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Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.

This document is a 510(k) Summary for a medical device called Enamelast™, a fluoride varnish. It aims to demonstrate substantial equivalence to a predicate device, Flor-Opal Varnish White.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for the device, but rather a "Substantial equivalence comparison" table (Table 7-1) that compares the characteristics of Enamelast™ with a predicate device (Flor-Opal Varnish White). This comparison implicitly serves to demonstrate that Enamelast™ meets performance standards similar to a legally marketed device.

Here's a reinterpretation of Table 7-1, focusing on characteristics that could be considered performance indicators:

The document states, "The data supports the functionality of Enamelast." and "In summary, this submission demonstrates that Enamelast is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicate and comparable product for its intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF." However, it does not provide any specific sample sizes for this testing.

The data provenance is stated as "In-house comparison testing," suggesting the tests were conducted by Ultradent Products, Inc. No information is given about the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the document describes a chemical/physical dental product, not an AI/diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here would be the measured physical and chemical properties and biocompatibility results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for the type of device and testing described. Adjudication methods like "2+1" typically apply to image interpretation or clinical diagnosis where multiple experts evaluate a case and resolve discrepancies. The testing described involves laboratory measurements of material properties and biocompatibility.

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

This is not applicable. The device is a fluoride varnish, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical product (fluoride varnish), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance would be derived from:

• Physical and Chemical Testing: Direct measurements of properties like pH, film thickness, fluoride uptake, and varnish retention.
• Biocompatibility Testing: Laboratory assays (e.g., cytotoxicity, oral mucosa irritation, genotoxicity, sensitization) according to established standards.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that would require a "training set."

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

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UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.

UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement. UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.

The provided text describes a 510(k) submission for the dental cement UltraCem™ and primarily focuses on demonstrating its substantial equivalence to a predicate device, K111855 Hy-Bond Resiglass. The study presented is a bench testing comparison, not a clinical study involving human patients or complex AI algorithms. Therefore, much of the requested information regarding AI performance, human readers, ground truth for training sets, etc., is not applicable to this document.

Here's the breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each performance metric. Instead, it states that UltraCem™ is "comparable to Hy-Bond" or that "test results indicate that UltraCem™ is substantially equivalent to the predicate device." The detailed numerical results from "Section 18 Bench Testing" are not included in the provided text.

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: Not explicitly stated for each bench test. The document refers to "samples were prepared," "specimens were allowed to cure," but no specific numbers.
• Data Provenance: The bench tests were "in-house testing," implying the data was generated by Ultradent Products, Inc. The exact country of origin for the data generation and whether it was retrospective or prospective is not detailed, but "in-house testing" strongly suggests prospective lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This study involves bench testing of physical properties of a dental cement, not clinical image analysis or expert review requiring ground truth established by medical experts for diagnostic purposes. The expertise would likely be in materials science and dental product testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As this is a bench testing study comparing physical properties, there is no expert adjudication method like those used for clinical readings or diagnostic AI algorithms. The results would be objectively measured.

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 document describes a traditional 510(k) for a dental cement, involving bench tests. There is no mention or implication of AI or human readers, so an MRMC study or effect size related to AI assistance is irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. There is no algorithm or AI component in this device described in the submission. It is a material-based dental cement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Bench Test Measurements/Predicate Device Comparison: For the physical tests (shear bond, working/setting time, film thickness, flexural strength, radiopacity), the "ground truth" would be the objective measurements obtained in the lab. For substantial equivalence, the performance of UltraCem™ is compared directly to the measured performance of the legally marketed predicate device, K111855 Hy-Bond Resiglass, which effectively serves as the benchmark or "ground truth" for acceptable performance. For biocompatibility, the "ground truth" for not needing direct testing was the identical formulation to the predicate, which had approved ISO 10993 results.

8. The sample size for the training set

• Not Applicable. There is no AI component or machine learning model that would require a training set in this submission.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, there is no ground truth for a training set to be established.

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