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1. Pit & Fissure Sealant and Root Surface Sealant
2. Hypersensitivity due to abrasion and early non-cavitated lesions
3. Protection immature enamel
4. Temporary filling including endodontic access

GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.

The provided document is a 510(k) summary for the GC Fuji Triage EP dental cement. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information typically found in a clinical study report that would outline acceptance criteria, study design, and results for a medical device with an algorithmic component.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they are not present in the provided text. The document describes a non-clinical performance testing for a dental cement, not a study involving human readers or AI algorithms.

Here's why each point of your request cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance: While there is a table of "Property" and "Requirements" for non-clinical performance (e.g., Net setting time, Compressive strength), this is for the physical properties of the dental cement, not the performance of an AI device. The document explicitly states "No clinical testing has been performed on this device."
2. Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no test set for an AI device, and thus no ground truth established by experts in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was performed as this is a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. The ground truth for the dental cement is based on laboratory-measured physical properties against ISO standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

The document pertains to the regulatory submission for a dental cement, GC Fuji Triage EP, and focuses on demonstrating its safety and efficacy through biocompatibility testing (ISO 10993-1:2018, ISO 10993-5, ISO 10993-10) and physical property testing against ISO 9917-1:2007 for water-based cements, as well as comparison to a predicate device for substantial equivalence.

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