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The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.

The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

The provided document is a 510(k) summary for the Inovativ Acetal material, a thermoplastic resin used to fabricate dental prostheses, specifically preformed clasps. This summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or therapeutic medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of submission. The "study" here is essentially the demonstration of substantial equivalence based on material characteristics and intended use.

Here's an attempt to address the request based on the available information:

Acceptance Criteria and Study Details for Inovativ Acetal

Given that this is a 510(k) submission for a material (thermoplastic resin) used in dental prostheses, the "acceptance criteria" are focused on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds for a diagnostic or interventional outcome.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

This information is not applicable as there is no "test set" in the context of a clinical performance study for an AI/diagnostic device. The substantial equivalence is based on a comparison of the material itself and its intended use with a predicate device. The "data provenance" would refer to the characteristics of the material itself and the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. There is no "ground truth" established by experts in the context of evaluating a material's performance against clinical outcomes. The evaluation is primarily based on material science and comparison to an already cleared device.

4. Adjudication method for the test set

This information is not applicable. There was no "test set" requiring adjudication in the context of a clinical performance study.

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

This information is not applicable. The device is a material for dental prostheses, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a material, not an algorithm.

7. The type of ground truth used

This information is not applicable in the sense of expert consensus, pathology, or outcomes data for an AI/diagnostic device. For a material, the "ground truth" for substantial equivalence lies in the established characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable. The device is a material, not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable. The device is a material, not an AI model.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" presented in this 510(k) is a comparative analysis of the Inovativ Acetal material against a legally marketed predicate device: Pressing North America, Inc. material, "Acetal Dental" Acetal resin.

The conclusion of the "study" (as determined by the FDA's letter) is that the Inovativ Acetal device is substantially equivalent to the predicate device. This determination is based on the claim that:

• "The Acetal thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device."
• "Both the Acetal and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."
• A chemical analysis of the Acetal material was provided within the submission to support these claims.

The FDA's August 29, 2002 letter (K022032) confirms this substantial equivalence, allowing the device to be marketed.

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Fabrication of dental prostheses like: clasps on partial prostheses, provisional bridges, space maintainers, partials, active and passive aesthetic containing devices, and gnatological bites.

Acetal Dental / Preformed Clasp

This document is a 510(k) clearance letter from the FDA for a dental device (Acetal/Dental Preformed Clasp). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.

Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It details regulatory information and responsibilities but not the technical data supporting the clearance.

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Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.

Not Found

This looks like a 510(k) clearance letter for a dental device, "Dental D," not a study report with performance metrics.

Therefore, the provided text does not contain the information requested regarding:

• Acceptance criteria and reported device performance.
• Sample size for test set, data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• Ground truth establishment for the training set.

The document is a regulatory letter from the FDA stating that the device is "substantially equivalent" to previously marketed devices for the fabrication of dental prostheses. It outlines the regulatory classification and general controls applicable to the device. There is no mention of a performance study or specific acceptance criteria within this document.

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