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Fabrication of dentures.

PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

The provided document describes the 510(k) premarket notification for the "PINK CAD/CAM Disc" for fabrication of dentures and compares it to a predicate device ("M-PM-Disc (Pink)") and a reference device ("PMMA CAD/CAM disc").

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size for each test. For the E-modulus, flexural strength, and residual methyl methacrylate, it refers to "The test results... have been obtained with PINK CAD/CAM disc" and "The performance characteristics have been determinat_ed_ with PINK CAD/CAM disc," implying a test set was used, but the number of samples is not specified. For biocompatibility tests, it mentions that "testing was conducted on reference device PMMA CAD/CAM disc composed of Polident PMMA CAD/CAM disc material," again without specifying the sample size.
• Data Provenance: The data appears to be prospective as the tests were "conducted" for the purpose of this 510(k) submission. The country of origin for the data generation is not explicitly stated, but the manufacturer (Polident d.o.o.) is based in Slovenia, suggesting the studies were conducted or commissioned there.

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

• This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics of dental materials like E-modulus, flexural strength, and residual monomer content is established by standardized laboratory testing methods (e.g., EN ISO 20795-1) and objective measurements, not by expert consensus or interpretation of subjective data. Similarly, biocompatibility studies (EN ISO 10993 series) involve standardized biological assays and observation, not expert ground-truthing in the sense of clinical image analysis.

4. Adjudication Method for the Test Set:

• This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical or diagnostic studies where subjective interpretation is involved and consensus among experts is required to establish a ground truth. The tests performed for this device are quantitative and objective.

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:

• This is not applicable. The device "PINK CAD/CAM disc" is a material for fabricating dentures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

• This is not applicable. The device is a physical material, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established through standardized laboratory testing using recognized international standards (EN ISO 20795-1 for mechanical and chemical properties, EN ISO 10993 series for biocompatibility). These standards define the test methodologies and acceptable limits, providing an objective "ground truth" for material properties and biological safety.

8. The Sample Size for the Training Set:

• This is not applicable. The device is a physical material, not a machine learning model or algorithm, so there is no concept of a "training set" for its development or evaluation in this context. The manufacturing process is controlled, and the performance is verified through testing of representative samples.

9. How the Ground Truth for the Training Set Was Established:

• This is not applicable as there is no training set.

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• fabrication of temporary crowns and bridges.

PMMA CAD/CAM discs are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

Here's an analysis of the provided text regarding the PMMA CAD/CAM disc, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification summary. This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials. Therefore, the "acceptance criteria" discussed here are primarily related to material properties and safety tests, demonstrating equivalence to the predicate, rather than clinical performance metrics typically found in efficacy studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific "test set" in the context of a clinical performance study. The equivalence is primarily based on material characterization and bench testing.

• Sample Size: Not applicable in the context of a clinical test set. The material testing would have involved specific sample sizes for each physical/chemical property test, but these details are not provided in this summary.
• Data Provenance: Not applicable for a clinical test set. The data would be derived from laboratory tests conducted on the PMMA CAD/CAM disc itself. No country of origin for clinical or retrospective/prospective data is mentioned as such studies were not performed for this submission.

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

This information is not applicable as the submission is for substantial equivalence based on material properties and bench testing, not on clinical performance requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a dental material (PMMA disc), not an AI-assisted diagnostic or therapeutic device. Therefore, no "human readers" or "AI assistance" are involved in its primary function for evaluating its effectiveness in the context of this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence relied on:

• Material Science Benchmarks: Comparing the physical and chemical properties of the PMMA CAD/CAM disc to those of the predicate device.
• Biocompatibility Standards: Results from cytotoxicity, sensitization, and irritation testing, presumably against recognized standards or established safety profiles.
• Predicate Device Characteristics: The established and legally marketed characteristics of the ZENO PMMA disc served as the primary "ground truth" for comparison.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (dental material), not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device type.

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