(35 days)
- Posterior restorative material for Class I, II and V, and composite core build-up.
PYRAMID is a condensable, highly filled (79% w/w), light-cured radiopague composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, PYRAMID is glass frit filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light initiators. Both devices are designed to be used with high quality dentin / enamel adhesive systems.
The provided text describes the predicate device "BISFIL™P" and the applicant device "PYRAMID™", both composite restorative materials. The submission focuses on demonstrating substantial equivalence, primarily through material properties tests rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set) are not applicable or cannot be extracted from the given text.
Here's an analysis of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (PYRAMID™) | Performance (Predicate Device: BISFIL™P) |
|---|---|---|
| Diametral Tensile Strength (DTS) | 51 MPa | 55 MPa |
| Biocompatibility | Non-toxic (Cytotoxicity per ISO 10993-5) | (Implied compliant as predicate) |
| Wear Resistance | "more wear resistance" (compared to general expectation for composites needing reinforcement) | "vastly improved abrasive resistance" |
| Tensile Strength | "higher tensile strength" (compared to general expectation for composites needing reinforcement) | "high tensile strength" |
| Compressive Strength | "higher compressive strength" (compared to general expectation for composites needing reinforcement) | "high compressive strength" |
| Radiopacity | Radiopaque | Radiopaque |
| Filler Content | 79% w/w | 86% w/w |
| Consistency/Handling | Condensable, similar to conventional amalgam | Condensable, similar to conventional amalgam |
Note on Acceptance Criteria: The document primarily states that PYRAMID's physical properties are "similar to the predicate device" and are designed to be "more wear resistance as well as higher tensile and compressive strength" (in a general sense of desirable properties for posterior composites). The only specific numerical acceptance criterion implied by direct comparison is the DTS value being close enough to the predicate to establish substantial equivalence.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the DTS test.
- Data Provenance: The document refers to "non-clinical tests" and standards like ISO 4049 and American Dental Association #27. Cytotoxicity testing was performed by a "commercial testing laboratory (NAMSA)". No country of origin for the data is explicitly mentioned beyond the US location of the applicant. The data is retrospective in the sense that the tests were performed on the materials after their development to demonstrate equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a materials property study, not a clinical study requiring expert ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Not a diagnostic study requiring adjudication.
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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 device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance described is for the material itself in laboratory settings.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the physical properties, the "ground truth" is the measured value from standardized non-clinical tests (e.g., DTS per ISO standards). For biocompatibility, it's the official report from the commercial testing laboratory based on ISO 10993-5.
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The sample size for the training set:
- Not applicable. This is a material, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable. This is a material, not a machine learning model.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.