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The Sirona Dental Systems Implant Handpieces are intended for use during endodontic treatment, dental implant surgeries and general dentistry. The Sirona 20:1/80:1 Implant Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).

The Sirona Implant Handpieces are handpieces with transmission ratios of 80:1 and 20:1. They can be driven by torque adjustable electrical motors for surgery treatments and air motors for general dental treatment. The Implant handpieces are attached to their drives via ISO 3964 coupling. A saline irrigation system for surgery treatment is integral to the Implant Handpieces. The head clamp accepts WB instruments complying with ISO 1797-1.

This document describes a 510(k) premarket notification for Sirona Dental Systems Implant Handpieces, which is a dental device, not an AI/ML powered medical device. Therefore, a significant portion of the requested information, particularly regarding acceptance criteria, study details, human reader performance comparisons, and ground truth establishment common in AI/ML device submissions, is not applicable or available in this type of submission.

However, I can extract and state the information that is relevant to the nature of this submission:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission for a dental handpiece, the acceptance criteria typically revolve around meeting industrial standards for performance, safety, and mechanical integrity, rather than diagnostic accuracy metrics. The "device performance" in this context refers to its ability to function as intended and meet these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of device submission. A dental handpiece is a mechanical tool; its "performance" is evaluated through engineering tests, compliance with standards, and comparison to predicate devices, not through studies on a test set of data like an AI/ML diagnostic system. There's no "data" in the sense of medical images or patient records.

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)

This information is not applicable. "Ground truth" in the context of an AI/ML diagnostic device refers to the definitively correct diagnosis or finding to which the AI's output is compared. For a dental handpiece, there is no such "ground truth" to establish through expert consensus as it's a tool, not a diagnostic system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are used in studies where multiple experts provide opinions on data to establish a ground truth or resolve discrepancies, typically for diagnostic or prognostic AI/ML systems. This is not relevant for a mechanical medical device like a dental handpiece.

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

This information is not applicable. MRMC studies are specific to evaluating the clinical utility and effectiveness of AI systems in assisting human readers (e.g., radiologists interpreting images). This device is a surgical/procedural tool, not an AI-powered diagnostic aid. Therefore, no such study would be performed for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a mechanical tool, not an algorithm, so the concept of "standalone performance" for an algorithm is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. As explained in point 3, there is no "ground truth" in the diagnostic sense for a dental handpiece. Its performance is verified against engineering specifications, safety standards, and functional requirements.

8. The sample size for the training set

This information is not applicable. A dental handpiece is a manufactured product; it does not involve machine learning, and therefore there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set (see point 8), there's no ground truth to establish for it.

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