(68 days)
Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental casting alloy, not a study evaluating an AI-enabled medical device. Therefore, it does not contain information related to acceptance criteria, study methodologies, or AI performance metrics as requested in the prompt.
Specifically, the document establishes the substantial equivalence of the "PD Casta-H" device to legally marketed predicate devices, allowing it to be marketed. This process does not involve the type of performance evaluation, ground truth establishment, or statistical analysis typically associated with AI device studies.
Therefore, I cannot provide the requested information based on the given document.
§ 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.