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PacSeal™ Pit & Fissure Sealant is intended for use as:

• Seal the pits and fissures in teeth

PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.

Here's a breakdown of the acceptance criteria and study information for the PacSeal™ Pit & Fissure Sealant as derived from the provided document:

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria in the manner of a novel device. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device's performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it compares the subject device's performance to that of predicate devices, implicitly suggesting that performance comparable to or better than the predicate is acceptable.

Note: For "Compressive Strength," the subject device (181 MPa) is lower than the predicate (210 MPa). The document still concludes substantial equivalence, suggesting that this difference was deemed acceptable in the context of overall performance and "equivalent to the predicate" claim for other properties.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the performance tests (e.g., number of specimens for depth of cure, strength tests).
The data provenance is not explicitly stated beyond being presented in a 510(k) summary by Pac-Dent International, Inc. These types of tests are typically in-vitro laboratory tests, not clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the data provided. The "ground truth" for these physical property tests is based on standardized laboratory measurements (e.g., ISO standards) and not on expert consensus from human readers or clinicians.

4. Adjudication Method for the Test Set

This is not applicable as the tests are for physical properties measured in a lab, not for diagnostic or interpretive tasks requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes the physical and chemical characteristics of a dental sealant, not an AI or imaging device that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not relevant to the device described. The device is a physical dental sealant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (e.g., depth of cure, strength, film thickness) is based on standardized laboratory test methods (e.g., ISO 6874-2005, ISO 4049-2009).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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