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The TWISTT.M. (Recioprocating Disposable Prophy Angle) is indicated for teeth cleaning/ polishing.

TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE

This is a 510(k) clearance letter for a medical device called the "Twist Reciprocating Disposable Prophy Angle." This document primarily deals with regulatory approval based on substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of regulatory document.

However, based on the provided text, I can infer the following:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The letter states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This implies that the 'acceptance criteria' were met through a demonstration of substantial equivalence to a legally marketed predicate device, rather than through specific performance metrics outlined in this letter.

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 provided in the document. 510(k) summaries might sometimes contain summaries of performance data, but this specific clearance letter does not.

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 provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

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/provided in the document. The device is a "Reciprocating Disposable Prophy Angle" which is a dental instrument, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided in the document. This device is a physical dental instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. For a physical device like this, performance testing might involve mechanical durability tests, biocompatibility tests, or efficacy studies for teeth cleaning/polishing, but the details of such tests or their 'ground truth' are not in this letter.

8. The sample size for the training set
This information is not provided in the document.

9. How the ground truth for the training set was established
This information is not provided in the document.

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