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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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The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.

The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.

The provided document describes a 510(k) premarket notification for a dental device, the Merz Dental GmbH M-PM-Disc (Clear). This submission focuses on establishing substantial equivalence to previously marketed devices based on non-clinical testing and shared material properties, rather than an AI/ML-based device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable in this context.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is not an AI/ML study. The "test set" here refers to physical and chemical tests on the material itself, not a dataset for an algorithm. The testing was performed on the PMMA material used in the device and a virtually identical PMMA from a previously approved device (Merz Dental artegral plastic teeth).

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

Not applicable. This is not an AI/ML study. Ground truth was established by adherence to recognized international standards (ISO 1567, ISO 10993-1, ISO 3336:1996) and laboratory testing. The qualifications of the testing personnel are not disclosed but would presumably be laboratory technicians and engineers experienced in material science testing.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML study. Compliance with ISO standards is determined by predefined testing protocols, not human adjudication in the typical sense of a clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML study, and therefore, an MRMC comparative effectiveness study was not conducted. The study focuses on material properties and biocompatibility.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI/ML device or algorithm. The performance being evaluated is the physical and biological characteristics of the dental material.

7. Type of Ground Truth Used

The ground truth used was international standards for material properties and biocompatibility. Specifically:

• Physical Properties: ISO 1567 (Dentistry - Denture Base Polymers)
• Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)
• Material Composition: ISO 3336:1996 (Dentistry - Synthetic Polymer Teeth)

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML study and does not involve a training set. The "training" here would refer to the extensive research and development process that led to the formulation of the PMMA material, not a data training set for an algorithm.

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

Not applicable. There is no training set in the context of an AI/ML device. The "ground truth" for the material's development would be based on established principles of polymer chemistry and dental material science, aiming to meet the performance criteria outlined in the relevant ISO standards.

Summary of the Study and Device Justification:

The study aims to demonstrate that the Merz Dental GmbH M-PM-Disc (Clear) device is substantially equivalent to predicate devices. This is achieved through non-clinical testing, primarily focusing on:

• Identical Intended Use: Fabrication of removable bite splints (mouthguards and nightguards).
• Identical Composition: Acrylic Polymer (PMMA).
• Identical Colorants: None (Clear).
• Compliance with Relevant ISO Standards for Physical Properties: The device's PMMA material was tested according to ISO 1567 for Flexural Strength, Flexural Modulus, Water Absorption, and Solubility. The reported performance meets the limits specified by the standard.
• Compliance with Relevant ISO Standards for Biocompatibility: The PMMA material was tested according to ISO 10993-1, demonstrating it was non-cytotoxic, non-irritating, and non-sensitizing. This testing was performed on a virtually identical PMMA (Merz Dental artegral plastic teeth) which confirmed the material's biocompatibility.
• Compliance with Material Standard: The PMMA material (as represented by the artegral plastic teeth) also meets the requirements of ISO 3336:1996.

The key difference noted is the fabrication method (milling for the M-PM-Disc (Clear) vs. thermoforming for the predicate K062828). However, the material properties and biocompatibility, as confirmed by non-clinical testing against established ISO standards, justify its substantial equivalence. No clinical testing was deemed necessary.

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