Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Tornier® Surgical Mesh is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.

Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Device Description

Tornier® Surgical Mesh is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile, for single-patient use for the reinforcement of soft tissue where weakness exists.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Tornier® Surgical Mesh) and does not describe a study involving acceptance criteria for a device performance evaluation in the manner usually associated with AI/software devices (e.g., sensitivity, specificity, accuracy).

Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices primarily through biocompatibility testing and adherence to specific guidance documents for surgical mesh.

Therefore, many of the requested categories for device performance and study design are not applicable to the information provided in this 510(k) summary. I will address the applicable points based on the available text.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence to predicate devices regarding intended use and materials.	The sponsor states: "This submission supports the position that the Tornier™ Surgical Mesh System is substantially equivalent to previously cleared devices..."
Compliance with biocompatibility standards.	"Substantial equivalence has been demonstrated by conduct of applicable biocompatibility testing as outlined in ISO10993."
Adherence to relevant FDA guidance documents for surgical mesh.	"In addition, Tornier has conducted testing consistent with the requirements of the Guidance Document entitled: 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' (March 2, 1999)"
Materials having an established history of use for similar applications.	"The materials from which the Tornier device is fabricated have an established history of use..."
Similar clinical applications as legally marketed devices.	"Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier™ Surgical Mesh System." (This is an assertion of the sponsor, and the FDA's clearance implies agreement based on the provided evidence).
Device performance should be appropriate for its intended use as a temporary support and reinforcement material, not a full replacement for normal body structures or to bear full mechanical strength of tendons. (Implicit in Indications for Use)	The Indications for Use explicitly state these limitations. The device's design (bi-layer, synthetic absorbable woven fabric) and the testing for substantial equivalence supports its role as reinforcement rather than primary mechanical support.

(Note: This 510(k) is about demonstrating substantial equivalence, not establishing new performance benchmarks for a novel device. The "acceptance criteria" are therefore largely about conforming to existing standards and predicate devices rather than achieving specific numerical performance metrics like those for AI algorithms.)

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

This information is not provided in the 510(k) summary. The document mentions "applicable biocompatibility testing" and "testing consistent with the requirements of the Guidance Document," but does not detail the specific sample sizes, methodologies, or data provenance (e.g., in vivo/in vitro, animal studies, country of origin) for these tests.

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 submission. This 510(k) summary does not involve a study that establishes ground truth based on expert consensus for diagnostic or prognostic purposes, as it is for a surgical mesh device.

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

This information is not applicable to this type of submission. There is no diagnostic "test set" in the context of expert adjudication for this device.

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

This information is not applicable to this submission. An MRMC study is relevant for AI-powered diagnostic/interpretive devices, not for a surgical mesh.

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

This information is not applicable to this submission. This device is a physical surgical mesh, not an algorithm.

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

For the biocompatibility and material testing referenced, the "ground truth" would be established by standardized laboratory testing procedures and scientific consensus on material properties and biological responses (e.g., ISO10993 standards). For demonstrating equivalence of clinical applications, the ground truth is the established clinical use and safety profiles of the predicate devices.

8. The sample size for the training set

This information is not applicable to this submission. There is no concept of a "training set" for a physical surgical mesh device in this context.

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

This information is not applicable to this submission.

Summary

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K093799

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510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

4.1

APR 2 2 2010

Tornier, Inc. Name: Contact: Howard Schrayer Regulatory Affairs Consultant
3601 W. 76th Street Address: Suite 200 Edina, MN 55435
Telephone: (978) 232 - 9997 (978) 232 - 9998 Fax:
Date Prepared December 9, 2009

General Device Information

Product Name: Tornier® Surgical Mesh
Classification: "Absorbable Surgical Mesh" Product code: FTL - Class II

Predicate Device

Tepha, Inc.	TephaFLEX™ Surgical Mesh[510(k) Number K070894]
Artimplant AB	Artelon® SportMesh™ Tissue ReinforcementSurgical Mesh[510(k) Number K071887]
LifeCell Corp.	LTM-RC Surgical Mesh[510(k) K071986]

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Description

Intended Use (Indications)

Substantial Equivalence

This submission supports the position that the Tornier™ Surgical Mesh System is substantially equivalent to previously cleared devices, including those listed above. Substantial equivalence has been demonstrated by conduct of applicable biocompatibility testing as outlined in ISO10993. In addition, Tornier has conducted testing consistent with the requirements of the Guidance Document entitled: "Guidance for the Preparation of a Premarket Notification for a Surqical Mesh" (March 2. 1999) A number of predicate devices list the same range of clinical uses.

Conclusions

Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier™ Surgical Mesh System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

APR 22 2010

Tornier, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K093799

Trade/Device Name: Tornier® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2010 Received: April 16, 2010

Dear Mr. Schrayer:

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.

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

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Page 2 - Mr. Howard L. Schrayer

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K093799

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Tornier® Surgical Mesh

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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)

for DKK

Dististince of broical, Orthopedic, and Restor. Tive Devices

510(k) Number: K093799

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.