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• Fabrication of permanent & temporary indirect restorations
• Crowns & Bridges for anterior and posterior restorations
• Jacket crowns for anterior and posterior restorations
• Inlays & Onlays
• Laminate veneers
• Implant superstructures
• Intraoral & extraoral repairs of indirect restorations

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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Ceramage Up". This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device validation. It solely confirms the substantial equivalence of the "Ceramage Up" device to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant for AI/machine learning medical devices, which require specific studies to prove their performance. This document is for a dental material (Tooth Shade Resin Material), not an AI device.

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Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.

CERAMAGE is intended for use for following:

• Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and posterior, inlays, onlays, laminate vehove and upper structure of implants.
• Used for extra/intra-oral repair of crown restorations and defect prosthetic restorations.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental material called "Ceramage." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is related to a medical device approval, not an AI/algorithm-based diagnostic tool.

Therefore, I cannot provide the requested information based on the input document. The questions you've asked (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are highly relevant to the evaluation of AI/ML-based medical devices, but not to the approval of a dental resin material like Ceramage.

Here's why the questions don't apply to the provided document:

• Ceramage is a physical dental material (resin), not an AI/ML algorithm or diagnostic device. Its approval relies on demonstrating substantial equivalence to existing predicate devices based on material properties, biocompatibility, and intended use, not on performance metrics like sensitivity, specificity, or AUC against a ground truth.
• The document is a 510(k) clearance letter, not a study report or clinical trial summary. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval.
• Concepts like "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC comparative effectiveness studies" are specific to the validation of diagnostic algorithms or software. They are not applicable to the assessment of a composite resin material.

If you have a document related to an AI/ML medical device, I would be happy to analyze it for the requested information.

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