SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery, Muscle flap reinforcement, Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias, Reinforcement of soft tissues repaired by sutures or sutures anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Device Description

SurgiMend is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

AI/ML Overview

This 510(k) premarket notification for SurgiMend Collagen Matrix for Soft Tissue Reconstruction does not contain a study that proves the device meets specific acceptance criteria in the way described in the request. This document is a Summary of Substantial Equivalence, not a clinical study report with performance metrics against acceptance criteria.

The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. It does not typically involve the setting of specific quantitative performance acceptance criteria or a study designed to prove the device meets these criteria in the context of device performance as one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested fields cannot be directly extracted from this document as they are not relevant to a 510(k) submission for a surgical mesh.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not establish or report specific quantitative acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and biocompatibility.

Acceptance Criteria (Quantitative Performance Metric)	Reported Device Performance
Not applicable to this 510(k) submission	Not applicable to this 510(k) submission

The closest the document comes to "performance" is the biocompatibility assessment.

Biocompatibility Assessment:

Criteria: Demonstrated biocompatibility (no cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity).
Reported Performance: "A rigorous biocompatibility assessment performed by an independent laboratory demonstrated the biocompatibility of SurgiMend."
Viral Inactivation: "The manufacturing methods for SurgiMend have also been tested by an independent laboratory to assure appropriate levels of viral inactivation."

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable. This 510(k) submission did not involve a "test set" in the context of evaluating a device's performance against specific metrics using collected data (e.g., patient images or clinical outcomes). The evaluation was primarily a comparison to predicate devices and laboratory biocompatibility testing.
Data provenance: Not applicable in the context of clinical data for performance evaluation. Biocompatibility testing was performed by "an independent laboratory."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" was established for a "test set" in this type of submission. The safety and effectiveness are inferred from the substantial equivalence to predicate devices and biocompatibility testing.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in this 510(k) submission.

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 surgical mesh, not a diagnostic imaging device or an AI-assisted 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 device is a surgical mesh, not an algorithm.

7. The type of ground truth used

Not applicable. No ground truth in the sense of clinical outcomes, pathology, or expert consensus on data was used for performance evaluation of the device in this submission. The "truth" for this submission is related to the established safety and effectiveness of the predicate devices and the direct demonstration of biocompatibility for SurgiMend.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device submission (a surgical mesh).

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: This 510(k) document is a regulatory submission for a surgical mesh, demonstrating substantial equivalence to already approved predicate devices and reporting on standard biocompatibility testing. It does not present a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment as would be required for different types of devices, especially those involving diagnostics or AI.

Summary

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

TEI BIOSCIENCES INC.
8/2/2007

K071807

510(k) Premarket Notification

1/2

AUG -6 2007

510(k) Summary

This 510(k) summary for SurgiMend 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. Vice President, Product Sciences and Regulatory Affairs

Date Prepared

July 31, 2007

Device Information

Proprietary name:	SurgiMend Collagen Matrixfor Soft Tissue Reconstruction
Classification name:	Surgical Mesh
Device classification:	Class II

Device Description

Intended Use

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

Plastic and reconstructive surgery ●
Muscle flap reinforcement .
Hernia repair including abdominal, inguinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
Reinforcement of soft tissues repaired by sutures or sutures . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles,

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

KC718C7

TEI BIOSCIENCES INC. 8/2/2007

SurgiMend 510(k) Premarket Notification

biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Legally Marketed Devices to which Equivalence is Being Claimed

SurgiMend is substantially equivalent in function and intended use to:

Predicate Device	Manufacturer	510(k) Number
OrthoMend	TEI Biosciences	K051766
CosMatrix	TEI Biosciences	K060829
TissueMend	TEI Biosciences	K020455
OrthADAPT	Pegasus Biologics	K071065

Summary of Technological Characteristics and Biocompatibility

SurgiMend is substantially equivalent to other surgical meshes with respect to its design and intended use.

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

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

Public Health Service

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TEI Biosciences, Inc. % Kenneth James, Ph.D. VP. Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127

AUG - 6 2007

Re: K071807

Trade/Device Name: SurgiMed Collagen Matrix for Soft Tissue Reconstruction Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: June 26, 2007 Received: July 9, 2007

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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milkeren

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K071807

TEI BIOSCIENCES INC. 8/2/2007

SuraiMend 510(k) Premarket Notification

Indications for Use

510(k) Number (if known):

Device Name: SurgiMend Collagen Matrix for Soft Tissue Reconstruction

Indications for Use:

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

Plastic and reconstructive surgery .
Muscle flap reinforcement .
Hernia repair including abdominal, inquinal, femoral, . diaphragmatic, scrotal, umbilical, and incisional hernias
Reinforcement of soft tissues repaired by sutures or suture . anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. SurgiMend is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

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)

Mark A. Mcllhenny

(Division Sign-Of Division of General, Restorative,

510(k) Number

13 -

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.