(132 days)
Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequated by working framework.
Solidex is a light cured, hard crown and bridge composite.
The provided document is a 510(k) premarket notification letter from the FDA for a dental material called "Solidex." This document does not describe a study or acceptance criteria for a medical device that utilizes AI or other algorithmic performance metrics.
Instead, it's a regulatory clearance for a traditional dental cement. Therefore, I cannot extract the information requested as it is not present in the provided text.
The questions in your prompt (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are specific to the evaluation of AI/ML-based medical devices or diagnostic tools. "Solidex" is a material, not a diagnostic or AI-driven device, so these types of evaluations are not applicable or described in this 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.