(123 days)
TCS Blend is a break resistant material used for the fabrication and repair of base plates for removable dental prosthetic appliances. This includes, but not to be limited to, partial or full removable dentures, orthodontic devices, occlusal splints and night guards.
TCS Blend is an injection moldable, flexible, break-resistant 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.
TCS Blend is used for fabricating removable dental prosthetic appliances such as full and partial dentures, orthodontic devices, occlusal splints and night guards.
The provided text describes the TCS Blend device, a dental resin, and its substantial equivalence to a predicate device, TCS Unbreakable. The focus of the document is on demonstrating the safety and effectiveness of TCS Blend through biocompatibility and performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct "acceptance criteria" table with specific quantitative thresholds. Instead, it states that the device was tested against recognized standards, and the results "demonstrate that the TCS Blend meets the performance criteria specified in the recognized standards cited for the performance of the predicate device." This implies that the acceptance criteria are adherence to these standards.
| Acceptance Criteria (Implied from Standards) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Non-cytotoxic | Confirmed Non-cytotoxic |
| - Non-sensitizing | Confirmed Non-sensitizing |
| - Non-irritating | Confirmed Non-irritating |
| - Non-mutagenic | Confirmed Non-mutagenic |
| Performance (per ANSI/ADA Spec No. 12:2002/ISO 1567:1999 for Denture Base Polymers): | Meets performance criteria (specific quantitative results not provided) |
| Performance (per ANSI/ADA Spec No. 80:2001/ISO 7491:2000 for Dental Materials - Determination of Color Stability): | Meets performance criteria (specific quantitative results not provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated for performance or biocompatibility testing. The document mentions "test results" and "study results" but not the number of samples or specimens used in these tests.
- Data Provenance: Not explicitly stated. However, given that Thermoplastic Comfort Systems, Inc. is a U.S. company, and the submission is to the FDA, it is highly likely the testing was conducted under U.S. regulatory guidelines or by laboratories that adhere to international standards (ISO). The testing appears to be prospective as it was conducted specifically for the TCS Blend device to demonstrate its performance and safety for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The testing described (biocompatibility and performance to standards) does not involve human expert interpretation for establishing ground truth as one might find in an AI medical imaging study. Instead, the "truth" is determined by established laboratory testing protocols and objective measurements against defined material specifications.
4. Adjudication method for the test set:
Not applicable. As stated above, this study involves objective material characterization, not human interpretation that would require adjudication.
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:
Not applicable. This device is a material (dental resin), not an AI diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science study, not an algorithm performance study.
7. The type of ground truth used:
The ground truth used for this device's evaluation is primarily objective measurements against recognized consensus standards (e.g., ISO, ANSI/ADA specifications) for material properties and biocompatibility. For biocompatibility, this includes biological responses (cytotoxicity, sensitization, irritation, genotoxicity) measured in laboratory assays. For performance, this refers to physical and chemical properties (e.g., strength, color stability) measured according to specified test methods.
8. The sample size for the training set:
Not applicable. This study is not a machine learning or AI study, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant.
§ 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.