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PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.

This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The modification involves changing the powder from sodium bicarbonate to calcium carbonate.

The provided text describes a 510(k) summary for the KaVo PROPHYpearls dental cleaning powder. This submission focuses on demonstrating substantial equivalence to a predicate device by changing the powder component from sodium bicarbonate to calcium carbonate. The study mentioned is for proving this equivalence, not necessarily setting acceptance criteria in a strict sense for a medical device's diagnostic performance. Therefore, my response will interpret "acceptance criteria" and "device performance" in the context of demonstrating substantial equivalence for a cleaning powder.

Acceptance Criteria and Device Performance for KaVo PROPHYpearls

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify quantitative metrics for "equal or better" performance, which is typical for 510(k) submissions focusing on substantial equivalence rather than a new technology's performance thresholds.

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

The document states: "studies have shown that the calcium carbonate powder does an equal or better job of removing plaque." However, it does not provide details on the sample size for these studies or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the performance studies.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key component. The PROPHYpearls is a cleaning powder, not a diagnostic tool requiring human interpretation comparison.

6. Standalone Performance Study

The studies mentioned ("studies have shown that the calcium carbonate powder does an equal or better job of removing plaque") are essentially standalone performance evaluations of the calcium carbonate powder's efficacy in removing plaque, compared to the sodium bicarbonate powder of the predicate device. However, no specific details of these studies (e.g., methodology, endpoints, quantitative results) are provided beyond the summary statement.

7. Type of Ground Truth Used

The "ground truth" for the performance studies would likely have been direct observation or measurement of plaque and stain removal. This could involve:

• Visual assessment of tooth surfaces before and after cleaning.
• Quantitative measurements using plaque indices or stain scores.
• Potentially, laboratory or in-vitro tests mimicking the cleaning process.

The document does not explicitly state the type of ground truth used.

8. Sample Size for the Training Set

This submission is for a medical device (a powder used with a handpiece) and not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning.

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

As explained in point 8, there is no training set for this device.

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