(86 days)
Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.
Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.
This 510(k) summary provides information for a dental device, "Tender Fiber," and relies on substantial equivalence to predicate devices rather than a direct study demonstrating its performance against specific acceptance criteria. Therefore, much of the requested information regarding specific study details and statistical analysis is not available in this document.
However, I can extract the relevant information and explicitly state what is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5:1999) | "Cytotoxicity tests appears in appendix II.1" (Exact results not provided in this summary, but the report implies compliance.) |
| Physical/Chemical Performance: | |
| ISO 4049:2000 Dentistry - Polymer-Based Filling, Restorative and Luting materials | Device complies with this standard. (Specific performance metrics like flexural strength, depth of cure, etc., are not presented in this summary.) |
| Quality Management Systems: | |
| ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes | Device complies with this standard. |
| Risk Management: | |
| ISO 14971:2000/Amd 1:2003 - MEDICAL DEVICES - Application of risk management to medical devices | Device complies with this standard. |
| Overall Safety and Effectiveness: | "Test results indicate that there are no hazards presented with the use of Tender Fiber as compared with the predicate devices." (No specific acceptance criteria or quantitative performance given, relies on substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Not explicitly stated for performance testing. The document refers to "Cytotoxicity tests" and "Test results," but no details on sample size for these tests are provided.
- Data Provenance: Not specified for any specific test. However, the manufacturer is Micerium SpA, located in Italy, suggesting the tests would have been performed there or commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes a medical device undergoing premarket notification based on substantial equivalence, not a study evaluating human reader performance against ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- No. This is not a study involving AI or human reader comparison. It's a submission for a physical dental device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not explicitly defined in the context of this submission. The "ground truth" here would relate to the performance standards and biocompatibility tests. For biocompatibility, the chemical and biological reactions serve as the "ground truth" against the ISO standards. For physical properties, the measured values compared against the ISO 4049 standard represent the ground truth.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. 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.