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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.

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.

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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

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.

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TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

Not Found

The provided text is a 510(k) substantial equivalence letter from the FDA for a dental material (TCS® Unbreakable) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

Ask a specific question about this device