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Peak® Z is intended for use as a surface treatment for restorations made of the following materials: Zirconia, Aluminum oxide, Metal/Alloy, Titanium.

Peak® Z is a single component surface treatment that enhances bond values when applied to zirconia, alumina, and metal/alloys. It contains 12methacryloyIdoeceylphosphate (MDP), which produces a chemical bond that significantly increases adhesion between a resin-based material and the bonding surface of the restoration. Peak® Zr Primer can be applied through a syringe delivery or brush and bottle. Peak® Z is supplied in a pre-mixed syringe for easy delivery and no waste, and also in bottles with brushes that can be directly applied to surfaces.

I am sorry, but I cannot provide a detailed analysis of acceptance criteria, study design, and results based on the provided text. The document is a 510(k) summary for a dental bonding agent (Peak® Z) and focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report from the R&D and clinical phases.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

Key Missing Information for a Comprehensive Answer:

• Explicit Acceptance Criteria: The document mentions "acceptance criteria" generally but does not list specific quantitative or qualitative acceptance criteria that the device must meet in the same format as the table requested.
• Detailed Study Results (Quantitative): While it mentions "bench tests" and "literature review," it does not provide the actual raw data, statistical analysis, or performance metrics (e.g., specific bond strength values with standard deviations, p-values, or confidence intervals). It only states that Peak® Z "performs as well or better than the predicate device."
• Test Set/Training Set Details: There is no mention of distinct test sets or training sets, as the studies described are bench tests comparing the new device to a predicate and a literature review.
• Expert Details, Adjudication, MRMC, Standalone Performance: These concepts are typically relevant for AI/ML-based diagnostic devices, which is not the nature of this dental bonding agent. Therefore, this information is not present.
• Ground Truth Definition and Establishment: For bench tests, the "ground truth" is the measured physical property (e.g., shear bond strength). For the literature review, it's about established safety and efficacy from existing products, not a directly established "ground truth" on a new dataset.

What can be extracted or reasonably inferred from the text regarding the provided questions:

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

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 for Bench Tests: Not explicitly stated. The document only mentions "various surfaces" for shear bond tests.
• Data Provenance: "In-vitro test," "in-house testing," and comparison to a "predicate device currently on the market." This suggests laboratory-based testing, likely conducted by the applicant (Ultradent Products, Inc.) or contracted labs. The literature review provides "safety and effectiveness of this product," which would be based on existing published studies. This would be prospective for the bench tests (new measurements) and retrospective for the literature review (using existing data).
• Country of Origin: Implied to be the US, as the applicant is a US company (South Jordan, UT) and the submission is to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of results for ground truth. For the bench tests, "ground truth" is established by direct physical measurement (e.g., bond strength).

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

• Not applicable for this type of device and testing.

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-assisted diagnostic or interpretive device.

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

• Not applicable. This is a physical product (dental bonding agent), not an algorithm.

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

• For Shear Bond Strength tests: The ground truth is the measured bond strength (quantitative physical characteristic).
• For Biocompatibility tests: The ground truth is determined by the results of standardized ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for sensitization).
• For Stability tests: The ground truth is the measured performance/functionality over time under different conditions.
• For overall safety and effectiveness: This was supported by a literature review, relying on previously established scientific and clinical evidence for similar products.

8. The sample size for the training set

• Not applicable. The document describes bench testing and a literature review for substantial equivalence, not the training of an algorithm or model.

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

• Not applicable (as above).

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