(66 days)
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
i.flex by TCS is an injection moldable, flexible, thermoplastic resin provided with trace amounts of colorant added to produce shades of pink. The dental resin is packaged in individual use cartridges or in bulk. i.flex by TCS is used for fabricating removable dental prosthetic appliances such as full and partial dentures, occlusal splints and night guards.
The provided text describes a 510(k) summary for the i.flex by TCS dental resin, which is a thermoplastic resin used for fabricating removable dental prosthetic appliances. The document focuses on demonstrating the substantial equivalence of the i.flex by TCS device to a predicate device (DuraFlex K063626) by comparing their intended use, technology, and performance specifications.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (Agar overlay) | Non-cytotoxic | Confirmed non-cytotoxic |
| Cytotoxicity (MEM elution) | Non-cytotoxic | Confirmed non-cytotoxic | |
| Delayed-type hypersensitivity (sensitization) | Non-sensitizing | Confirmed non-sensitizing | |
| Irritation (Intracutaneous Toxicity) | Non-irritating | Confirmed non-irritating | |
| Genotoxicity (Ames Test) | Non-mutagenic | Confirmed non-mutagenic | |
| Performance to Recognized Standards | ANSI/ADA Spec. No. 12:2002/ISO 1567:1999 (Denture Base Polymers) | Meets criteria specified in standard or for predicate device | Meets performance criteria |
| ANSI/ADA Spec. No. 80:2001/ISO 7491:2000 (Dental Materials - Determination of Color Stability) | Meets criteria specified in standard or for predicate device | Meets performance criteria |
2. Sample Sizes and Data Provenance
The document does not specify sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective) for the biocompatibility or performance testing. It generally states that "testing of the i.flex by TCS material was conducted" and "The i.flex by TCS device was tested."
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The studies conducted are laboratory-based tests comparing material properties to recognized standards, rather than clinical studies requiring expert interpretation of results for ground truth.
4. Adjudication Method
This information is not applicable for the type of testing described (biocompatibility and performance to standards). No human interpretation or adjudication of an "image" or "case" is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating the diagnostic performance of AI algorithms in conjunction with human readers, which is not relevant to the material property testing presented here.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study in the context of an algorithm's performance was not conducted. The performance testing refers to the physical and chemical properties of the dental resin itself, not a computational algorithm.
7. Type of Ground Truth Used
The ground truth used for performance testing was based on:
- Recognized consensus standards: Specifically, ANSI/ADA Specification No. 12:2002/ISO 1567:1999 for Denture Base Polymers and ANSI/ADA Specification No. 80:2001/ISO 7491:2000 for Dental Materials - Determination of Color Stability.
- Predicate device performance: The i.flex by TCS was shown to meet the performance criteria established by these standards or to be comparable to the predicate device, DuraFlex (K063626).
- ISO standards for biocompatibility: ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2010 for Hypersensitivity and Irritation, and ISO 10993-3:2009 for Genotoxicity.
8. Sample Size for the Training Set
This information is not applicable as the document describes material property testing, not an AI algorithm requiring a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.