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K Number
K050401
Device Name
CERAMAGE
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2005-04-28

(70 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.
Device Description

Not Found

AI/ML Overview

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.

§ 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.