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Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.

UltraSeal ID is a 58% filled, light-cure, radiopaque, methacrylate-based, thixitropic resin sealant. UltraSeal ID technology provides visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

The provided document is a 510(k) premarket notification for a dental pit and fissure sealant called UltraSeal ID. This document describes the device and its equivalence to existing predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared devices (UltraSeal XT plus and Seal-n-Glo) to gain market approval as a Class II medical device. The "Brief Description of testing performed" section lists various physical and mechanical properties that were tested (Hardness, Compressive Strength, Shrinkage, Shear Peel, Film Thickness, Viscosity/Rheometry, Sorption/Solubility), and states preferences for the results (e.g., "prefer to stay within our competitors range," "prefer higher numbers," "prefer low numbers"). However, it does not specify quantitative acceptance criteria or report the actual performance metrics for UltraSeal ID against these criteria.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document lists physical tests performed and general preferences, but no specific numerical acceptance ranges or the actual performance of UltraSeal ID.
2. Sample size used for the test set and the data provenance: Not specified in the document. The testing described is "during the R & D phase" and is comparative, but details on sample sizes or data provenance (e.g., in vivo/in vitro, country of origin, retrospective/prospective) are omitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes physical property testing, not a clinical study involving expert assessment or ground truth establishment in a clinical context.
4. Adjudication method for the test set: Not applicable. This document describes physical property testing, not a clinical study involving adjudication.
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 dental sealant, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental sealant, not an AI-powered device.
7. The type of ground truth used: For the physical/mechanical tests, the "ground truth" would be the measured properties of the predicate devices or established industry standards, but these are not explicitly stated as "ground truth." The document refers to comparing UltraSeal ID to UltraSeal XT plus and Seal-n-Glo.
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.

In summary, the provided 510(k) pertains to a pit and fissure sealant and outlines physical/mechanical tests performed for comparison to predicate devices, but it does not detail specific acceptance criteria, study sample sizes, or clinical evaluation results in the manner requested for an AI/diagnostic device. The "Clinical Summary" mentioned states that literature was selected to support safety and efficacy claims, but the details of this literature review are not provided in this excerpt.

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