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The Ascent Pit & Fissure Sealant System is applied after the intended surface is prepared, etched, and treated as necessary. The material is applied to the site directly from the material packaging, usually in the form of a syringe or other hand-held dispensing apparatus. The sealant is worked into and around the affected area with a tip or brush to ensure an adequate and thorough coat. The material is then polymerized using a suitable dental polymerization light source. This system is marketed and sold only to licensed professional dentists.

Indications For Use:
Ascent Pit & Fissure Sealant is indicated for:

• The sealing of pits and fissures

The Ascent Pit & Fissure Sealant System is a comprehensive light-cured system designed to fill and seal the pits and fissures of teeth. The integrated nano-filler technology provides excellent wear and strength properties. The methacrylate based resin system provides an excellent seal and superior adhesion to etched enamel. The system may alternately be supplied either with or without a pretreatment phosphoric acid etchant.

This 510(k) summary does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be associated with a medical device AI/ML study. This document describes a traditional dental device (pit and fissure sealant), not a software-driven or AI-powered one.

Therefore, many of the requested fields cannot be filled as they are explicitly related to studies evaluating the performance of an AI/ML algorithm. The document explicitly states "Performance Standards: None" and "Performance Data: See Part 7: Performance Data," but "Part 7" is not included in the provided text.

Based on the available text:

Acceptance Criteria and Device Performance

Since this is a conventional dental sealant and not a software/AI device, acceptance criteria would typically relate to material properties (e.g., bond strength, wear resistance, viscosity, curing time) and biocompatibility, rather than diagnostic accuracy metrics. The provided document does not specify quantitative acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.

Study Details (Based on the provided text, many fields are not applicable or not available)

1. Sample size used for the test set and the data provenance: Not applicable. This is a material-based device, not an AI/ML algorithm tested on a dataset of images/data. The document does not describe a "test set" in the context of evaluating algorithm performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sealant device would be established through laboratory testing (e.g., mechanical tests, chemical analysis) or clinical trials, not expert consensus on annotated data.
3. Adjudication method for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: For a dental sealant, ground truth typically involves:
   • In-vitro testing: Laboratory measurements of material properties (e.g., tensile strength, compressive strength, modulus of elasticity, wear resistance, bond strength to enamel/dentin, polymerization shrinkage, water sorption, solubility).
   • Biocompatibility testing: As per ISO standards for medical devices.
   • Clinical observation (if clinical trials were performed, though often not required for 510(k) for devices substantially equivalent to well-understood predicates): Assessment of retention rates, caries prevention, post-operative sensitivity.
     The document states "Performance Data: See Part 7," which is not provided.
7. The sample size for the training set: Not applicable. There is no "training set" in the context of machine learning for this device.
8. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The provided document, K053089 for Ascent Pit & Fissure Sealant, describes a traditional dental material. Its substantial equivalence is based on similar composition, indications for use, and application methods to a predicate device (Seal-Rite Pit and Fissure Sealant, K963921). The document explicitly states "Performance Standards: None" and references "Part 7: Performance Data" which is not included. Therefore, detailed acceptance criteria, study methodologies, and performance metrics (especially those relevant to AI/ML devices) are not present in this excerpt.

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