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510(k) Data Aggregation
(85 days)
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet
Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
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.
| Acceptance Criteria (Not explicitly stated as such for performance, but as compliance to standards) | Reported Device Performance (Summary of compliance) |
|---|---|
| Biocompatibility (according to EN ISO 10993-1 and FDA Guidance) | The insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and the FDA Biocompatibility Guidance Document for the intended dental use. |
| Physical Properties (according to various ISO standards as listed) | "Physical properties have been tested according to the applicable standards." (No specific values reported in this summary). |
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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(281 days)
Thermoforming Sheet Materials
Thermoforming sheet materials are indicated for the fabrication 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 patients individual plaster models. After cooling the sheets are removed from the model and trimmed to fit.
The provided FDA 510(k) clearance document for "Thermoforming Sheet Materials" (K200125) describes non-clinical testing for biocompatibility and physical properties, but it does not contain information about a study involving acceptance criteria related to a device's performance that would require a test set, ground truth established by experts, or MRMC studies.
This submission is for a material (thermoforming sheets) used to fabricate orthodontic and dental appliances, not a diagnostic or AI-driven device. Therefore, many of the requested categories are not applicable.
Here's the information that can be extracted and a clear indication of what is not present in the document based on the device type:
1. A table of acceptance criteria and the reported device performance
The document provides a list of standards the materials were tested against, implying that meeting these standards constitutes the acceptance criteria. The reported performance is that the materials are in compliance with these standards for biocompatibility and that physical properties were tested.
| Acceptance Criteria (Implied by Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 (Biocompatibility) | Insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use. Biological effects considered for leachables (cytotoxicity, mucosa irritation, sensitization, acute systemic and subchronic toxicity, genotoxicity) were evaluated. |
| Compliance with Physical Property Standards (e.g., ISO 62/1 for water absorption, ISO 1183 for density, ISO 527 for tensile strength, etc.) | Physical properties have been tested according to the applicable standards (listed in the document). The document concludes that the proposed device has "the same performance specifications" as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the non-clinical tests.
- Data Provenance: Not specified. The company is based in Germany, so tests may have been conducted there or by a contract lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a material, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with established material science and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This is a material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Adherence to established international and FDA-specific guidance documents and standards (EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350) which involve specific chemical and biological assays.
- For physical properties: Adherence to material testing standards (e.g., various ISO standards) which involve quantifiable measurements.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not Applicable.
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