Ribbond-Triaxial is intended to provide reinforcement to acrylic or composite resins used for dental restorations. It is used by dentists and dental technicians. It can be used for the following applications:

As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances.

To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.

To reinforce splints used to immobilize teeth.

Device Description

Ribbond-Triaxial is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecular-weight polyethylene (UHMW). The fibers are braided using a triaxial braid and subjected to a plasma treatment to improve its ability to bond to resins.

AI/ML Overview

This document is a 510(k) summary for Ribbond-Triaxial, a dental fiber reinforcement material. The core of the submission revolves around demonstrating substantial equivalence to a predicate device, Ribbond (cleared under K913040), rather than outlining explicit acceptance criteria and an independent study for novel performance.

Therefore, the requested information relies heavily on interpretation of the provided text, as a traditional "acceptance criteria vs. reported device performance" table is not explicitly present in the format typically seen for novel device submissions. The submission focuses on design characteristics and their impact on load-carrying capacity, using the predicate device as a benchmark.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety equivalent to predicate device	No new hazards presented as with the predicate device.
Effectiveness equivalent to predicate device	The different design characteristics... demonstrates that the device is as safe and effective as the predicate device.
Specific Performance Metric: Greater load carrying capacity compared to Ribbond (predicate device, leno-weave)	Ribbond-Triaxial has greater load carrying capacity than the leno-weave.
Ability to bond to resins similar to or improved over predicate	Subjected to a plasma treatment to improve its ability to bond to resins.

Study Details

It's important to note that the document describes "tests" rather than a formal, detailed "study" with explicit methodologies, sample sizes, and statistical analysis as would be expected for a de novo device. The information provided is very limited.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Tests show that Ribbond-Triaxial has greater load carrying capacity." This implies tests were conducted, but the number of samples tested is not mentioned.
- Data Provenance: Not specified. It can be inferred that the tests were conducted by the manufacturer, Ribbond, Inc., but the location or whether it was retrospective/prospective is not stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "tests" mentioned are for mechanical properties (load carrying capacity), not diagnostic accuracy requiring expert interpretation of ground truth.
Adjudication method for the test set:
- Not applicable, as the tests relate to mechanical properties, not expert-based assessment.
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 an AI-enabled device, nor is it a diagnostic device that would typically undergo an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical material, not an algorithm.
The type of ground truth used:
- For the "load carrying capacity" test, the ground truth would be the objectively measured mechanical force required to cause failure or deformation, as per standard engineering and material testing protocols. This is a direct measurement, not an interpreted "ground truth" derived from experts or pathology in a medical context.
The sample size for the training set:
- Not applicable. This is a physical material with mechanical properties undergoing direct testing, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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Section E: 510(K) Summary

Applicant:

K01388/

Ribbond, Inc. 1420 30 AVE STE 1030 Seattle, WA 98101 Tel: 206-340-8870 Fax: 206-382-9354 E-mail: shosh@ribbond.com

JAN 2 5 2002

Contact person:	Shoshana Rudo Driver
Date prepared:	October 22, 2001
Device Trade Name:	Ribbond-Triaxial
Device Common Name:	Fiber reinforcement material
Device Classification Name:	Denture realigning, repairing or rebasingresin (CFR 872.3760)

Description of Device:

Doseription of Do 1001
Ribbond-Triaxial is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecular-weight polyethylene (UHMW). The fibers are braided using a triaxial braid and subjected to a plasma treatment to improve its ability to bond to resins.

Intended Use:

Ribbond-Triaxial is intended to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications:

As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances.

To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.

To reinforce splints used to immobilize teeth.

Substantial Equivalency:

Ribbond-Triaxial is substantially equivalent to Ribbond, cleared under K913040 dated October 7, 1991.

Description of new design characteristics

Ribbond-Triaxial is made using a triaxial braid. Ribbond is made using a leno-weave. Tests show that Ribbond-Triaxial has greater load carrying capacity than the leno-weave. The different design characteristics of Ribbond-Triaxial does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device.

Ribbond-Triaxial is made of the UHMW fiber and treated with plasma the same manner as the predicate device. There are no new hazards presented with Ribbond-Triaxial as with the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, positioned to the right. To the left of the figure is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Ms. Shoshanna Rudo Driver Vice President Ribbond, Incorporated 1402 3rd Avenue, Suite 1030 Seattle, Washington 98101

Re: K013881

Trade/Device Name: Ribbond-Triaxial® Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 19, 2001 Received: November 23, 2001

Dear Ms. Driver:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 rir 1), it in 11 mm of one of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 - Ms. Driver

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section D Statement of indications for use

Intended Use:

As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances.

To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.

To reinforce splints used to immobilize teeth.

Susan Runne

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devicesses
510(k) Number ________________________________________________________________________________________________________________________________

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.