(112 days)
PREVENTECH Prophylaxis Paste with Fluoride is intended to be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
PREVENTECH Prophylaxis Paste with Fluoride is an oral cavity abrasive polishing agent containing sodium fluoride in a blend of enamel polishing and cleaning abrasive agents in a paste form designed for professional application to the teeth during the course of standard dental hygiene procedures. PREVENTECH Prophylaxis Paste with Fluoride is sweetened with Xylitol and offered in various grit levels and various flavors.
The standard mode of application for PREVENTECH Prophylaxis Paste with Fluoride is by use of a low speed Dental Handpiece and accessories, (21 § CFR 872.4200) and a Prophylaxis Cup, (21§ CFR 872.6290).
The provided text is for a 510(k) summary for a prophylaxis paste, not a complex medical device with AI or software components requiring a detailed study of its performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information, such as sample size for test sets, expert-established ground truth, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.
However, I can extract the relevant information from the document regarding the device's performance criterion and the study used to establish substantial equivalence.
Acceptance Criteria and Device Performance for PREVENTECH Prophylaxis Paste with Fluoride
The primary performance criterion for the PREVENTECH Prophylaxis Paste with Fluoride to establish substantial equivalence was its Relative Enamel Abrasion (REA). The predicate device's REA performance served as the acceptance criterion that the proposed device needed to meet.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Predicate Device Performance) | Reported Device Performance (PREVENTECH Prophylaxis Paste with Fluoride) | Study Reference |
|---|---|---|
| Similar REA performance to ENAMEL PRO Professional Prophylaxis Paste with ACP (K062166) | Demonstrates similar performance for enamel abrasion. (Identified as Prophy Paste C) | Final Report, Relative Enamel Abrasion (REA) Study, REA09-284 |
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: Not specified in the provided summary.
- Data Provenance: The study "Relative Enamel Abrasion (REA) Study, REA09-284" was conducted. The country of origin of the data is not specified in the summary. The study appears to be laboratory-based rather than involving human subjects (retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
- This is not applicable as the test evaluates a physical property (enamel abrasion) of a dental paste, not the interpretation of medical images or data by experts. The ground truth would be established through standardized laboratory testing protocols for REA.
4. Adjudication Method
- Not applicable for this type of laboratory performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of medical images/data, which is not the case for a prophylaxis paste.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is a dental paste, not an algorithm. The REA study is a standalone performance study of the paste itself.
7. Type of Ground Truth Used
- The ground truth for the REA study would be established through a standardized laboratory measurement of enamel abrasion, likely using a validated in-vitro method.
8. Sample Size for the Training Set
- Not applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.