(51 days)
PlatinLloyd 100 is : crown and bridge type 4 casting alloy. It is a medical device in PlatinLloyd 100 is ? Crown and online components to Annex IX. The CE seal accordance with Regulation 93/42 EEC. Class IIa according to Annex IX. The CE seal accordance with Regulation 75/42 BEO. Class and were and
Not Found
"1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) clearance letter for a medical device (PlatinLloyd 100) and an 'Indications For Use' statement. It does not contain information about acceptance criteria or a study demonstrating device performance. The letter simply states the device is substantially equivalent to legally marketed predicate devices.",
"2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)": "This information is not available in the provided document.",
"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)": "This information is not available in the provided document. The submission is a 510(k) for a casting alloy, not an AI or diagnostic device that typically involves expert ground truth for performance evaluation.",
"4. Adjudication method (e.g., 2+1, 3+1, none) for the test set": "This information is not available in the provided document.",
"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": "This information is not available in the provided document. The device is a casting alloy, not an AI-powered diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done": "This information is not available in the provided document. The device is a casting alloy, not an AI or algorithmic device.",
"7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)": "This information is not available in the provided document.",
"8. The sample size for the training set": "This information is not available in the provided document. The submission is for a casting alloy, which typically doesn't involve training sets in the AI sense.",
"9. How the ground truth for the training set was established": "This information is not available in the provided document."
}
§ 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.