OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.

Device Description

OrthoMend is a remodelable collagen matrix used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the OrthoMend™ device, a remodelable collagen matrix used to reinforce soft tissues. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in a clinical setting.

Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies are not applicable to this type of regulatory submission. The document primarily highlights biocompatibility testing and shared technological characteristics with existing devices to claim substantial equivalence.

Here's an breakdown of the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The submission is for substantial equivalence to legally marketed predicate devices, not for demonstrating performance against specific clinical acceptance criteria. The document lists biocompatibility tests as an assessment performed, but doesn't define "acceptance criteria" or report specific "device performance" in a quantitative clinical sense.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This 510(k) submission does not describe a clinical study with a test set of data for performance evaluation. It mentions biocompatibility testing and viral inactivation testing, which are typically conducted on material samples in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no discussion of a test set with ground truth established by experts in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. There is no test set or adjudication method described.

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 document pertains to a medical device (collagen matrix), not an AI-assisted diagnostic or treatment system, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No ground truth for an algorithm or diagnostic performance is discussed. The "ground truth" in this context would be the successful demonstration of biocompatibility and manufacturing safety, which were assessed by an independent certified laboratory.

8. The sample size for the training set

Not Applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not Applicable. There is no training set.

Summary of Relevant Information from the Document:

Device Description: OrthoMend™ is a remodelable collagen matrix used to reinforce soft tissues where weakness exists. It is supplied sterile in sheet form to be trimmed and sutured by the surgeon.

Intended Use: For surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. Additionally, it is intended to reinforce soft tissues (limited to the supraspinatus) repaired by suture or suture anchors during rotator cuff surgery.

Predicated Devices:

TissueMend Soft Tissue Repair Matrix (TEI Biosciences, K020455)
Restore Orthobiologic Soft Tissue Implant (DePuy, K001738)

Biocompatibility Assessment:

A "rigorous biocompatibility assessment" was performed by an independent certified laboratory.
Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
Manufacturing Safety: The manufacturing methods for OrthoMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.

Basis for Equivalence: OrthoMend™ is claimed to be substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet that can be sutured, and its full resorbability over months.

Conclusion: The 510(k) notification for OrthoMend™ relies on demonstrating substantial equivalence to existing legally marketed devices, supported by biocompatibility and viral inactivation testing, rather than an independent clinical study with predefined acceptance criteria and performance metrics.

Summary

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

TEI BIOSCIENCES INC. JUN 2 7 2003 June 25, 2003

OrthoMend™

Abbreviated 510(k) Premarket Notification

K031188/P1/2

510(k) Summarv

This 510(k) summary for OrthoMend is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitted by

TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 (617) 268-1616 (617) 268-3282 (fax)

Contact Person

Kenneth James, Ph.D. Director of Product Development and Applied Research

Date Prepared

June 25, 2003

Device Information

OrthoMend Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)

Device Description

Intended Use

Legally Marketed Devices to which Equivalence is Being Claimed

OrthoMend™ is substantially equivalent in function and intended use to:

Predicate Devices	Manufacturer	510(k) Number
TissueMend SoftTissue Repair Matrix	TEI Biosciences, Boston, MA	K020455
Restore OrthobiologicSoft Tissue Implant	DePuy, Warsaw, IN	K001738

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

TEI BIOSCIENCES INC. June 25, 2003

OrthoMend™

31188

Abbreviated 510(k) Premarket Notification

Summary of Technological Characteristics and Blocompatibility

OrthoMend™ is substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet which can be sutured to surrounding tissues to secure it in place. In addition, the device is fully resorbable over a period of months.

A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of OrthoMend™. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for OrthoMend™ were also tested by an independent laboratory to assure safe levels of viral inactivation.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Kenneth James, Ph.D. Director of Product Development and Applied Research TEI Biosciences, Inc. 7 Elkins Street Boston, Massachusetts 02127

Re: K031188

Trade/Device Name: OrthoMend Regulation Number: 21 CFR 878.3300 Regulation Name: mesh, surgical, polymeric Regulatory Class: II Product Code: FTL Dated: April 8, 2003 Received: April 16, 2003

Dear Dr. James:

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 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 - Kenneth James, Ph.D.

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,

Muram' 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}------------------------------------------------

TEI BIOSCIENCES INC. June 25, 2003

OrthoMend™ Abbreviated 510(k) Premarket Notification

2. Indications for Use of the Device

K031188

510(k) Number (if known):

OrthoMend Device Name:

Indications for Use: OrthoMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery.

(Please do not write below this line-continue on another page if needed)

★ ★ ★ ★ . . . e ▲ t

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Or Over-the-Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109)

Miriam C. Provost

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

510(k) Number K'031188

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.