(190 days)
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.
This document describes the FDA's clearance of the EtchPro® Etching Gel (K200462) as substantially equivalent to a predicate device. The information provided outlines the non-clinical performance data used to demonstrate this equivalence.
Here's an analysis of the provided text in the context of your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format in the way one might expect for a quantitative medical device study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance data presented shows a direct comparison of key attributes between the subject device (EtchPro® Etching Gel) and a predicate/reference device (Acid Etch Gel (Etch-Rite), with Etch-Rite Royale as an additional predicate).
| Test Item | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (EtchPro® Etching Gel) |
|---|---|---|
| Phosphoric Acid Concentration | Equivalent to predicate (e.g., 38% for reference, 37% for predicate) | Tested (implied to be comparable) |
| pH | Equivalent to predicate | Tested (implied to be comparable) |
| Viscosity | Equivalent to predicate (e.g., "soft gel" or similar rheological properties) | Tested (implied to be comparable) |
| Biocompatibility | Equivalent to predicate (demonstrates no adverse biological reactions) | Demonstrated to be substantially equivalent |
| Ingredients | Generally similar, with minor differences like excipients (e.g., glycerin) | 38% phosphoric acid, Silica, Glycerin, Colorant |
| Consistency | "Soft gel" (same as predicate device) | Soft gel |
| Color | "Dark blue" (same as predicate device) | Dark blue |
| Solubility in water | 100% (same as predicate device) | 100% |
Study Proving Acceptance Criteria:
The study that proves the device meets the "acceptance criteria" (defined as substantial equivalence to predicate devices) is a non-clinical performance study involving side-by-side comparative testing.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size used for the non-clinical performance tests (phosphoric acid concentration, pH, and viscosity). It only states that "side-by-side performance tests... were conducted."
- Data Provenance: The document does not specify the country of origin of the data. It also does not specify whether the data was retrospective or prospective. Given the nature of bench testing, it would generally be considered prospective data collected for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The ground truth for this type of non-clinical device (etching gel) is established by objective laboratory measurements of its physical and chemical properties, not by expert consensus or interpretation of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where expert interpretation or consensus is required. For non-clinical bench testing, results are typically determined by direct measurement and analysis according to established laboratory protocols.
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 not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device itself (etching gel) is a standalone product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance tests (phosphoric acid concentration, pH, viscosity, biocompatibility) is established by objective, measurable laboratory standards and comparative data against legally marketed predicate devices. For biocompatibility, this would involve standardized in-vitro or in-vivo tests with defined endpoints, where the "truth" is whether the material elicits a harmful biological response.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, 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.
§ 872.3200 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.