(31 days)
Monopaque is intended to be used for masking exposed metal in increasing of defective ceramic and composite veneers.
Not Found
The provided document is a 510(k) premarket notification approval letter for a dental device called "Monopaque." This type of document from the FDA primarily focuses on establishing substantial equivalence to a predicate device, rather than detailing the full acceptance criteria and performance study outcomes that would be found in a clinical trial report or a comprehensive device submission.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices..." This signifies that the FDA's decision is based on a comparison to existing devices, not necessarily on a new, comprehensive performance study with specific acceptance criteria as you've outlined.
The "Indications For Use" section on page 2 simply states: "Monopaque is intended to be used for masking exposed metal of defective ceramic and composite veneers." This describes the device's purpose, but not its performance metrics or acceptance criteria.
To obtain the information you're looking for, you would generally need to refer to the full 510(k) submission document itself (which is often publicly available, but not part of this letter) or, in some cases, clinical study reports referenced within such a submission.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.