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CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Dental Air-Powered Handpiece

The provided text is for a 510(k) premarket notification for a dental air-powered handpiece. This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with proving performance against specific acceptance criteria in a study format typically seen for advanced diagnostic devices or AI algorithms.

Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth definitions) are not applicable or extractable from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion for a 510(k) submission like this is "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states: "The claim of substantial equivalence is based on comparisons of formulations and intended uses of the HPS Dental Air-Powered Handpiece and its claimed predicate." No specific performance data (e.g., rotational speed, torque, vibration levels) or clinical outcomes are provided for the CODENT device or its predicate.

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/available. This document does not detail a study involving test sets of data. It's a review of device design and intended use for substantial equivalence.

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/available. No such ground truth establishment is described for this type of device submission.

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

• Not applicable/available.

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/available. This device is a dental handpiece, not an AI-powered diagnostic device.

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

• Not applicable/available. This is not an algorithm.

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

• Not applicable/available. The "ground truth" for this submission is whether the device's design, materials, and intended use are comparable to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable/available.

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

• Not applicable/available.

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