(281 days)
Thermoforming sheet materials are indicated for the fabrication of orthodontic and dental appliances.
Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patients individual plaster models. After cooling the sheets are removed from the model and trimmed to fit.
The provided FDA 510(k) clearance document for "Thermoforming Sheet Materials" (K200125) describes non-clinical testing for biocompatibility and physical properties, but it does not contain information about a study involving acceptance criteria related to a device's performance that would require a test set, ground truth established by experts, or MRMC studies.
This submission is for a material (thermoforming sheets) used to fabricate orthodontic and dental appliances, not a diagnostic or AI-driven device. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted and a clear indication of what is not present in the document based on the device type:
1. A table of acceptance criteria and the reported device performance
The document provides a list of standards the materials were tested against, implying that meeting these standards constitutes the acceptance criteria. The reported performance is that the materials are in compliance with these standards for biocompatibility and that physical properties were tested.
| Acceptance Criteria (Implied by Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 (Biocompatibility) | Insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use. Biological effects considered for leachables (cytotoxicity, mucosa irritation, sensitization, acute systemic and subchronic toxicity, genotoxicity) were evaluated. |
| Compliance with Physical Property Standards (e.g., ISO 62/1 for water absorption, ISO 1183 for density, ISO 527 for tensile strength, etc.) | Physical properties have been tested according to the applicable standards (listed in the document). The document concludes that the proposed device has "the same performance specifications" as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the non-clinical tests.
- Data Provenance: Not specified. The company is based in Germany, so tests may have been conducted there or by a contract lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a material, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with established material science and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable.
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, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Adherence to established international and FDA-specific guidance documents and standards (EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350) which involve specific chemical and biological assays.
- For physical properties: Adherence to material testing standards (e.g., various ISO standards) which involve quantifiable measurements.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable.
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