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Indications:

• • Direct anterior restorations including:
    • Class III, IV, V, and VI 1
    • Veneers ー
    • Incisal edge repair -
• • Direct posterior restorations including:
    • Class I or II l
    • Sandwich technique with glass ionomer resin material l
    • -Cusp Buildups
• • Core Buildups
• ★ Splinting
• Indirect anterior and posterior restoration including: ★
  • -Inlays
  • Onlays -
  • Veneers

3M™ Dent II System is a visible-light activated, radiopaque restorative material. This device, as well as the predicate devices, are based on monomer chemistry.

The 3M™ Dent II System is a tooth shade resin material used for dental restorations. The provided 510(k) summary focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than establishing novel performance criteria through extensive clinical studies with specific acceptance criteria in the context of AI/software device evaluation. Therefore, many of the requested categories are not directly applicable or explicitly detailed in this type of submission for a physical dental material.

Here's an attempt to extract and infer information relevant to your request based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the 3M™ Dent II System are implicitly set by its performance being "as well or better than the predicate devices" across various physical and chemical properties. The study conducted to prove this involves bench tests comparing the new device against several predicate devices.

Study Details

The provided document describes a 510(k) submission, which primarily relies on bench testing to demonstrate substantial equivalence for a physical medical device (dental restorative material). It is not a clinical study involving human subjects or an AI/software device. Consequently, many of the requested categories related to AI/software evaluation (test set size, ground truth, experts, MRMC studies, standalone performance, training set) are not applicable or detailed in this context.

Here's an analysis based on the information available:

1. Sample size used for the test set and the data provenance: Not applicable in the context of "test set" for AI. The "tests" here refer to bench tests of material properties. The sample sizes for these physical property tests are not specified in this summary. The data provenance would be from 3M's internal laboratory, presumably in the USA. These are prospective tests conducted on manufactured samples of the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the AI sense does not apply to the physical properties being measured in bench tests. The measurements themselves (e.g., shrinkage, strength, hardness) are the "truth" derived from standardized testing methods.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling or diagnoses, which is not relevant for bench testing of material properties.

4. 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-assisted device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the bench tests, the "ground truth" is established by standardized laboratory measurement methods for physical and chemical properties (e.g., methods for measuring shrinkage, tensile strength, compressive strength, wear, hardness, depth of cure). These are objective measurements rather than subjective expert consensus or pathology.

7. The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

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