(118 days)
Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid. It is used to: - repair and rebase prosthesis - temporary prosthesis -
Major.repair is a cold-curing polymer for dental prosthesis. For reparing and rebasing dentures. Powder and liquid. It can be used to: - repair and rebase prosthesis . - temporary prosthesis . Major.repair is a self-curing polymer composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Here's a breakdown of the acceptance criteria and the study information for the major.repair device, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for major.repair are implicitly derived from the ISO 1567:1999 standard for "Dentistry – Polymer-based restorative materials," as the device is stated to comply with this standard. The reported performance data points from the NIOM Laboratory (Norway) are presented as direct measurements against relevant physical properties.
| Acceptance Criteria (Derived from ISO 1567:1999 Compliance) | Reported Device Performance (major.repair) |
|---|---|
| Flexural strength: (ISO 1567:1999 standard value) | 66.4 MPa |
| Flexural modulus: (ISO 1567:1999 standard value) | 2217 MPa |
| Water absorption: (ISO 1567:1999 standard value) | 21.2 µg/mm³ |
| Water solubility: (ISO 1567:1999 standard value) | 1.4 µg/mm³ |
| Residual monomer: (ISO 1567:1999 standard value) | 4.0 % |
Note: The exact numerical acceptance values from ISO 1567:1999 are not explicitly stated in the document, but the fact that the device complies with the standard implies its performance meets or exceeds those values. The reported performance data for major.repair are the values determined from testing.
Study Information
The 510(k) summary for major.repair does not describe a new, standalone clinical study or comparative effectiveness study in the traditional sense, but rather relies on a literature review and historical data.
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Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of a new, standalone study. The "test set" here refers to the samples used in the physical properties testing, but the sample size for those tests is not specified.
- Data provenance: For the physical properties data, the testing was performed by NIOM Laboratory – Norway. For clinical aspects, the provenance is a vast body of existing dental literature, clinical experience with similar products, and the manufacturer's own historical sales data since 1966. This is a retrospective approach based on existing information and general scientific acceptance.
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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 as the "ground truth" for the physical properties was established through standardized laboratory testing (NIOM). For the broader clinical "ground truth," it relies on the consensus and findings published in the extensive dental literature cited (e.g., McKabe, Phillips, Graig, O' Brien) and decades of clinical experience. No specific individual experts are identified as establishing a ground truth for a new test set.
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Adjudication method for the test set:
- Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the nature of the evidence provided for this dental material.
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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:
- No MRMC comparative effectiveness study was mentioned or performed. This device is a dental material, not an AI-assisted diagnostic or treatment planning tool.
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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 algorithm or AI device. The physical property tests are standalone measurements of the material itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical properties: Standardized laboratory measurements and compliance with ISO 1567:1999.
- For clinical safety and effectiveness: Broad expert consensus from extensive dental literature, historical clinical experience with similar product types, and the manufacturer's long-term sales history with no reported adverse effects. This is a combination of expert consensus derived from literature and real-world outcomes data over a long period.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm. The product's formulation and performance are based on established dental science and manufacturing processes.
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How the ground truth for the training set was established:
- Not applicable due to the absence of a "training set." The understanding of the material's properties and clinical behavior is derived from scientific principles, material characterization, and historical data as described above.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.