The Teno Fix™ Tendon Repair System is delivered sterile. It consists of the implantable stainless steel components, implantation accessories, and installation instruments. The implantable components of the device include the anchors, stop beads, and suture. The stainless steel suture is shipped pre-assembled with a crimped stop bead and tapered needle.

The Teno Fix™ Tendon Repair System is supplied with two preloaded, single-use disposable installation instruments for implantation of the Teno Fix™ anchors. A crimping instrument is supplied to crimp the stop bead to the stainless steel core suture thus controlling the overall length of the implanted device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ortheon Medical Teno Fix™ Repair System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list numerical acceptance criteria in terms of performance metrics (e.g., tensile strength, healing rates). Instead, the acceptance criteria are framed in terms of meeting recognized standards and demonstrating substantial equivalence to predicate devices, as well as being safe and effective.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Standards	ASTM F899-95	Meets the requirements of the stated standard.
	ASTM F138-00	Meets the requirements of the stated standard.
Sterilization	ANSI/AAMI/ISO 11137-1994	Meets the requirements of the stated standard.
Technological Characteristics	Similar to predicate devices (Surgical Stainless Steel Sutures by Ethicon and Peters Pharmaceutical Laboratory, Prolene sutures by Ethicon).	Eleven (11) technological characteristics were compared and found to be similar to predicate devices.
Biocompatibility	Substantial equivalence to predicate devices, demonstrated through comparative testing.	Demonstrated in canine studies, showing biocompatibility of materials.
Implant Stability	Substantial equivalence to predicate devices, demonstrated through comparative testing.	Demonstrated in canine studies, showing stability of the implant within the tendon.
Healing Improvement	Ability to improve healing of the injury over predicate devices by reducing the gap between severed ends of the tendon.	Demonstrated in canine studies.
Overall Performance	Performs as well or better than predicate devices.	Shown through clinical study in humans.
Safety & Effectiveness	Safe and effective for its intended use.	Shown through clinical study in humans.
Design Control	Designed and developed utilizing design control methods in compliance with 21CFR820.	Complies with 21CFR820.
Manufacturing	Manufactured per specifications and good manufacturing practices.	Manufactured per specifications and good manufacturing practices to ensure safety and effectiveness.
Predicate Equivalence	Substantially equivalent to listed predicate devices for regulatory purposes.	FDA determined the device is substantially equivalent to legally marketed predicate devices (K931271, K991073, and reclassified Prolene sutures).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Canine Studies: Not explicitly stated, but "comparative testing in canines" is mentioned.
- Human Clinical Study: Not explicitly stated. The document only mentions "Results of a comparative clinical study in humans."
Data Provenance: The document implies both animal (canine) and human clinical data were used. The country of origin for the studies is not specified. The studies appear to be prospective, as they are referred to as "comparative bench testing," "comparative testing in canines," and "comparative clinical study in humans" to demonstrate equivalence and performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The document refers to "clinical study" results but does not detailing the study design, including the number or qualifications of experts involved in establishing ground truth or evaluating outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document. The document refers to "clinical study" results but does not detailing the study design, including any adjudication methods employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study is not indicated. The document refers to a "comparative clinical study in humans" demonstrating the device performs "as well or better than the predicate devices" and "is safe and effective." However, it does not describe a study where human readers (e.g., surgeons evaluating outcomes from images or reports) improved with AI assistance versus without. The Teno Fix™ is a physical surgical device, not an AI diagnostic tool, so an MRMC study in this context would be irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not done. The Teno Fix™ is a physical medical device (tendon repair system) and does not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant to this submission.

7. The Type of Ground Truth Used

Based on the description of the studies:

Canine Studies: Likely involved direct observation of healing, measurement of tendon gap reduction, and histological assessment of biocompatibility and implant stability. This would be considered outcomes data and potentially pathology.
Human Clinical Study: Likely involved clinical assessment of patient outcomes, such as range of motion, pain levels, strength, complications, and potentially imaging to assess healing. This would be considered outcomes data and clinical assessment.

8. The Sample Size for the Training Set

Not applicable. As the Teno Fix™ is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for a physical medical device.

Summary

{0}------------------------------------------------

510(k), Ortheon Medical Teno Fix™ Repair System

Page 60 of 61

Summary of Safety and Effectiveness for the Ortheon Medical Teno Fix™ Tendon Repair Device

Submitted by

MAY 1 5 2003

Ortheon Medical, LLC 7151 University Blvd. Winter Park, Florida 32792 Phone: (407) 671-2944

Identification of a Legally Marketed Predicate Device

The Teno Fix™ tendon repair system is substantially equivalent to the Surgical Stainless Steel Sutures manufactured and marketed by Ethicon Incorporated, a Johnson & Johnson Company pursuant to K931271, as well as to the Surgical Stainless Steel Sutures manufactured by Peters Pharmaceutical Laboratory and marketed in the USA by CardioThoracic Systems, Inc., under the Acier brand name pursuant to K991073. The Teno Fix™ tendon repair system is also substantially equivalent to Prolene sutures, which are also manufactured and marketed by Ethicon Incorporated, a Johnson & Johnson Company, pursuant to reclassification as Class II devices on May 31, 1991.

General Description

Intended Use

The Ortheon Medical Teno Fix™ tendon repair system is indicated for the repair of severed or lacerated digital flexor tendons.

Summary of Technological Characteristics

Eleven (11) technological characteristics of the Teno Fix™ were compared to the predicate device and were found to be similar.

Summary of Performance Data

The Teno Fix™ meets the requirements of the following recognized consensus standards.

ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical Instruments
ASTM F138 00. Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

{1}------------------------------------------------

510(k). Ortheon Medical Teno Fix™ Repair System

[previously titled ASTM F138-92, Standard Specification for Stain Wire for Surgical Implants (Special Quality)]

Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization, ANSI/AAMI/ISO 11137-1994, Approved 25 May 1994 by Association for the Advancement of Medical Instrumentation, Approved 11 July 1994 by American National Standards Institute, Inc.
Comparative bench testing has established substantial equivalence to the predicate devices. Furthermore, the device has similar technological characteristics to the predicate devices.

Comparative testing in canines shows substantial equivalence to the predicate devices, demonstrating the biocompatibility of the materials, stability of the implant within the tendon, and the ability of the product to improve healing of the injury over the predicate devices by reducing the gap between severed ends of the tendon.

Results of a comparative clinical study in humans shows the Teno Fix™ Tendon Repair System performs as well or better than the predicate devices, and that it is safe and effective.

The Teno Fix™ Tendon Repair System:

meets the requirements of the stated standards;
embodies technological characteristics essentially identical to those of the predicate . devices:
has been shown through clinical study that it performs as well or better than the predicate devices:
has been shown through clinical study it is safe and effective: and .
has been designed and developed utilizing design control methods in compliance . with 21CFR820.

The Teno Fix™ is manufactured per specifications and good manufacturing practices which ensure the device is safe and effective for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2003

Ortheon Medical, LLC c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K023594

Trade/Device Name: Teno Fix™ Tendon Repair System Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: March 5, 2003 Received: March 5, 2003

Dear Mr. Kahan:

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. Iisting 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 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.

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); 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.

{3}------------------------------------------------

Page 2 - Mr. Jonathan S. Kahan

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), please contact the Office of Compliance at (301) 594-4659. 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) you may obtain. 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

Page_1_of_1_

510(k) Number (if known): K023594

Device Name Teno Fix™ Tendon Repair System

Indications for Use:

The Ortheon Medical Teno Fix™ Tendon Repair System is intended for the repair of severed or lacerated digital flexor tendons.

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023594

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96

Regulation Number and Section

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.