(126 days)
STEP-I PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the smface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.
STEP-1 PumEtch is a tooth preparation formulation combining a 37% phosphoric acid etch and pumice, a polishing agent, into one gel liquid solution. The product is used to prepare natural tooth surfaces for the application of sealants or direct bond appliances.
This describes the acceptance criteria and study proving the device meets them, based on the provided text:
The document is a 510(k) summary for a dental product called STEP-1 PumEtch, which is a prophylaxis and phosphoric acid etchant. The primary method for proving substantial equivalence to predicate devices is through comparative performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Proxy) | Reported Device Performance (Comparative to Predicate) |
|---|---|
| No statistically significant difference in Shear Bond Strength (SBS) | Demonstrated no statistically significant difference in SBS |
| No statistically significant difference in pH | Demonstrated no statistically significant difference in pH |
Note: The document implies these are the acceptance criteria by stating that the comparative performance testing "demonstrated there is no statistically significant difference between the subject and predicate devices" for these metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the Shear Bond Strength (SBS) and pH comparative performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The study focuses on direct physical and chemical property comparisons (SBS, pH) rather than expert-based ground truth.
4. Adjudication Method for the Test Set
This is not applicable and not provided. The study design involves direct measurement and comparison of physical/chemical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. The device is a dental etchant, not an AI or imaging device that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. A standalone algorithm study was not done. The device is a physical/chemical product, not an algorithm.
7. Type of Ground Truth Used
The ground truth or reference for evaluation in this context is the performance of legally marketed predicate devices in terms of Shear Bond Strength and pH. The study aims to show that the new device performs equivalently to these established benchmarks.
8. Sample Size for the Training Set
This is not applicable and not provided. The device is a physical/chemical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not provided for the same reasons as above.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.