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The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

This device is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water sprav is generated. This spray can be directed on the tooth surface to clean and polish the tooth.

The provided document is a 510(k) summary for the EasyProphy Series Air Polish Devices. It does not contain information about acceptance criteria for a device performance study, nor a study proving it meets such criteria in terms of accuracy or efficacy for an AI/algorithm-driven device.

Based on the document, here's what can be extracted and why other points cannot be answered:

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

• Cannot be provided. The document states: "Testing conducted demonstrates that the easyProphy Series Air Polish Devices fulfills the prospectively defined performance specifications." However, it does not list what those performance specifications (acceptance criteria) are, nor does it provide specific quantitative results of the performance. It only makes a general statement of fulfillment.

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

• Cannot be provided. The document explicitly states: "Discussion of Clinical Tests Performed: None". This device's clearance was based on substantial equivalence to predicate devices and non-clinical tests, not a clinical performance study.

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)

• Cannot be provided. No clinical tests were performed, thus no ground truth for a test set was established using experts.

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

• Cannot be provided. No clinical tests were performed, so no adjudication method was used for a test set.

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

• Cannot be provided. This device is a dental air polisher, not an AI or imaging device that would involve human readers or AI assistance. No MRMC study was conducted.

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

• Cannot be provided. This device is a physical dental instrument, not an algorithm.

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

• Cannot be provided. As no clinical tests were performed, no ground truth types were established for performance evaluation against. The "ground truth" for this device's safety and effectiveness relies on its similarity to legally marketed predicate devices and the non-clinical tests confirming stated performance specifications.

8. The sample size for the training set

• Cannot be provided. This device is a physical dental instrument, not an AI model requiring a training set.

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

• Cannot be provided. As above, this is not an AI/algorithm device.

Summary of Device Evaluation in the Document:

The device (EasyProphy Series Air Polish Devices) was cleared based on:

• Substantial Equivalence: It was found to be substantially equivalent to predicate devices (K032395, Nakanishi, Incorporated . Prophy-Mate; K092289, Ems Electro Medical Systems Sa ● Ems Air-Flow Handy Perio) in terms of intended use, design, construction, performance characteristics, and materials.
• Non-Clinical Tests: "Testing conducted demonstrates that the easyProphy Series Air Polish Devices fulfills the prospectively defined performance specifications." (Specifics of these specifications and results are not provided in this summary).
• Biocompatibility: The patient-contacting material (type 304 Stainless Steel) was deemed biocompatible due to its common use in medical devices and history of biocompatibility, without requiring new testing.
• Absence of Clinical Tests: No clinical tests were performed.

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