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EAZY PRIMER™ is indicated for use in enhancing bonding between dental ceramics (such as porcelain, lithium disilicate, zirconia or hybrid ceramics) and methacrylate resin-based materials. In addition, EAZY PRIMER™ is indicated for use in enhancing bonding between fractured dental ceramics and methacrylate resin-based materials during intra-oral repair of damaged restorations.

EAZY PRIMER™ is a two-part, self-cured dental primer which is used for enhancing the bond between dental ceramics (such as porcelain, lithium disilicate, zirconia, or hybrid ceramics) and methacrylate resin-based materials. The device is intended to be used to prepare surface treatments of restorations and repairs. The device comprises both a silane-coupling agent and a phosphate-coupling agent which generate significant bond strengths between dental ceramic surfaces and methacrylate resin-based materials. The device is packaged in two 5-milliliter bottles ("bottle A" and "bottle B"), which will be mixed in a 1:1 ratio just prior to use.

The document discusses the EAZY PRIMER™, a two-part, self-cured dental primer. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices rather than describing a study with acceptance criteria and device performance in the context of diagnostic accuracy, which is common for AI-driven medical devices.

However, based on the information provided, I can extract and infer details related to the device's performance through Shear Bond Strength tests, which serve as a measure of its effectiveness in enhancing bonding.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The acceptance criteria for the EAZY PRIMER™ are the Shear Bond Strengths, which are set at ">10MPa" for bonding to various dental ceramics. The reported performance of the device meets these criteria.

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

The document explicitly states that "Shear Bond Strength tests were performed in accordance with ISO/TS 11405." However, it does not specify the sample size used for these tests nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. For a physical materials test like Shear Bond Strength, the "ground truth" is typically established by the standardized testing methodology itself, rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective physical measurements rather than subjective interpretations 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:

This is not applicable. The device is a dental primer used for enhancing bonding, not an AI-driven diagnostic or interpretative tool that would involve human readers.

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

This is not applicable as the device is a chemical dental product, not an algorithm. The "standalone" performance here refers to the physical properties of the primer itself, which were tested according to ISO/TS 11405.

7. The type of ground truth used:

The ground truth used for evaluating the EAZY PRIMER™ is based on standardized physical property measurements, specifically "Shear Bond Strength" tests performed in accordance with ISO/TS 11405. This is an objective measurement of a material's adhesive strength, not an expert consensus, pathology, or outcomes data in the typical sense of medical device evaluations.

8. The sample size for the training set:

The concept of a "training set" is not applicable to this type of medical device (a chemical primer) evaluation. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reason as point 8.

In summary:

The provided document describes the regulatory approval of a dental primer based on its physical properties (Shear Bond Strength) meeting established criteria. The evaluation framework is specific to material science rather than diagnostic imaging or AI-driven tools, hence many of the requested categories (like "experts," "adjudication," "MRMC," "training set") are not relevant or not detailed in this context.

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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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