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DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years.

DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite requlators for long-term application in the oral cavity up to 12 months.

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems.

The provided text is a 510(k) Summary for a medical device (DD medical polymers (PMMA)). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in the format of a clinical or analytical study.

Therefore, the requested information cannot be fully extracted because the document is a regulatory submission for substantial equivalence based on in vitro testing and comparison to existing standards, not a standalone clinical or performance study with detailed acceptance criteria and expert reviews in the typical sense of a diagnostic device.

However, I can extract the relevant information regarding the tests performed to demonstrate substantial equivalence and what serves as the "acceptance criteria" in this context (meeting relevant standards).

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria and device performance in a direct "acceptance criteria vs. reported performance" table format. Instead, it indicates that the device's physical properties "meet the requirements of the relevant standards ISO 20795-1 and ISO 20795-2 as well as the values of the Predicate Device / Reference Device." The table on pages 8-9 provides a comparison of physical characteristics between the new device, primary predicate device, and reference device. The "acceptance criteria" here are implicitly defined by the requirements of the standards and the performance of the predicate/reference devices.

Interpretation based on the provided table (pages 8-9) and text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes used for each physical test. It only states that "Non-clinical testing was performed in order to validate the product against the company's specified design requirements."
• Data Provenance: The company, Dental Direkt GmbH, is located in Spenge, Germany. The testing was performed by "an accredited testing laboratory." The specifics of whether the data were retrospective or prospective are not mentioned, but in vitro physical and biocompatibility testing is typically prospective for new device submissions.

3. 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)

This is not applicable. The tests performed are non-clinical (physical and biocompatibility) against established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5). Ground truth is established by these standards' methodologies and acceptance criteria, not by expert consensus in clinical interpretation.

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

This is not applicable, as the document refers to non-clinical physical and biocompatibility testing not requiring adjudication involving expert readers.

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 is a dental material (PMMA milling blanks) and not an AI-powered diagnostic device or an imaging product requiring human reader interpretation. No MRMC study was performed.

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

This is not applicable, as the device is a dental material and not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is based on:

• Established international standards (ISO 20795-1, ISO 20795-2, EN ISO 10993-1, EN ISO 10993-5).
• The performance values of legally marketed predicate and reference devices.
• The company's specified design requirements validated by testing.

8. The sample size for the training set

This is not applicable, as this is a physical medical device (materials) and does not involve AI or algorithms that require a training set.

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

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

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For manufacturing by a CAD/CAM System:

• Provisional anterior and posterior crowns with a maximum wear period of up to 12 months

• Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months

• Provisional inlay and onlays

Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TelioCAD Multi device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily references meeting existing ISO standards rather than defining new, specific acceptance criteria with numerical targets. The "Reported Device Performance" simply states that the device "met all requirements of the standard."

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

The document does not specify the sample sizes used for the tests conducted according to the ISO standards.
The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer as part of their 510(k) submission.

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

This type of information is not applicable to this document. The "ground truth" here is defined by objective physical and chemical measurements against established international standards for dental materials, not through expert consensus or clinical judgment on a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective material testing against ISO standards, not on human interpretation that would require an adjudication method.

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 information is not applicable. TelioCAD Multi is a dental material (PMMA discs for temporary restorations), not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study and effect size in this context are irrelevant.

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

This information is not applicable. As stated above, this device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established international standards for dental materials (ISO standards 10477:2004, 20795-1:2013, 179-1:2010, 180:2000, 868:2003, 10993-1, 7504). These standards define the acceptable physical, mechanical, and biological properties for the material's intended use.

8. The Sample Size for the Training Set

This information is not applicable. This device is a material, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

Ask a specific question about this device