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• Sealing pits and fissures, damaged enamel surfaces and exposed dentin surfaces e of teeth to prevent caries
• Protective coating for tooth surfaces predisposed to caries or on early non- cavitated lesions (org. including use in tooth brush abrasion and root surfaces).
  Covering of caries predilection sites during orthodontic treatment

SPK Sealant is moisture activated, light-cured, fluoride releasing pit and fissure sealant that can be applied with or without a phosphoric acid etch step. SPK Sealant is classified as a pit and fissure sealant because the device is composed of a methacrylate-based resin intended for sealing pits and fissures or other tooth surfaces to prevent cavities.

The provided 510(k) summary for K091632, "SPK Sealant," does not contain a detailed study section with acceptance criteria and a comprehensive study showing device performance. This type of information is usually found in a separate biocompatibility report, performance testing report, or clinical study report, which is referenced or summarized within a more detailed 510(k) submission but often not fully included in the public 510(k) summary document itself.

The document states: "Based on the indications for use, technological characteristics, and comparison of the predicate devices, the SPK Sealant has been shown to be safe and effective for its intended use." This is a general statement of equivalence rather than a detailed report of a specific study to meet acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To answer your request, a more detailed study report or performance testing summary would be required.

However, I can extract the information that is present:

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

• Not explicitly provided in the given text. The document focuses on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable, but it does not present specific acceptance criteria (e.g., bond strength, fluoride release, retention rate) and then show how this new device met those criteria through a study.

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

• Not provided.

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/Not provided. This type of information is typically related to diagnostic imaging or clinical interpretation studies, which is not the nature of this dental sealant submission.

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

• Not applicable/Not provided.

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/Not provided. This is relevant to AI/diagnostic imaging devices, not a dental sealant.

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

• Not applicable/Not provided.

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

• Not explicitly stated/Not applicable. Performance for dental sealants is typically assessed through characteristics like bond strength, wear resistance, fluoride release, and clinical retention over time, rather than a "ground truth" as might be used in a diagnostic test.

8. The sample size for the training set:

• Not applicable/Not provided. This is relevant for machine learning algorithms, which this device is not.

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

• Not applicable/Not provided.

In summary, the provided 510(k) summary primarily focuses on demonstrating substantial equivalence to existing predicate devices based on indications for use and technological characteristics, rather than detailing a specific, comprehensive study with explicit acceptance criteria and performance data for this particular device.

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