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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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