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Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

Embrace™ Dual Cure Composite Materials are used to permanently cement dental posts, porcelain crowns, inlays, onlays, bridges, porcelain/laminate veneers and periodontal splints, to repair porcelain crowns intra-orally and as a build-up and repair material.

Embrace™ Dual Cure Composite Materials are multi-purpose, hydrophilic, fluoride-releasing, resin-based materials that contain no Bisphenol A and bond tightly to dentition.

The provided text is a 510(k) premarket notification for a dental material (PULPDENT EMBRACE™ DUAL CURE COMPOSITE MATERIALS). This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting a de novo study with acceptance criteria and performance data in the way an AI/ML device would.

Therefore, the document does not contain the information requested in your numbered list, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or details on training sets.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Multi-reader multi-case comparative effectiveness studies.
5. Standalone algorithm performance.
6. Specific ground truth types.

Instead, the document states:

• "PULPDENT DUAL CURE COMPOSITE MATERIALS are substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
• It refers to predicate devices that have "been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices."
• It cites a general statement from an NIH Technology Assessment Conference regarding the high benefit-to-risk ratio and safety of dental restorative materials over time.

In summary, this document describes a regulatory pathway based on substantial equivalence to predicate devices for a dental material, not a de novo study with performance metrics as typically seen for AI/ML device evaluations.

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