(147 days)
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.
| Acceptance Criteria (Shear Bond Strength) | EAZY PRIMER™ Reported Performance |
|---|---|
| Shear Bond Strength to Porcelain (>10MPa) | >10MPa |
| Shear Bond Strength to Lithium Disilicate (>10MPa) | >10MPa |
| Shear Bond Strength to Zirconia (>10MPa) | >10MPa |
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.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.