(56 days)
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations.
The provided text describes a 510(k) submission for a dental alloy, AP-052-5. The submission focuses on demonstrating substantial equivalence to a predicate device (Helioform - K990670) based on mechanical, physical, and biocompatibility properties.
Unfortunately, the text does not contain any information about acceptance criteria or a study proving that a device (in the sense of a medical imaging or diagnostic AI device) meets those criteria.
Instead, the document is concerned with the regulatory clearance of a material (a dental alloy). Therefore, most of the requested points are not applicable to the provided context.
Here's a breakdown of why and what information is available:
- No "device performance" in the AI/diagnostic sense is reported. The "performance" described is the material properties of the alloy.
- No "study" in the sense of a clinical or image-based diagnostic study is mentioned. The "data" presented focuses on mechanical, physical, and biocompatibility properties.
- No ground truth, experts, adjudication, MRMC, or standalone performance studies are relevant or discussed. These concepts are specific to diagnostic or AI device evaluations.
Based on the provided text, the dental alloy AP-052-5:
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Acceptance Criteria for Approval (Implicit, inferred from the text):
- Mechanical properties demonstrating suitability for porcelain-fused-to-metal technique.
- Physical properties demonstrating suitability for porcelain-fused-to-metal technique.
- Biocompatibility according to International Standard ISO 10993-1.
- Substantial equivalence to the predicate device (Helioform - K990670) for these properties.
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How the "Device" (Alloy) Meets Criteria:
- "Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region."
- "Biocompatibility of AP-052-5 has been assesed according to International Standard ISO 10993-1."
- "The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device."
Summary of Requested Information vs. Available Information:
| Section of Request | Information from Text (AP-052-5 Dental Alloy) |
|---|---|
| 1. A table of acceptance criteria and the reported device performance | Acceptance Criteria (Implicit from 510(k) process): Substantial equivalence to predicate device in mechanical, physical, and biocompatibility properties for use in porcelain-fused-to-metal dental restorations. |
| Reported Performance: "Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed," and "Biocompatibility of AP-052-5 has been assesed according to International Standard ISO 10993-1." | |
| 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) | Not applicable. This pertains to clinical studies for performance evaluation, not material characterization. The text does not provide details on sample sizes for mechanical, physical, or biocompatibility testing, nor their provenance. |
| 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts | Not applicable. No ground truth in the sense of clinical diagnosis is established. Performance is based on material properties testing. |
| 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set | Not applicable. This pertains to expert review for clinical ground truth. |
| 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 (dental alloy) submission, not an AI or diagnostic imaging device. No human readers or AI assistance are involved. |
| 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done | Not applicable. This is a material (dental alloy) submission, not an AI or diagnostic imaging device. |
| 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc) | Not applicable in the clinical sense. Ground truth for a material is typically established by standardized laboratory testing (e.g., tensile strength, hardness, cytotoxicity tests) that yield measurable values, which are then compared to established standards or predicate device properties. The text mentions ISO 10993-1 for biocompatibility. |
| 8. The sample size for the training set | Not applicable. There is no "training set" as this is not an AI or machine learning device. |
| 9. How the ground truth for the training set was established | Not applicable. There is no "training set" as this is not an AI or machine learning device. |
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.