standards (e.g., ISO for mechanical properties, ISO for biocompatibility, ISO/ANSI/AAMI for sterilization). For example, the "ground truth" for motor coupling is adherence to the dimensions specified in ISO 3964.

8. The Sample Size for the Training Set:

• Not applicable. This device is a mechanical medical instrument. It does not utilize machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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