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BisCem GI is a dual-cure radiopaque dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and uses are identical.

1. Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
2. Luting resin crowns, bridges, inlays, onlays and veneers;
3. Luting metal or non-metal posts;
4. Luting orthodontic appliances;
5. Luting porcelain inlays.

BisCem GI is a dual-cured resin modified glass ionomer cement. It is a self-adhesion cement bonding to composite, metal, silanated porcelain and tooth structure without applying any adhesive. For bonding to dentin and enamel, no etching step is required. With its dual syringe system, BisCem GI can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly.

This is a 510(k) summary for a dental luting cement, BisCem GI. It is a submission to demonstrate substantial equivalence to a predicate device, GC FujiCem. In such submissions, the acceptance criteria relates to the equivalence of physical properties and intended uses compared to the predicate device, rather than a clinical study with specific performance metrics like sensitivity/specificity for diagnostic AI devices.

Here's an analysis based on the provided text, structured according to your request, but acknowledging the nature of this particular device and submission type:

Acceptance Criteria and Device Performance (Based on 510(k) Summary for BisCem GI)

Given that this is a 510(k) submission for a dental luting cement, the "acceptance criteria" is primarily the demonstration of "substantial equivalence" to a legally marketed predicate device (GC FujiCem) in terms of intended use, chemical composition, and mechanical/physical properties. Performance here refers to these comparative characteristics rather than statistical metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "Side by side comparisons of BisCem GI to the predicate device GC FujiCem clearly demonstrates that the applicant device is substantially equivalent to the legally marked devices."

This indicates that a comparative study was performed to assess the physical and chemical characteristics of BisCem GI against GC FujiCem. The specific methodology for these comparisons (e.g., standardized testing protocols for viscosity, bond strength, wear resistance, etc.) is not detailed in this summary.

Regarding the specific points requested for AI/Diagnostic Device Studies:

The provided document describes a 510(k) submission for a dental material (luting cement), not an AI algorithm or a diagnostic device. Therefore, many of the requested points related to AI/diagnostic study design are not applicable to this type of submission.

2. Sample size used for the test set and the data provenance: Not applicable for this type of device. The "test set" would refer to material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a luting cement relates to its physical/chemical properties, established through laboratory testing rather than expert-labeled data.
4. Adjudication method for the test set: Not applicable. Material properties are measured, not adjudicated.
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. This is not an AI 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.
7. The type of ground truth used: For a dental luting cement, the "ground truth" for proving substantial equivalence involves established scientific methods and standards for measuring material properties (e.g., bond strength, setting time, solubility, compressive strength, biocompatibility according to ISO standards). The document mentions "biocompatibility" testing, concluding it was "non-toxic."
8. The sample size for the training set: Not applicable (no "training set" for physical material properties).
9. How the ground truth for the training set was established: Not applicable (no "training set" in this context).

Summary of Device and Acceptance:

BisCem GI is a dual-cured resin modified glass ionomer cement. Its intended use is as a luting cement for various dental restorations (metal/resin crowns, bridges, inlays, onlays, veneers, posts, orthodontic appliances, porcelain inlays).

The device met the acceptance criteria for substantial equivalence to its predicate device, GC FujiCem, by demonstrating similar intended uses, comparable chemical composition (with an additional dual-cure feature), and similar mechanical/physical properties (low viscosity, dispensable composite), as well as being found non-toxic in biocompatibility testing. The submission concludes that this information proves the safety and efficacy of BisCem GI, leading to its clearance by the FDA.

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