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Fabrication of temporary crowns, bridges, inlays, onlays, and veneers
Fabrication of long-lasting temporary restorations .
. Lining material for prefabricated temporary crowns made of composite (e.g., ProtempTM Crown) and metal (e.g., Iso-Form crowns)

SuPro 100 is classified as temporary crown and bridge resin (21 C.F.R. § 872.3770, Class II device). As its predicate device TempXN28 (K073296, by 3M Deutschland GmbH - Germany), SuPro 100 is a composite material based on multifunctional methacrylates esters, therefore, both TempXN28 and SuPro 100 as two-component system have filling material-like properties. As TempXN28, Supro 100 will be available in Garant™ mixing and dispensing system (by 3M Deutschland GmbH, Germany).

This is a 510(k) summary for a dental temporary restorative material, SuPro 100. The document focuses on demonstrating substantial equivalence to a predicate device (TempXN28) rather than providing detailed acceptance criteria and a study report in the format typically seen for AI/ML-driven medical devices.

Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this type of regulatory submission because it is for a physical dental material, not a software device or AI algorithm.

However, I can extract the acceptance criteria (in terms of performance comparisons) and summarize the "study" (i.e., the physical and mechanical testing performed).

Acceptance Criteria and Device Performance for SuPro 100

The acceptance criteria for SuPro 100 are based on demonstrating "substantial equivalence" to the predicate device, TempXN28 (K073296), in terms of physical and mechanical properties, as well as biocompatibility and indications for use. The "study" refers to the series of laboratory tests conducted on SuPro 100 and TempXN28 to compare their performance.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of "Acceptance Criteria" for Substantial Equivalence:
The implied acceptance criterion is that SuPro 100 must either demonstrate comparable performance or, ideally, superior performance in key mechanical and physical properties while maintaining similar handling characteristics (like setting time within a functional range), biocompatibility, and intended uses as the predicate device. For several key mechanical properties (flexural strength, e-Modulus, tensile strength, surface hardness), SuPro 100 showed higher values, which is considered an improvement. For other properties, it was "comparable" or "similar." Faster setting time is a characteristic difference. Lower compression strength and compression at break were noted, but the overall conclusion was still substantial equivalence, likely because other reinforcing properties were improved.

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

• Sample Size: Not explicitly stated in the 510(k) summary. For physical and mechanical tests of materials, established dental material standards (e.g., ISO) typically specify minimum sample sizes for each test type (e.g., n=5 or n=10 per group). Given the reference to ISO standards, it is highly likely that suitable sample sizes were used in accordance with those standards.
• Data Provenance: The tests were conducted by 3M Deutschland GmbH in Germany. This is a prospective testing of the manufactured material.

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

• Not Applicable. This is a material testing submission, not a diagnostic device involving expert interpretation of data or images. The "ground truth" for material properties is established through standardized laboratory measurements and physical tests referencing ISO standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Objective Material Property Measurements: The "ground truth" for the performance comparisons comes from direct laboratory measurements of physical, mechanical, and chemical properties of the material, as defined by international standards (e.g., ISO 179-1, ISO 527-1, ISO 4049, ISO 9917 for physical/mechanical; ISO 7405, ISO 10993 series for biocompatibility).

8. The sample size for the training set:

• Not Applicable. This is a physical material, not an AI/ML model. There is no concept of a "training set" in this context. The formulation of the material and its properties are developed through R&D (research and development) processes.

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

• Not Applicable. See point 8. The "ground truth" for material development is based on scientific principles of polymer chemistry and material science to achieve desired properties.

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