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• Temporary anterior and posterior crowns with a wearing time of maximum three years
• Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
• Verifying the fit on the plaster model/mouth before the final restoration

Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.

Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.

Here's a breakdown of the acceptance criteria and study information for the Ceramill A-Temp device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details:

This submission describes non-clinical performance testing to demonstrate the safety and effectiveness of the Ceramill A-Temp and its substantial equivalence to a predicate device (K112967, PMMA CAD/CAM Disc).

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

   • The document does not specify exact sample sizes for each individual non-clinical test (e.g., how many samples were used for bending strength testing).
   • The data provenance is from non-clinical laboratory testing performed by Amann Girrbach AG. The country of origin of the testing is not explicitly stated but implies testing by the manufacturer (Amann Girrbach AG, based in Austria) or a contracted lab. It is retrospective in the sense that the testing was completed prior to the 510(k) submission.

2. 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):

   • No human "experts" in the sense of clinical decision-making were involved in establishing ground truth for these non-clinical tests. The "ground truth" for these tests is defined by international and national standards (e.g., ISO 10477:2018, ISO 10993-1) and internal requirements. Scientific and engineering experts set these standards.

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

   • Not applicable as this is non-clinical performance testing against pre-defined engineering and material standards, not a clinical trial requiring human adjudication of results.

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:

   • No, an MRMC comparative effectiveness study was not performed. This device is a dental material (temporary crown and bridge resin) and does not involve AI or human "readers" in its application.

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

   • No. This is a material device, not an algorithm, so this concept is not applicable.

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

   • The "ground truth" or reference standard for this non-clinical testing is based on International and National Standards (specifically ISO 10477:2018 for dental polymer-based materials and ISO 10993-1 for biocompatibility) and internal material specifications.

7. The sample size for the training set:

   • This concept is not applicable. This is a physical dental material, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not applicable.

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