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The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.

TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.

TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.

Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges

The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.

The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.

The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.

The provided text describes a 510(k) premarket notification for dental polymer blanks. This type of document is for demonstrating substantial equivalence to a predicate device, not for describing the acceptance criteria and study proving a device meets them for a novel AI/software product. Therefore, much of the requested information regarding AI/software performance studies is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the performance relative to a standard for the physical properties of these dental devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject devices are based on their compliance with the International Standard ISO 10477:2004 for polymer-based dental restorative materials. The reported device performance is presented as the measured values for flexural strength, water absorption, and water solubility.

Study Details (based on the provided text):

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

   • The document states "All tested samples correspond with the requirements of the standard" for physical properties. It does not specify the exact sample size for each test.
   • Data provenance is not explicitly stated as country of origin, but the applicant's address is in Italy. The tests were performed according to international standards (ISO).
   • The study is a non-clinical, in-vitro laboratory testing study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical, physical and biocompatibility testing study against ISO standards, not an AI/software performance study requiring expert ground truth for interpretation of images or clinical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. See point 2.

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 document does not describe a MRMC study or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes physical and biocompatibility testing of dental materials, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests were the physical and chemical requirements defined by the ISO 10477:2004 standard and the biological evaluation principles of ISO 10993-1.

7. The sample size for the training set: Not applicable. There is no AI/machine learning model to train.

8. How the ground truth for the training set was established: Not applicable. There is no AI/machine learning model to train.

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