(43 days)
Chroloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as removable partial dentures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Chroloy" and does not contain information about acceptance criteria, device performance, or any studies using AI. The document indicates that the device is a base metal alloy for dental prosthetics and has been found substantially equivalent to predicate devices. It does not describe any acceptance criteria or studies in the context of device performance metrics typically found in AI/ML medical device submissions.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information related to AI/ML device performance, ground truth, or expert involvement based on the provided text.
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.