(60 days)
The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.
TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.
This FDA 510(k) clearance letter is for TempFIT Temporary Crown and Bridge Resin. It addresses the substantial equivalence of this device to a legally marketed predicate device (Luxatemp Ultra/Star, K101710).
However, this document does not describe the kind of AI/ML device study that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and the use of expert readers for ground truth establishment. Instead, it focuses on the equivalence of a dental biomaterial product based on its physical, chemical, and biological properties.
Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document describes a non-clinical testing approach for a dental material.
Here's how I can address your request based on the provided text, while highlighting the limitations:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Dental Material):
| Acceptance Criteria (Physical Properties) | Reported Device Performance (TempFIT Temporary Crown and Bridge Resin) |
|---|---|
| Appearance: Visual inspection shows no foreign impurities in the paste. | Passed: Visual inspection shows no foreign impurities in the paste. |
| Colour: The colours of the material show no more than a slight difference with the colour indicated by the manufacturer. | Passed: The colours of the material show no more than a slight difference with the colour indicated by the manufacturer. |
| Working time: ≥50s | Passed: ≥50s |
| Setting time: ≤10min | Passed: ≤10min |
| Surface finish: A test specimen polished has a glossy surface. | Passed: A test specimen polished has a glossy surface. |
| Flexural strength: ≥50MPa | Passed: ≥50MPa |
| Water sorption: ≤40μm/mm³ | Passed: ≤40μm/mm³ |
| Solubility: ≤7.5μm/mm³ | Passed: ≤7.5μm/mm³ |
Study Details (Non-Clinical for a Dental Material):
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Sample size used for the test set and the data provenance:
- The document mentions "test results demonstrated the qualification and substantial equivalence." However, it does not specify the sample sizes of the materials tested for each physical property.
- Data Provenance: The tests were performed according to ISO 10477 and Internal standard SOP of the company (HUGE SOP). Given the submitter's location (Rizhao City, China), the testing was likely conducted in China. The study is a non-clinical, laboratory-based performance test, not involving patient data.
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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 in this context. The "ground truth" for chemical and physical properties are established through standardized laboratory measurement techniques as per ISO standards and the company's internal SOPs, not through expert human interpretation in the way AI/ML ground truth is established.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical material test, not a subjective human-reading assessment.
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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. This type of study is relevant for AI-assisted diagnostic devices. This submission concerns a dental biomaterial.
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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-based device.
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The type of ground truth used:
- The "ground truth" for the physical and chemical properties of the temporary crown and bridge resin are the established measurement protocols and thresholds defined by ISO 10477 and the company's internal SOPs. These are objective, quantitative measurements (e.g., MPa for flexural strength, µm/mm³ for water sorption).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "development" of the material would involve chemical formulation and iterative testing, but not a "training set" in the computational sense.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary, the provided FDA clearance letter demonstrates a material's safety and effectiveness through adherence to established material standards and comparison to a predicate device, rather than through an AI/ML performance study.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.