(83 days)
These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.
These materials consist of a gel containing ortho-phosphoric acid.
This document is a 510(k) Premarket Notification for a dental etching gel, primarily focusing on demonstrating substantial equivalence to a predicate device. It explicitly states, "NON-CLINICAL DATA: Non-clinical testing includes tests for pH, acid content, adhesion and water washability. The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy. The test for adhesion indicates better adhesion of the subject device. The device is intentionally more viscous than the predicate device to improve adhesion after placement. The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal. CLINICAL DATA: There is none applicable."
Therefore, based on the provided text, the device relies on non-clinical data for its acceptance criteria, and clinical data is not applicable. Without specific acceptance criteria being quantified (e.g., pH range, minimum adhesion strength, maximum washability time), a detailed table comparing acceptance criteria to device performance is not possible from this text alone.
Here's an attempt to outline the information based on the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not Quantified in Text) | Reported Device Performance |
|---|---|---|
| pH | Comparable to predicate device | Comparable to predicate device within formulation and experimental accuracy |
| Acid Content | Comparable to predicate device | Comparable to predicate device within formulation and experimental accuracy |
| Adhesion | Satisfactory adherence to tooth material, improved over predicate device | Improved adhesion compared to predicate device (intentionally more viscous) |
| Water Washability | Satisfactory removal after etching | Satisfactory washability, though marginally less easy than predicate due to increased viscosity |
2. Sample Size and Data Provenance
- Sample size for the test set: Not mentioned.
- Data provenance: Not explicitly stated, but the tests were "non-clinical." This typically implies laboratory testing conducted by the manufacturer. The manufacturer is based in England.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable as the data is non-clinical and does not involve expert-established ground truth for a test set in the conventional sense (e.g., diagnostic interpretation).
4. Adjudication Method
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not done. The document explicitly states: "CLINICAL DATA: There is none applicable."
6. Standalone Algorithm Performance Study
- Not applicable. This is a physical dental product, not an algorithm.
7. Type of Ground Truth Used
- The ground truth for the non-clinical tests would have been established through standardized laboratory testing methods and measurements for pH, acid content, adhesion, and washability. For example, pH would be measured with a pH meter, acid content through titration, and adhesion/washability through specific physical tests, with the predicate device serving as a benchmark for "comparable" or "satisfactory" performance.
8. Sample Size for the Training Set
- Not applicable. This is not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.