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This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

Deflex is a pigmented granulated polyamide resin that belongs to the group of amorphous polyamides or co polyamides, which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). The polyamide granules are pigmented so as to achieve aesthetic effects on the manufactured denture.

The provided text describes a 510(k) summary for a dental device called DEFLEX, a polymer for the injection of denture bases. This document focuses on demonstrating the device's substantial equivalence to a predicate device (TCS unbreakable) rather than proving performance against specific acceptance criteria in a typical clinical study format.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or provided within this type of regulatory submission, as it's not a performance study in the sense of an AI/human reader study.

However, I can extract information related to the closest equivalent of "acceptance criteria" and "reported device performance" based on the non-clinical testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by demonstrating equivalence to the predicate device and meeting relevant established standards. The study "proves" the device meets these criteria by showing it is "at least as safe and effective" as the predicate and compliant with specified test methods.

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

• Sample Size: Not specified in the summary. The non-clinical tests (e.g., mechanical properties, biocompatibility) would have involved defined sample sizes according to the respective standards, but these details are not provided here.
• Data Provenance: The tests were carried out by NUXEN S.R.L. and potentially other laboratories (e.g., for biocompatibility tests adhering to ISO standards). The submitter is based in Buenos Aires, Argentina. The data is inherently "retrospective" as it was gathered to support the 510(k) submission.

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

• Not applicable (N/A). This is a 510(k) summary for a material; it does not involve expert readers establishing ground truth for a diagnostic AI device. The "ground truth" for the non-clinical tests is based on the results of validated laboratory methods and comparison to established standards and the predicate device.

4. Adjudication Method for the Test Set

• N/A. No adjudication method is described as this is not a study involving human interpretation of data where consensus is needed for ground truth.

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

• N/A. No MRMC or human-in-the-loop study was conducted or required for this device. This is a material for manufacturing, not an AI-powered diagnostic tool.

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

• N/A. This device is a material, not an algorithm.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is established by:
  • Validated laboratory test methods: Adherence to defined standards (e.g., EN 20795-1:2009, EN ISO 10993 series).
  • Comparison to predicate device: The performance of the DEFLEX material is compared directly to the TCS unbreakable resin.
  • Material characterization: Internal laboratory methods provide data on the material's properties.

8. The sample size for the training set

• N/A. There is no "training set" in the context of this device. This is not an AI or machine learning device. The material itself is "trained" through its manufacturing process and formulation.

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

• N/A. See point 8.

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This product is indicated for the manufacturing of bases of partial or full removable dentures, r nis products thatoated for the marketing and pneumatic injection of the material, following the Indications of Use that come with the product.

Deflex Acrilato is a pigmented polimethyl-methacrilate (PMMA) resin that belongs to the group of thermoplastic polymers which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). the PMMA granules are pigmented so as to achieve aesthetic effects on the manufactured denture.

The provided text describes a 510(k) summary for a dental device (DEFLEX ACRILATO, a PMMA resin for denture bases). This summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of material properties, rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, expert ground truth, and clinical study designs are not applicable.

Here's the analysis based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission compares the new device to predicate devices, stating that its properties are "similar" or "more resistant" or "much lower." It does not provide specific quantitative acceptance criteria or detailed numerical performance data for these comparisons within the provided text. Instead, it relies on a qualitative comparison to establish substantial equivalence.

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

The document does not specify general "test sets" in the way a diagnostic AI study would. The testing was laboratory-based on material properties.

• Sample Size: Not specified for each test.
• Data Provenance: The device submitter is NUXEN S.R.L. based in Buenos Aires, Argentina. The testing was conducted by an "Internal laboratory" or against recognized standards (EN 20795-1:2009, ANSI+ADA+12-2002+(R2008)). The data is prospective in the sense that the manufacturer conducted these tests specifically for this submission.

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

Not applicable. This is a material science study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a material science study, not a diagnostic study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This is a material science study for a dental resin, not an AI-powered diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device. The device itself is the product being tested (the PMMA resin). The "performance" is its inherent physical and chemical properties.

7. The Type of Ground Truth Used

The "ground truth" here is established by the specified standardized testing methods (EN 20795-1:2009, ANSI+ADA+12-2002+(R2008)) for material properties relevant to dental resins. The data generated from these calibrated tests represents the factual properties of the material.

8. The Sample Size for the Training Set

Not applicable. This is a material science product, not an AI model that requires a training set.

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

Not applicable.

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