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Ceramill A-Splint is indicated for the fabrication of removable bite splints.

Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).

This document, concerning the Ceramill A-Splint, primarily details a substantial equivalence determination by the FDA for a medical device and does not describe the acceptance criteria and a study proving a device meets them in the context of an AI/algorithmic device. There is no mention of AI, machine learning, or software performance in this document.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI or algorithmic methods from the provided text.

The closest information available that might relate to "acceptance criteria" for this device, which is a physical material for dental applications, are the bench performance testing results compared against the ISO 20795-2:2013 standard.

Here's a breakdown of what can be extracted, interpreting "acceptance criteria" as the performance requirements from the referenced international standard for the physical materials:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information (which are typically relevant for AI/algorithmic device studies):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithmic device, but a physical material. The "test set" here refers to samples of the material itself for physical and chemical property testing. No specific sample sizes for these bench tests are provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing methods, not expert consensus in the way clinical AI ground truth is established.
4. Adjudication method for the test set: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: For the physical material properties, the "ground truth" is derived from established, standardized laboratory measurement techniques (e.g., ISO 20795-2:2013 for dental polymers, ISO 10993-1 for biocompatibility).
8. The sample size for the training set: Not applicable. This is not an AI/algorithmic device, so there is no "training set."
9. How the ground truth for the training set was established: Not applicable.

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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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Zirconium-oxide blanks for permanent and removable dental prosthetics.

Amann Girrbach AG Ceramill® Zolid HT+ white is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape or round-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).

This document is a 510(k) Pre-market Notification for a dental material, Ceramill® Zolid HT+ white, and focuses on demonstrating its substantial equivalence to a predicate device, Ceramill® ZI. It is not an AI/ML device, so many of the requested criteria regarding AI model performance or human reader studies are not applicable.

Here's an analysis of the provided information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (zirconium-oxide blanks for dental prosthetics), acceptance criteria are typically defined by recognized international standards for ceramic dental materials. The study's goal is to show that the new device meets or is equivalent to the predicate device in key performance characteristics relevant to these standards.

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical bench testing of physical and chemical properties of a dental ceramic. It does not involve a "test set" in the context of clinical data or AI model evaluation. Sample sizes would refer to the number of specimens tested for each physical or chemical property (e.g., number of bars for flexural strength, number of samples for density). These specific sample quantities are not provided in the summary, but the testing was conducted according to recognized international standards (ISO, EN), which would specify appropriate sample sizes for such tests.

The data provenance is from bench testing carried out by Amann Girrbach AG (Austrian manufacturer submitting through a Dutch consultant). This is prospective testing of the device properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving interpretation by experts or establishment of ground truth for a diagnostic test. The "ground truth" for the material properties is established by the direct measurement of its physical and chemical characteristics using standardized methods.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study requiring human adjudication for diagnostic outcomes.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

Not applicable. This is a material science study, not a diagnostic imaging study with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable, as this device is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from standardized physical and chemical measurements of the material's properties according to ISO and EN standards. These measurements establish the intrinsic characteristics of the ceramic material.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

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