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510(k) Data Aggregation
(114 days)
Etch enamel, dentin, and glass ionomer cements.
E Dental Products e-1 etchants are colored 37% phosphoric acid aqueous solution etching gels. E Dental Products e-1 etchants are applied to be step in the tooth restoration process.
This document describes the premarket notification (510(k)) for E Dental Products e-1 etchants, establishing its substantial equivalence to a predicate device. Therefore, it does not describe an AI/ML device or a study involving human readers or ground truth in the way the request specifies. The provided text is a regulatory submission for a dental product, not a description of an AI medical device's performance study.
Thus, I cannot fulfill the request as it pertains to an AI/ML device study.
However, I can extract the acceptance criteria and performance of the dental product as detailed in the document:
1. Table of acceptance criteria and reported device performance:
| Performance Metric | Acceptance Criteria (Predicate: Pulpdent Etch-Royale K031915) | Reported Device Performance (E Dental Products e-1 etchants K152110) |
|---|---|---|
| Chemical composition | 37% phosphoric acid, silica, glycerin, colorant | 37% phosphoric acid, silica, colorant |
| Consistency | soft gel | soft gel |
| Color | dark blue | colored |
| Intended use | Etch enamel, dentin and glass ionomer cements | Etch enamel, dentin and glass ionomer cements |
| Specific gravity @ 25C | 1.30 | 1.31 |
| Solubility in water @ 25C | 100% | 100% |
| pH @ 25C | 1 | 1 |
| Appearance | dark blue soft gel | colored soft gels |
| Shelf life | 2 years | 2 years |
| Odor | mild characteristic | mild characteristic |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device or a clinical study that would involve a test set of data. The submission is based on bench testing and comparison to an existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The evaluation is based on physicochemical properties and intended use comparison.
4. Adjudication method for the test set: Not applicable.
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/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Not applicable. The "ground truth" equivalent here is the established performance and characteristics of the predicate device (Pulpdent Etch-Royale K031915) through its prior 510(k) clearance and market history, and the subject device's adherence to those characteristics through bench testing.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
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