(15 days)
Reconstruction of porcelain-to-metal dental restorations.
Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implant-supported prosthesis substructures.
The provided text describes a 510(k) submission for dental gold alloys (Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82) and aims to demonstrate their substantial equivalence to a predicate device, Bioherador SG, Herador S.
However, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through empirical measurements or AI model evaluations. Instead, it focuses on the regulatory submission process for a medical device.
The document states:
- "Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82 have the same device characteristics as the predicate device. Material, design and use concept is similar."
- "Apex93, Apex87, Apex84, Apex77, e-Sarang 88, e-Sarang 82 have been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
- "An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted."
These statements indicate that the submission relies on the established safety and performance of the predicate device, general industry standards, and a literature review, rather than a specific, new study with defined acceptance criteria and performance metrics for the submitted devices. The "validations prior to release" are mentioned but no specifics about these validations, their acceptance criteria, or their results are provided in the text.
Therefore, many of the requested items related to a study proving acceptance criteria cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, biocompatibility thresholds) with numerical targets, nor does it present a table of measured performance data for the submitted devices against such criteria. It generally states that the devices have "the same device characteristics as the predicate device" and have passed "safety tests."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not detail any specific "test set" in the context of a performance study with a sample size. The safety and performance assessments are described broadly as "extensive safety, performance, and product validations" and "safety tests" without specifying sample sizes or data provenance.
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 / Cannot be provided. This question is relevant to studies involving expert review for establishing ground truth, typically for AI/imaging devices. As this is a materials submission for dental alloys, such a concept of "experts establishing ground truth for a test set" is not detailed or relevant in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. Similar to point 3, this is relevant to expert review processes, which are not described in the context of a performance study for these dental alloys.
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 / Cannot be provided. MRMC studies are specifically for evaluating diagnostic performance, often with AI assistance for human readers. This submission is for dental materials, not a diagnostic or AI-powered device, so an MRMC study is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Cannot be provided. This refers to standalone AI algorithm performance, which is not relevant to a dental alloy submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be provided. Ground truth is a concept for evaluating the accuracy of a diagnostic or predictive system. For dental alloys, the "truth" would be adherence to material specifications and biocompatibility standards, and these are stated as having been met through "validations" and "safety tests," but specific methodologies for defining "truth" for evaluation are not detailed.
8. The sample size for the training set
- Not applicable / Cannot be provided. A "training set" is used for machine learning algorithms. This submission is for dental materials, not an AI device.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As above, this is relevant to AI/machine learning, not dental materials.
In summary, the provided document is a regulatory submission for dental alloys, demonstrating substantial equivalence to a predicate device based on similar characteristics, broad safety/performance validations, and a literature review. It does not include the details of a specific study with acceptance criteria and performance data as requested.
§ 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.