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The DELTON® FS DIRECT DELIVERY SYSTEM is used for preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

DELTON® FS PIT & FISSURE SEALANT is a radiopaque, light cured, resinous material designed for application to the occlusal surfaces of caries susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food and debris. DELTON® FS DIRECT DELIVERY SYSTEM also includes Delton® Etchant Gel, a DENTSPLY legally marketed device (K942031). The sealant is dispensed to the acid-etched tooth via an individually filled cartridge inserted into the applicator handle (Direct Delivery System).

The provided text describes a 510(k) premarket notification for a dental device, DELTON® FS DIRECT DELIVERY SYSTEM, and focuses on its substantial equivalence to a predicate device. This type of submission generally does not include detailed acceptance criteria or a comprehensive study report with quantitative performance metrics as would be found in a De Novo or PMA submission.

However, based on the text, we can infer the primary "acceptance criterion" and the "study" that supports it:

Primary Acceptance Criterion: The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent to or better than those of DELTON® Plus Pit & Fissure Sealant (the predicate device).

Study Proving Acceptance: The submission states: "The physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant." This implies a comparison study was conducted to demonstrate this equivalence or superiority.

Here's a breakdown based on your requested information, with limitations due to the nature of the provided document:

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

   Acceptance Criterion	Reported Device Performance
   Physical properties equivalent or better than predicate device	Physical properties of DELTON® FS PIT & FISSURE SEALANT are equivalent or better than those of DELTON® Plus Pit & Fissure Sealant.
   Nearly equivalent composition to predicate device	Nearly equivalent composition.
   Safety and effectiveness for indicated uses	Supported by prior use of components in predicate, nearly equivalent composition, and performance data.

2. Sample size used for the test set and the data provenance

   • Sample size: Not specified.
   • Data provenance: Not specified, but implied to be from internal testing or comparison against established properties of the predicate device. The document does not indicate country of origin 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

   • Not applicable to this type of submission. The "ground truth" here is the established physical properties of a dental sealant, likely measured in a lab, rather than expert interpretation of clinical data.

4. Adjudication method for the test set

   • Not applicable. This is not a study involving human readers or clinical interpretation requiring 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

   • No. This device is a dental sealant, not an AI-powered diagnostic tool. MRMC studies are irrelevant.

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

   • No. This is a physical dental material, not an algorithm.

7. The type of ground truth used

   • Laboratory measurements of physical properties: The "ground truth" for the comparison is the established physical properties of the predicate device (DELTON® Plus Pit & Fissure Sealant) and the newly measured physical properties of DELTON® FS PIT & FISSURE SEALANT.

8. The sample size for the training set

   • Not applicable. This is not a machine learning model.

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

   • Not applicable. This is not a machine learning model.

Summary of the "Study":

The "study" referenced in the 510(k) summary is a comparative analysis of the physical properties of the new device (DELTON® FS PIT & FISSURE SEALANT) against its predicate device (DELTON® Plus Pit & Fissure Sealant). The applicant states that the new device's properties are "equivalent or better." Additionally, the submission relies on the "nearly equivalent composition" to the predicate device and the fact that "all of the components found in DELTON® FS PIT & FISSURE SEALANT have been used in the predicate dental device" to argue for its safety and effectiveness without requiring extensive new clinical testing or toxicity testing beyond what was already established for the predicate. This approach is standard for demonstrating substantial equivalence in many 510(k) submissions for similar devices.

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