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DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.

The provided document describes a 510(k) premarket notification for a dental product called DIAETCH, which is a phosphoric acid etchant. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria or conducting clinical efficacy studies with human subjects.

Therefore, the acceptance criteria and study information requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size for human reader improvement with AI) are not applicable to this type of medical device submission. These details are typically required for AI/ML-driven devices or those requiring clinical performance data to establish safety and effectiveness.

This submission relies on non-clinical performance data to demonstrate substantial equivalence to its predicate devices (Seity 37% Phosphoric Acid Etching Gel and Acid Etchant).

Here's a breakdown of the relevant information provided:

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

The acceptance criteria are implicitly based on demonstrating similar physical and chemical properties to the predicate devices and passing standard biocompatibility tests.

Regarding the other points of your request:

• 2. Sample sized used for the test set and the data provenance: Not applicable. The tests performed are laboratory-based physical/chemical and biocompatibility tests, not clinical test sets with patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this submission. Biocompatibility tests follow established standard protocols.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical data adjudication, which was not part of this submission.
• 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 device is a dental etchant, not an AI-assisted diagnostic tool or system that involves human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for this type of device. The "ground truth" here is adherence to specified physical/chemical parameters and passing international biocompatibility standards.
• 8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. See point 8.

In summary, the substantial equivalence for DIAETCH was demonstrated through:

• Comparison of Indications for Use: Showing that DIAETCH's intended use is substantially similar to the predicate devices.
• Comparison of Technological Characteristics: Demonstrating similar physical and chemical compositions, and properties (pH, viscosity, consistency, color).
• Non-Clinical Performance Data: Passing standard biocompatibility tests (cytotoxicity, sensitization, oral mucosa irritation) according to ISO 10993 series, which confirm the device's biological safety.

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