(30 days)
Used for preventive sealing of pits and fissures in the primary and secondary dentition.
DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT is a light curing pit and fissure sealant containing releasable fluoride offers an additional protection of the sealed pits and fissures.
The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874.
The provided text is related to a 510(k) submission for a dental product, DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert involvement, statistical analyses, or specific performance metrics) that would be expected for a typical AI/ML device study report.
The document states: "The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874." This is the only mention of a standard or performance criteria being met.
Therefore, I cannot provide a detailed answer for many of your points because the necessary information is simply not present in the provided text.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO Standard 6874 | Meets ISO Standard 6874 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. This document refers to "performance data" generally but gives no specifics. This is a material (sealant) and not a data-driven device.
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. This is a physical dental sealant, not a device that requires expert-established ground truth for a diagnostic or AI-driven task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 not an AI/ML device, nor a diagnostic device that would involve human "readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental sealant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical properties, "ground truth" would typically refer to validated measurement techniques against the ISO standard. No specific details are provided beyond stating it meets ISO 6874.
8. The sample size for the training set
- Not applicable. This is a physical dental sealant, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device and Study Information from the Text:
- Device Name: DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT
- Intended Use: Preventive sealing of pits and fissures in primary and secondary dentition.
- Key Performance Claim: "The physical properties of DYRACT® SEAL COMPOMER PIT & FISSURE SEALANT meet ISO Standard 6874."
- Basis for Equivalence: Similarity in composition to predicate devices (K982564 Delton® FS Direct Delivery System, K982395 Dyract® Flow Restorative), prior use of all components in legally marketed devices, performance data (unspecified detail beyond ISO compliance), and negative Ames test results.
- Biocompatibility: Not explicitly stated that new biocompatibility studies were done for the final formulation, but states they are "not necessary, due to the prior use of all components in DENTSPLY legally marketed devices" and "previous biocompatibility testing" (likely on individual components).
The provided text is a 510(k) summary focusing on substantial equivalence for a material, not a detailed technical report for an AI/ML device testing study.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. 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.(b)
Classification. Class II.