(64 days)
x-tra base:
- Base in class I and II cavities
- Cavity lining under direct restorative materials in class I and II cavities
Not Found
This is an FDA Premarket Notification (510(k)) letter for a dental device called "X-tra Base". This document signifies clearance for the device to be marketed, based on its substantial equivalence to previously approved predicate devices.
However, the provided text does not contain any information about acceptance criteria, study design, or performance metrics that would be necessary to answer your detailed questions about a study proving the device meets acceptance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would then be reported in the clearance letter itself.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA found the device to be as safe and effective as a device already on the market, not that a new study with the specific criteria you're asking about was conducted and then summarized here.
Therefore, I cannot provide the requested table or detailed information on the study (sample size, experts, adjudication, MRMC, standalone, ground truth, training set details) because that information is not present in the provided document.
§ 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.