SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or 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. SportMesh™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Device Description

SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a surgical mesh device, not an AI/ML medical device. Therefore, a direct application of the requested acceptance criteria for AI algorithms is not possible. The document focuses on demonstrating substantial equivalence to predicate devices through material composition, intended use, and performance data, rather than AI performance metrics.

However, I can extract the information relevant to the device's "performance" as presented and the study that "proves" it meets the criteria, reinterpreting the request for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Analogous to Predicate Device Characteristics)	Reported Device Performance (SportMesh™/Artelon® Tissue Reinforcement)	Study/Method
Biocompatibility Safety (per ISO 10993 standards)	Demonstrated appropriate biocompatibility.	Biocompatibility safety studies conducted and successfully completed (ISO 10993 standards). Specific metrics not detailed but implied to meet standards.
Mechanical Properties (for soft tissue repair)	Provides appropriate mechanical properties for its use in soft tissue repair. (Supports reinforcement, but not full mechanical strength, relying on sutures/anchors for primary strength).	Mechanical testing conducted in accordance with "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance." Specific metrics (e.g., tensile strength, elasticity) are not detailed but results are stated to be "appropriate."
Material Composition (identical to predicate)	Identical to predicate Artimplant's SportMesh™ (K052830) in material composition (Artelon® fibers).	Direct comparison of material specifications with predicate device.
Indications for Use (shared with predicate devices)	Each indication for use shared by one or more predicate devices. Intended for reinforcement of soft tissue where weakness exists, including specific tendon repairs (rotator cuff, patellar, Achilles, biceps, quadriceps).	Comparison of intended use statements with predicate devices.
Overall Equivalence (to predicate devices)	Substantially equivalent to legally marketed predicate devices and presents no new concerns of safety and effectiveness.	Conclusion based on a collection of tests (biocompatibility, mechanical) and comparison to predicate devices.

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

This information is not provided in the document. For a physical medical device like this, the "test set" would refer to the samples of the device itself undergoing testing. The document states "A collection of tests has been conducted," but does not specify the number of samples for biocompatibility or mechanical testing. Data provenance is also not specified beyond the general statement that tests were conducted.

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

This concept is not applicable to this type of device submission. Ground truth for a physical medical device typically comes from objective measurements in a lab setting (e.g., mechanical testing, chemical analysis) or animal/human studies for biocompatibility, not expert consensus in the way it's used for AI models to interpret images or other data.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used in AI performance studies to resolve disagreements among human labelers for establishing ground truth, a process not described here for a surgical mesh.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI systems where the AI's impact on human reader performance is being evaluated. This document pertains to a physical surgical mesh.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This term specifically refers to the performance of an AI algorithm without human involvement, which is not relevant to a surgical mesh.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

Objective Laboratory Measurements: For mechanical properties (e.g., tensile strength, degradation rate – though not explicitly listed as specific metrics, implied by "appropriate mechanical properties").
Standardized Biocompatibility Assays: According to ISO 10993 standards. This involves in vitro and in vivo tests to assess material interaction with biological systems.
Material Characterization: Chemical composition and structural analysis to confirm it's "identical" to the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable to this type of device submission. "Training set" refers to data used to train an AI model.

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

This concept is not applicable to this type of device submission.

Summary

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SECTION 5. 510(K) SUMMARY

In accordance with 21 CFR 878.3300, the following information constitutes Artimplant AB's summary for the SportMeshTM /Artelon® Tissue Reinforcement.

A. SUBMITTER INFORMATION

SUBMITTER'S NAME: Artimplant AB Hulda Mellgrens gata 5. SE-421 32 Västra Frölunda. Sweden ADRESS: CONTACT PERSON: Ajrulla Zuta TELEPHONE NUMBER: +46 31 7465600 FAX NUMBER: +46 31 7465660 DATE OF SUBMISSION: 07/06/2007 ESTABLISHMENT REGISTRATION NUMBER: 3004878714

B. DEVICE IDENTIFICATION

DEVICE TRADE NAME: DEVICE COMMON NAME: CLASSIFICATION NAME: CLASSIFICATION REGULATION: REGULATORY CLASS: PRODUCT CODE: ADVISORY PANEL:

SportMeshTM, Artelon® Tissue Reinforcement Surgical Mesh Surgical Mesh, Polymeric 21 CFR 878.3300 Class II FTL General and Plastic Surgery

C. PREDICATE DEVICES

SportMesh™M Artelon® Tissue Reinforcement is substantially equivalent to:

· K042809; CuffPatchTM, Organogenesis Inc
· K071065; OrthADAPTM Bioimplant, Pegasus Biologics
· K053562; Zimmer® Collagen Repair Patch, Tissue Science Laboratories
· K052830; SportMeshTM, Artimplant AB

D. DEVICE DESCRIPTION:

E. INTENDED USE:

SportMesh™/ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons,

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles,

Artimplant

ર્ભ SportMesh™/ Artelon® Tissue Reinforcement 510(k)

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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. SportMesh™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

SportMesh™/ Artelon® Tissue Reinforcement is identical to the predicate Artimplant's SportMesh™ (K052830) with respect to its material composition. Each of the indications for use of the SportMesh™ Artelon® Tissue Reinforcement device are shared by one or more of the predicate devices. Performance data demonstrate that SportMesh™/ Artelon® Tissue Reinforcement is technologically equivalent to one or more of the predicate devices, and that the SportMesh™ Artelon® Tissue Reinforcement demonstrates performance characteristics that are equivalent to the predicate devices. Therefore, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to the predicate devices for the specified indications.

G. PERFORMANCE DATA

A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance. The results demonstrate that SportMesh™Artelon® Tissue Reinforcement provides appropriate mechanical properties for its use in soft tissue repair.

H. CONCLUSION

Based on comparison to the predicate devices, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to legally marketed devices and presents no new concerns of safety and effectiveness.

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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 consists of a stylized eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2007

Artimplant AB % M Squared Associates, Inc. Terry Sheridan Powell 719 A Street, Northeast Washington, District of Columbia 20002

Re: K071887

Trade/Device Name: SportMesh" /Artelon® Tissue Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 6, 2007 Received: July 9, 2007

Dear Ms. Clark:

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.

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Page 2 - Terry Sheridan Powell

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 vours.

Mark A. Millhiser

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

Enclosure

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SECTION 4. INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K 5 7 887 to be assigned

Device Name: SportMesh™/ ArteIon® Tissue Reinforcement

Indications for Use:

SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Subpart C)

(21 CFR 807

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

Over-The-Counter Use _

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millenson

510(k) Number

Page 1 of __ 1_

Artimplant

SportMesh™/ Artelon® Tissue Reinforcement 510(k) 5

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.