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Device for fabrication of dental bases for removable dentures.

The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.

The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.

This document describes the M-PM-Disc (Pink), a dental device used for the fabrication of dental bases for removable dentures. The submission is a 510(k) premarket notification to the FDA. The following information addresses the requested points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M-PM-Disc (Pink) are based on international standards for dentistry (ISO 10477 and ISO 20795-1). The device's performance is reported directly against these standards.

The device also underwent biocompatibility testing according to ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10.2 (guinea pig sensitization model), and "met the applicable standards", showing it was nontoxic and non-sensitizing.

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

The document does not explicitly state the sample sizes for the test sets used for each specific physical parameter measurement. However, typical laboratory testing for material properties involves multiple samples to ensure statistical significance. The data provenance is implied to be from Merz Dental GmbH's internal testing, as they "tested OMP-N for physical/chemical properties and biocompatibility." The country of origin of the data would be Germany, given Merz Dental GmbH's address. The data is prospective, generated specifically for this regulatory submission.

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

This document does not involve a test set requiring expert ground truth in the way a medical imaging AI would. The "ground truth" for the material properties is established by the standardized testing methodologies of ISO 10477 and ISO 20795-1. The experts involved would be the laboratory technicians and scientists performing the tests and interpreting the results according to these international standards. Their qualifications would involve expertise in materials science, mechanical testing, and adherence to ISO guidelines.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of material properties by objective, standardized laboratory tests does not typically involve human adjudication in the same way clinical diagnostic assessments do. Results are typically measured directly and compared against pre-defined thresholds within the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a material for dental fabrication, not a diagnostic AI tool that would involve human readers interpreting cases.

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

Yes, in a sense, a "standalone" evaluation of the material properties was performed. The OMP-N PMMA material was tested in isolation, and its physical and biocompatibility characteristics were measured and compared directly against performance standards. There is no "human-in-the-loop" performance associated with the material's inherent properties.

7. The Type of Ground Truth Used

The ground truth used for evaluating the M-PM-Disc (Pink) is based on established international standards for dentistry (ISO 10477, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). These standards define the acceptable range or minimum/maximum values for various physical, chemical, and biological properties of dental polymer materials.

8. The Sample Size for the Training Set

Not applicable. This submission is for a material (M-PM-Disc), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The robust properties of the PMMA material are inherent to its composition and manufacturing process.

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

Not applicable, as there is no training set for an AI algorithm. The material's properties (strength, water sorption, etc.) are intrinsic and established through standardized scientific testing processes.

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