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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2015

Thermoplastic Comfort Systems, Inc. Ms. Marilin Posca President 2619 Lime Avenue Signal Hill, CA 90755

Re: K142894

Trade/Device Name: TCS Blend Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 4, 2014 Received: November 5, 2014

Dear Ms. Posca:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for TCS, which is a company that provides IT services, consulting, and business solutions. The logo is a lowercase "tcs" in a simple, sans-serif font. The letters are black, and there is a small circle above the "s". To the right of the letters is a partial, curved shape, which is likely part of a larger design element associated with the TCS brand.

510(k) Number (if known): K142894

Device Name: TCS Blend

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thermoplastic Comfort Systems 510(k) for TCS Blend

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Section 5.0: 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Date:

October 2, 2014

Manufacturer Address

Telephone Fax Number Contact at TCS Thermoplastic Comfort Systems, Inc. 2619 Lime Avenue Signal Hill, CA 90755 562-426-2970 562-426-5154 Marilin Posca President marilin@tcsdentalinc.com

E-mail

Device Name and Classification

Trade name/Product Name Common/Usual Name Classification Name

Classification Panel Product Code Regulation Number Class

TCS Blend Dental resin Resin, Denture, Relining, Repairing, Rebasing

Dental EBI 21 CFR 872.3760 -

Predicate Device

Manufacturer Device Name 510(k) Number Thermoplastic Comfort Systems, Inc. TCS Unbreakable K053060

Device Description

TCS Blend is used for fabricating removable dental prosthetic appliances such as full and partial dentures, orthodontic devices, occlusal splints and night guards.

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Image /page/4/Picture/0 description: The image contains the logo for TCS, which is a company. The logo is in lowercase letters and is in a sans-serif font. The letters are in a dark gray color. There is a small star-like symbol above the "s" in the logo.

Indications for Use

Substantial Equivalence

The TCS Blend device is substantially equivalent to the TCS Unbreakable dental resin (K053060).

The claim of substantial equivalence for the TCS Blend is based on intended use, technology and performance specifications. Both the TCS Blend and the predicate device are composed of a thermoplastic, nylon material. Both devices are supplied in a natural or clear state as well as in shades of pink. Both materials are supplied in cartridges which are heated to allow for the injection molding of the fabrication of dental prostheses.

Biocompatibility

Biocompatibility testing of the TCS Blend material was conducted in accordance with ISO standards to demonstrate the safety of the device.

The following biocompatibility tests were conducted:

1. Cytotoxicity: Agar overlay per ISO 10993-5:2009
1. Cytotoxicity: MEM elution per ISO 10993-5:2009
1. Sensitization: Guinea Pig Maximization Sensitization Test per ISO 10993-10:2010
1. Irritation: Intracutaneous Toxicity (ISO) per ISO 10993-10:2010
1. Genotoxicity: Ames Test per ISO 10993-3:2009

The test results confirm that the TCS Blend device is non-cytotoxic, non-sensitizing, nonirritating and non-mutagenic.

Performance Testing to Recognized Standards

The TCS Blend device was tested to the applicable clauses of the recognized consensus standards for dental materials listed below.

1. ANSI/ADA Specification No. 12:2002/ISO 1567:1999 Denture Base Polymers
1. ANSI/ADA Specification No. 80:2001/ISO 7491:2000 Dental Materials -
Determination of Color Stability

The study results demonstrate that the TCS Blend meets the performance criteria specified in the recognized standards cited for the performance of the predicate device, TCS Unhreakable, confirming the substantial equivalence of the TCS Blend to the predicate device.

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Summary of Performance Testing – Conclusion

The results of all testing demonstrate that the TCS Blend device does not raise any new The results of an testing domenstiate that the device when compared to the existing predicate device.

Regulation Number and Section

§ 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.