(23 days)
Alexander alloy intended to be used for inlays, onlays, ¾ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns, and partial dentures.
Alexander
This is a 510(k) premarket notification for a dental alloy, not a medical device that utilizes AI or requires outcome-based studies. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics are not applicable in this context.
Here's a breakdown based on the provided document and the nature of the device:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way one would for a performance-based medical device (e.g., sensitivity, specificity, accuracy). Instead, for materials like dental alloys, the regulatory acceptance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing material properties, intended use, and other characteristics to ensure similar safety and effectiveness.
The "reported device performance" is not quantified in terms of clinical outcomes or diagnostic metrics in this document. The letter indicates that the device, "Alexander," is an alloy intended for various dental restorations (inlays, onlays, crowns, bridges, partial dentures). The performance is implicitly deemed acceptable by the FDA's "substantial equivalence determination."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a material submission, not a study evaluating a device's performance on patient data. The "test set" would refer to the characteristics and properties of the material itself, which would be measured and compared to the predicate, not a dataset of patient cases.
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. There is no concept of "ground truth" established by experts in the context of evaluating a dental alloy for substantial equivalence. The evaluation relies on material specifications and comparison to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which is not the case for a dental alloy submission.
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 device is a dental alloy, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for a dental alloy submission relates to its material composition, physical properties, and biocompatibility, which are verified through standard laboratory tests and comparison to a predicate, not through expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
Not applicable. This device is a dental alloy. There is no "training set" as understood in machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device.
In summary:
The provided document is a 510(k) clearance letter for a dental alloy. The regulatory process for such devices focuses on demonstrating substantial equivalence to a predicate device based on material properties, intended use, and basic safety/performance characteristics. It does not involve the types of clinical studies, AI algorithms, or expert ground truth adjudication described in your request.
§ 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.