The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

Device Description

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is an all-inside meniscal repair device. Each device includes two non-absorbable polymer implants, pre-tied with #2-0 non-absorbable suture and pre-loaded into a needle delivery system. The FAST-FIX 360 Meniscal Repair System is provided sterile for single use only.

AI/ML Overview

The provided text describes the FAST-FIX 360 Meniscal Repair System, a suture retention device. However, it does not contain information about acceptance criteria, device performance metrics, a study design with test sets, training sets, expert involvement, or any statistical analysis typically associated with evaluating AI/ML models.

The submission is for a traditional 510(k) medical device that relies on demonstrating substantial equivalence to predicate devices based on design, intended use, fundamental scientific technology, and performance testing for mechanical properties.

Therefore, I cannot fulfill your request for specific details like sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies, as these concepts are not applicable to the information provided in the given texts.

Here's a summary of what is available related to performance, based on the provided text, and an explanation of why other aspects of your request cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Substantially equivalent fixation properties to predicate devices	"Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices."

Explanation: The documentation indicates that the device's performance was evaluated through "Cyclic load and ultimate tensile strength performance testing." The acceptance criterion, implicitly, was to demonstrate "substantial equivalence" to predicate devices (Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N18331)) in these mechanical characteristics. The specific numerical values for these tests or the quantitative thresholds for acceptance are not detailed in the provided text.

Regarding the other aspects of your request:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is not an AI/ML diagnostic or measurement tool. The "testing" referred to is mechanical engineering testing of physical properties, not a clinical study involving 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 mention of "experts" establish a "ground truth" in the context of diagnostic interpretation for this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human interpretation or adjudication.
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 not an AI system, and therefore no MRMC study to compare human readers with and without AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm; it is a physical surgical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a mechanical device is its physical performance parameters (e.g., tensile strength, cyclic load capacity) as measured in a lab.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML model for this device.
9. How the ground truth for the training set was established: Not applicable. See above.

Summary

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SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

FAST-FIX 360 Meniscal Repair System

Date Prepared: 24 NOV 2009

A. Submitter's Name:

JAN 9 8 2010

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Julie Acker, RAC

Senior Regulatory Affairs Specialist

Phone: (508) 261-3618

FAX: (508) 261-3620

C. Device Name

Trade Name:	FAST-FIX 360 Meniscal Repair System
Common Name:	Suture Retention Device
Classification Name:	Suture Retention Device/Synthetic NonabsorbablePolyethylene Suture
Product Code:	GAT
Regulation Number:	21 CFR §878.5000
Device Class	II
Panel	General & Plastic Surgery

D. Predicate Devices

The Smith & Nephew FAST-FIX 360 Meniscal Repair Systems is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N18331)

E. Description of Device

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K092508
pg 2082

F. Intended Use

G. Comparison of Technological Characteristics

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is substantially equivalent in design, intended use and fundamental scientific technology to the predicate devices defined in this submission. The proposed devices have been demonstrated to be substantially equivalent and raise no new issues of safety and efficacy.

H. Summary Performance Data

Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Julie Acker, RAC Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

JAN 2 8 2010

Re: K092508

Trade/Device Name: FAST-FIX 360 Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 24, 2009 Received: November 27, 2009

Dear Ms. Acker:

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 - Ms. Julie Acker, RAC

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/ucm115809.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 yours,
Mark McMillan

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

Enclosure

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K092508

Indications for Use

510(k) Number (if known):

Device Name: FAST-F1X 360 Meniscal Repair System

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use · (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092508

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). 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.