(95 days)
Biocryl X is intended for the laboratory fabrication of radiographic templates to be worn by a patient during x-ray imaging.
Biocryl X is indicated for the fabrication of dental radiographic templates worn during x-ray imaging.
Biocryl X is a radiopaque, auto-polymerizing powder/liquid dental acrylic system.
The provided text describes a 510(k) submission for a dental acrylic system named "Biocryl X." This submission focuses on establishing substantial equivalence to a predicate device, not on demonstrating clinical performance against specific acceptance criteria in a study involving human or image-based diagnostics.
Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and AI-related studies is not applicable to this document.
However, I can extract the relevant information regarding the tests performed to establish equivalence:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Reporting Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical properties | Evaluated | Comparable to predicate device (implied) | Supports safety and effectiveness |
| Hardness | Evaluated | Comparable to predicate device (implied) | Supports safety and effectiveness |
| Exotherm | Evaluated | Comparable to predicate device (implied) | Supports safety and effectiveness |
| Water absorption and extractables | Evaluated | Comparable to predicate device (implied) | Supports safety and effectiveness |
| Working times | Evaluated | Comparable to predicate device (implied) | Supports safety and effectiveness |
| Agar Diffusion Assay (Biocompatibility) | Determined | Non-cytotoxic | Non-cytotoxic |
| Mucous Membrane Irritation (Biocompatibility) | Determined | Non-irritant | Non-irritant |
| Klingman Maximization Test (Biocompatibility) | Determined | Non-sensitizer | Non-sensitizer |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the tests.
- The data provenance is not explicitly stated. These are laboratory/material tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "ground truth" here refers to the results of standardized material and biocompatibility tests, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. These are objective laboratory tests, not subjective assessments 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
- Not applicable. This is a material science 510(k) submission, not a study of AI-assisted diagnostic effectiveness.
6. 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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the tests performed is the objective outcome of standardized material property and biocompatibility assays (e.g., whether a material is cytotoxic, its hardness value).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.