(85 days)
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.
| Test | Standard or Test Method Applied | Reported Device Performance (Relative to Predicate) |
|---|---|---|
| Material Characterization | Internal laboratory method | Comparable to predicate (VERACRYL) |
| Mechanical Properties | EN 20795-1:2009 (ANSI+ADA+12-2002+(R2008)) | More resistant than predicate (TCS unbreakable) |
| Residual MMA Monomer Content | EN 20795-1:2009 (ANSI+ADA+12-2002+(R2008)) | Similar to predicate (VERACRYL) |
| Water Absorption | EN 20795-1:2009 (ANSI+ADA+12-2002+(R2008)) | Similar to predicate (VERACRYL) |
| Water Solubility | EN 20795-1:2009 (ANSI+ADA+12-2002+(R2008)) | Much lower than predicate (VERACRYL) |
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.
§ 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.