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DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries.

DMC Composite 2 Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal buildups in non-stress bearing areas, incisal abrasions, small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.

DMC Composite 2 is a self-adhesive, light cured resin based composite dental restorative designed for direct placement. DMC Composite 2 is offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.

The provided document is a 510(k) summary for a dental composite restorative material, DMC Composite 2. It describes the device, its intended use, and claims substantial equivalence to predicate devices. It explicitly states that no clinical testing was performed for this product. Therefore, the device doesn't have "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial demonstrating performance metrics against set thresholds.

Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices based on similar technological/performance characteristics. The document focuses on regulatory approval rather than a detailed performance study with acceptance criteria.

However, I can extract the relevant information based on the premise of substantial equivalence as the "proof" the device meets regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical performance study was conducted, there are no specific quantitative acceptance criteria or reported device performance metrics in the document. The "acceptance criteria" here are implicitly being met by demonstrating substantial equivalence to predicate devices, which are already approved and presumed safe and effective.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. No clinical test set was used. The submission relies on non-clinical data and comparison to predicate devices.
• Data Provenance: Not applicable for a test set. The data provenance for the claim of substantial equivalence is based on the characteristics of the predicate devices which are legally marketed in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical test set with expert-established ground truth was used.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used.

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 device is a dental restorative material, not an AI-assisted diagnostic or treatment planning tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• Not applicable in the context of a performance study. The "ground truth" for the regulatory submission is the established safety and effectiveness of the legally marketed predicate devices to which DMC Composite 2 claims substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This device is not an AI/ML algorithm and does not have a training set or associated ground truth.

Summary based on the provided document:

The regulatory approval for DMC Composite 2 is based on non-clinical test data and a claim of substantial equivalence to existing legally marketed dental composite restorative materials (Predicate Devices: Premise, Premise Flowable, Optibond Solo Plus 2). The document explicitly states: "Clinical testing has not been conducted on this product." The rationale is that the "addition of the new indications would not result in any formula changes to DMC Composite 2, there is no reason to suspect that the safety and biocompatibility of DMC Composite 2 would be adversely affected." Therefore, the "study" proving the device meets criteria is essentially the analysis of its formulation and intended use in comparison to known, approved devices, without new clinical trials.

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DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.

DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental composite material, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the FDA's decision regarding its market clearance. It does not include details about specific performance studies or acceptance criteria that would typically be found in a clinical trial report or a detailed performance testing document.

Ask a specific question about this device