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The NobelProcera IPS e.max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.

NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.

The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.

The provided text describes a 510(k) premarket notification for a dental device, the NobelProcera IPS e.max Crown. It does not contain information about a study with acceptance criteria and reported device performance in the context of AI/ML or diagnostic performance. Instead, it focuses on the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence for regulatory approval.

Here's a breakdown based on the information provided and what is missing regarding the requested criteria:

1. A table of acceptance criteria and the reported device performance

• Missing. The document does not describe specific numerical acceptance criteria or performance metrics for diagnostic accuracy, sensitivity, specificity, or similar measures typically found in performance studies for AI/ML devices. The "performance" mentioned refers to mechanical testing of the material.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Missing. No test set, clinical data, or patient data (retrospective or prospective) is described for evaluating the device's diagnostic or clinical performance in the context of your typical AI/ML study. The determination of safety and effectiveness was based on "Non-clinical test data," which refers to mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Missing. This information is not applicable as no test set requiring expert ground truth or diagnostic assessment is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Missing. Not applicable, as no test set requiring expert adjudication is mentioned.

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

• Missing. No MRMC study or AI assistance is mentioned. This device is a physical dental crown, not an AI/ML diagnostic tool for which such studies would be relevant.

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

• Missing. Not applicable, as this is a physical dental device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Instead of "ground truth" for a diagnostic task, the "truth" for this device's safety and effectiveness was established through non-clinical mechanical testing (e.g., aging, biaxial, static, and dynamic load tests) of the material. The conclusion hinges on demonstrating its mechanical properties are comparable to or better than predicate devices.

8. The sample size for the training set

• Missing. Not applicable, as this is a physical device and no AI/ML model or training set is involved.

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

• Missing. Not applicable, as no training set or AI/ML model is involved.

Summary of Device Acceptance and Study:

The NobelProcera IPS e.max Crown is a physical dental device (core superstructure for crowns) and its "acceptance" for regulatory purposes (510(k) clearance) was based on demonstrating substantial equivalence to existing legally marketed predicate devices (Procera Copings and Pontic, IPS e.max CAD/IPS e.max Zircad).

The "study" that proves the device meets the acceptance criteria (i.e., is safe and effective for its intended use) was non-clinical mechanical testing of the e.max material. These tests included aging, biaxial (ISO 6872), static, and dynamic load tests. The objective was to confirm the material's strength to withstand anticipated mastication forces. The document explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness."

No clinical trials, human reader studies, or AI/ML performance evaluations were conducted or are relevant for this type of device and regulatory submission.

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