(22 days)
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
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (KaVo PROPHYpearls) |
|---|---|
| Safety: Biocompatibility of the new powder component. | Calcium carbonate is inherently biocompatible and recognized in the Code of Federal Regulations as generally recognized as safe (GRAS). |
| Effectiveness: Equal or better performance in removing plaque deposits and stains from teeth. | Studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. |
| Indications for Use: Identical intent. | 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. |
| Mechanism of Action: Similar mechanism. | Projection of a mixture of water, air, and calcium carbonate onto tooth surfaces (similar to predicate's projection of water, air, and sodium bicarbonate). |
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.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.