(66 days)
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin, enamel or glass ionomers as one step in tooth restoration.
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in a soft gel that does not dry out quickly, that flows through small applicator tips and that washes off readily. Etch-Rite Supreme is colored dark purple for contrast with tooth enamel and easy visualization.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Pulpdent Etch-Rite™ Supreme device.
It's important to note that this document is a 510(k) summary for a dental etchant, which is a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI device performance evaluation (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of product and are not present in the document. The evaluation of this device is based on bench testing and substantial equivalence to predicate devices.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Specific Gravity | 1.280 |
| Solubility in Water | 100 % |
| pH | 1.0 |
| Appearance and Odor | Dark purple gel with mild, characteristic odor |
| Shelf-Life | Two years |
2. Sample sized used for the test set and the data provenance:
- Not applicable. This is a physical dental etchant, not a software device. The "test set" described in the context of AI/SaMD for ground truth and performance validation is not relevant here. The performance testing refers to bench tests on the product itself. The document does not specify the number of samples used for each bench test, but it is implied that standard laboratory practices for material testing were followed.
- Data Provenance: The bench testing was conducted by Pulpdent Corporation, presumably at their facilities. No country of origin for data (in the sense of patient data) is relevant here, as it's a material science evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of clinical expert consensus for imaging or diagnostic algorithms is not relevant for a chemical etchant. The "truth" for the bench tests (e.g., pH value, specific gravity) is determined by objective scientific measurement.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used to establish ground truth from multiple expert opinions, which is not relevant for the bench testing of a chemical product.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical dental material, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical etchant, not an algorithm. Standalone algorithm performance is not a concept applied here.
7. The type of ground truth used:
- For the bench tests, the "ground truth" is defined by objective physical and chemical measurements (e.g., specific gravity, pH, solubility, observation of appearance/odor, and stability testing for shelf-life). These are intrinsic properties of the material and are measured directly.
8. The sample size for the training set:
- Not applicable. This device is a chemical product, not a machine learning model. The concept of a "training set" for an algorithm that learns patterns from data is not relevant.
9. How the ground truth for the training set was established:
- Not applicable. (As per point 8).
Study Proving the Device Meets Acceptance Criteria
The document describes the "Summary of Performance Testing - Bench" as the study proving the device meets the acceptance criteria.
The study concludes that "Etch Supreme performs as intended" based on the tabulated bench test results. The primary strategy for regulatory approval and demonstrating safety and effectiveness is substantial equivalence to predicate devices, rather than extensive clinical efficacy trials directly for this type of product.
The statement "From the above comparisons, the bench testing, a search of the relevant scientific literature and the organizational experience with the Etch-Rite line of etchants, it can be concluded that Etch-Rite Supreme is substantially equivalent in design, composition, performance and intended use to the predicate products." highlights the approach.
Predicate Devices for Comparison:
- Pulpdent Etch-Rite™ 38% Phosphoric Acid Etching Gel (K882576)
- Pulpdent Etch Royale™ 37% Phosphoric Acid Etching Gel (K031915)
The comparison table (in section {0}) shows the new device's chemical composition (36% Phosphoric Acid, Silica gel, Propylene glycol), consistency (Soft gel), applicator tip (25 gauge, pre-bent), color (Dark purple), and intended use (Etch dentin, enamel and glass ionomer cements) are substantially equivalent to the predicates, with minor variations (e.g., 36% vs. 38% and 37% phosphoric acid, dark purple vs. blue color) that are deemed not to raise new questions of safety or effectiveness. The bench test results then confirm that these minor compositional differences still result in a product that performs functionally as expected for an etchant.
§ 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.