(97 days)
A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
Thixotropic dental etchant gel with 37% phosphoric acid
The provided text is a 510(k) summary for a dental etchant gel, not a study involving AI or complex medical device performance metrics like sensitivity, specificity, or reader studies. Therefore, many of the requested categories related to AI systems, clinical trials, and expert adjudication are not applicable.
However, I can extract the relevant information regarding the acceptance criteria (comparative performance to a predicate device) and the study that "proves" the device meets these criteria, based on the provided text.
Device Name: Jade 37% Phosphoric Acid Etchant Gel
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Jade 37% Phosphoric Acid Etchant Gel are based on demonstrating substantial equivalence to its predicate device, Seity 37% Phosphoric Acid Etchant Gel (K112597). This equivalence is primarily established through comparisons of technological characteristics and bench testing results.
| Acceptance Criteria (Comparison to Predicate Device) | Predicate Device Performance (Seity 37% Phosphoric Acid Etchant Gel) | Reported Device Performance (Jade 37% Phosphoric Acid Etchant Gel) | Outcome |
|---|---|---|---|
| Phosphoric Acid Concentration | 37% | 37% | Equivalent |
| Consistency | Thick gel | Thick gel | Equivalent |
| Color | Blue or Green | Blue or Green | Equivalent |
| Odor | No characteristic | No characteristic | Equivalent |
| Viscosity (cps) | 40,000 cps | 60,000 cps | Comparable* |
| pH | 1.20 | 1.52 | Comparable* |
| Shelf-Life | Appears to be 2-years (based on label example in MISC files) | Proposed 2-years (based on existing shelf-life studies) | Comparable |
| Intended Use | A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations. | A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations. | Equivalent |
| Technological Characteristics | Thixotropic gel with 37% phosphoric acid, thickeners, and emulsifiers. | Thixotropic gel with 37% phosphoric acid, thickeners, and emulsifiers. Coloring agents are also similar. | Substantially Equivalent |
Note: While viscosity and pH values are not identical, the submission asserts that bench testing demonstrates the equivalence of Jade to the predicate device, implying these differences are not clinically significant for the intended use and do not raise new issues of safety or efficacy. The conclusion specifically states that "Even though the chemical compositions are not identical, bench testing has demonstrated that Jade has comparable material properties and performance."
2. Sample size used for the test set and the data provenance
The document describes "bench testing" without specifying a particular sample size for each characteristic tested. The data provenance is derived from these bench tests, which are laboratory-based and not tied to patient data or specific countries of origin in this context. It's prospective in the sense that Dharma Research likely conducted these tests specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert consensus for ground truth but rather laboratory measurements comparing physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert adjudication in the context of clinical outcomes or imaging reviews.
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-assisted device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the established properties and performance of the legally marketed predicate device (Seity 37% Phosphoric Acid Etchant Gel, K112597) and the measured chemical/physical properties of both the predicate and the new device through laboratory bench testing.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.