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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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DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.

DD medical polymers, made from medical grade, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints (clear variant) on dental CAD/CAM systems.

The document concerns the 510(k) premarket notification for "DD medical polymers" (DD tempMED and DD Bio Splint P) by Dental Direkt GmbH. The device is a resin for temporary crowns, bridges, and bite splints.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from international standards DIN EN ISO 20795-1 and ISO 10477, which pertain to denture base polymers and polymer-based crown and bridge materials, respectively.

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

The document does not explicitly state the sample sizes (number of specimens) used for each mechanical or chemical test. It only mentions that "Finished DD medical polymer products in all variants were tested."

The data provenance is from non-clinical testing performed according to international standards (DIN EN ISO 20795-1 and ISO 10477) and biocompatibility standards (EN ISO 10993-1, -5). These tests were conducted by an accredited, GLP-certified testing laboratory. The country of origin of the data is not explicitly stated beyond the fact that Dental Direkt GmbH is based in Germany and the testing laboratory is accredited. The tests are non-clinical (laboratory-based) and are retrospective in the sense that they are conducted on finished products.

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 provided document pertains to a medical device's physical and chemical properties and biocompatibility, not an AI/CADe/CADx system that would require expert-driven ground truth for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. The "ground truth" here is defined by the requirements of the international standards themselves, measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance

This information is not applicable as the device is a dental material, not an AI-assisted diagnostic or treatment planning system.

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

This information is not applicable as 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 by the specified limits set forth in the following international standards:

• DIN EN ISO 20795-1:2013: Dentistry - Base polymers - Part 1: Denture base polymers
• ISO 10477:2004: Dentistry Polymer-based Crown and Bridge Materials
• EN ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (for biocompatibility)
• EN ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (for biocompatibility)

These standards define objective physical, chemical, and biological performance criteria.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical material, not an AI model that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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