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Thermoforming Sheet Materials Track A, B, E and Bleach are indication of orthodontic and dental appliances.

Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products: Thermoforming Sheet Materials: Track A, Track B, Track E, Track bleach.

The provided text is a 510(k) summary for Thermoforming Sheet Materials. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for device performance in the context of an AI/algorithm-based medical device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not available in the provided document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for device performance that would typically be associated with an AI/algorithm. Instead, it demonstrates compliance with international standards for biocompatibility and provides a list of physical properties that were tested according to other ISO standards.

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

Not applicable. This device is a material, not an AI/algorithm that uses a test set of data. The testing mentioned in the document relates to material characterization.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth is a concept related to labeling data for AI/algorithm development and evaluation. This document describes physical material testing.

4. Adjudication Method:

Not applicable. This is relevant for establishing ground truth in AI/algorithm studies.

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

Not applicable. This type of study assesses human performance with and without AI assistance, which is not relevant for a material-based device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is not an algorithm.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" here would be the physical properties and biocompatibility of the material itself, determined through standard laboratory tests, not expert consensus or pathology on a dataset.

8. Sample Size for the Training Set:

Not applicable. This device is a material, not an AI/algorithm that requires a training set.

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

Not applicable.

Summary from the provided document:

The provided document details a 510(k) premarket notification for Thermoforming Sheet Materials. The focus is on demonstrating substantial equivalence to an existing predicate device (K200125 from Erkodent Erich Kopp GmbH). The core of the justification is that the proposed device, the Thermoforming Sheet Materials, are similar in:

• Indications for Use: Fabrication of orthodontic and dental appliances.
• Material: Resin / Thermoplastic.
• Fabrication Method: Thermo-Molding Custom-Fit.
• Prescription Device: Yes.
• Re-Usable Device: Yes, single consumer/patient.
• Sterility: Non-Sterile.
• Biocompatibility: Yes.

Non-Clinical Testing: The document states that non-clinical testing was performed for biocompatibility according to EN ISO 10993-1 and FDA Guidance, and physical properties according to various ISO standards. The results demonstrated compliance for biocompatibility. Specific numerical values for the physical properties were not provided in this summary.

Clinical Testing: No clinical testing was performed in support of this submission.

In conclusion, the document does not contain the type of acceptance criteria and study information typically found for AI/algorithm-based medical devices. It is a regulatory submission for a physical material, demonstrating equivalence to a lawfully marketed predicate.

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