(126 days)
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.
| Test/Property | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (manufacturing bases of partial/full removable dentures, occlusal splints, and night guards). | Same intended use as the predicate device. |
| Indications of Use | Similar to predicate. | Similar indications of use as the predicate device. |
| Flexural Strength | Equal to or better than predicate. | "Being DEFLEX more resistant than its predicate." (Implies better flexural strength). |
| Characterization | Consistent with polyamide family and suitable for dental applications. | "Both materials belong to the polyamide family." Confirmed through Material Characterization (Internal laboratory method) and Mechanical properties (EN 20795-1:2009 / ANSI+ADA+12-2002+(R2008)). |
| Swelling | Compliant with EN ISO 10993-13:2009 for biological evaluation of medical devices - Identification and quantification of degradation products. | Tested per EN ISO 10993-13:2009. (Detailed results not provided in summary, but implied to be acceptable for substantial equivalence). |
| Degradation Products | Compliant with EN ISO 10993-13:2009. | Tested per EN ISO 10993-13:2009. (Implied to be acceptable for substantial equivalence). |
| In Vitro Cytotoxicity | No significant cytotoxicity. | Tested via Direct Contact (EN ISO 10993-5:2009), Agar Diffusion (EN ISO 7405:2008), and Filter Diffusion (EN ISO 7405:2008). (Implied to be acceptable). |
| Intracutaneous Reactivity | No significant reactivity. | Tested per EN ISO 10993-10:2010. (Implied to be acceptable). |
| Delayed Hypersensitivity | No significant hypersensitivity. | Tested per EN ISO 10993-10:2010. (Implied to be acceptable). |
| Subacute Systemic Toxicity | No significant systemic toxicity. | Tested per EN ISO 10993-11:2009. (Implied to be acceptable). |
| Genotoxicity (Ames Test) | No genotoxic potential. | Tested per EN ISO 10993-3:2009. (Implied to be acceptable). |
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.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.