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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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PRETTAU® ANTERIOR T0 is intended to be used for the manufacturing of metal free single-unit anterior and posterior prostheses, inlays, onlays, veneers bonded dental restorations.

PRETTAU® ANTERIOR T0 is a millable dental ceramic material made of zirconia.

PRETTAU® ANTERIOR TO is destined for manufacture with CAD/CAM technology of metal free single-unit anterior and posterior prostheses, implant superstructures, inlays, onlays and veneers as fully anatomical restoration as well as for reduced structures for veneering with ceramics. The device is compatible with commercially available dental CAD/CAM systems must be validated by the user. The blocks are suitable for all milling units which are able to process presintered zirconia and which have the proper clamping device for the corresponding blank. PRETTAU® ANTERIOR TO is marketed in 25 different outer shapes, i.e. barrel, discs, rectangular, and special shapes; the blocks are produced in various heights from 10mm to 50 mm for each shape.

This document is a 510(k) Summary for the medical device PRETTAU® ANTERIOR T0, a millable dental ceramic material made of zirconia. It provides information about the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes used for the non-clinical tests (flexural strength, chemical solubility, fracture toughness, CTE, biocompatibility).
• Data Provenance: The tests were performed in support of regulatory submission, likely at the manufacturer's or a contracted lab. The document does not specify the country or whether the data is retrospective or prospective, but given it's for a new product, it would be prospective testing.

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

• This information is not applicable. The device is a material, and "ground truth" in the context of expert consensus or pathology typically applies to diagnostic device studies. Performance is measured against established material science standards (ISO 6872:2008).

4. Adjudication method for the test set:

• Not applicable as explained above. Performance is based on physical and chemical testing against a standard.

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 a dental material, not an AI-assisted diagnostic device.

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

• Not applicable. This is a dental material, not an algorithm.

7. The type of ground truth used:

• Material Science Standards: The "ground truth" for the device's performance is established by recognized international standards, specifically ISO 6872:2008 for Dental ceramic. This standard defines the acceptable ranges for various physical and chemical properties.

8. The sample size for the training set:

• Not applicable. This is a physical material being characterized, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable, as there is no training set for this type of device.

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Metal free single posterior crowns, multiple unit anterior crowns/bridges, inlays, onlays bonded dental restorations.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device named "Zirkonzahn Ice," which is classified as "Porcelain Powder for Clinical Use." This document primarily deals with the administrative notification and clearance process rather than detailed study results or acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from this document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance criteria through a new study.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number or qualifications of experts used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results from a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

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