Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy

Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

Device Description

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.

AI/ML Overview

Here’s a breakdown of the acceptance criteria and study information for the SUTUREFIX Ultra Suture Anchor, based on the provided text:

Important Note: The provided text is a 510(k) premarket notification summary. This type of submission generally focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical efficacy studies against acceptance criteria like you'd find for novel therapies or AI-driven diagnostic tools. Therefore, much of the requested information (especially regarding AI, human readers, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not present in this document. The document primarily discusses mechanical performance data.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Insertion Strength Met	Met performance specifications for insertion strength
Pull-out Strength Met	Met performance specifications for pull-out strength
Substantial Equivalence to Predicate Devices	Considered substantially equivalent to currently marketed predicate devices, raising no new issues of safety and efficacy.

Explanation: The document states, "Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices." This implies that the 'acceptance criteria' were the successful demonstration of adequate insertion and pull-out strength, and the ultimate acceptance criterion was deemed 'substantially equivalent' to the predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "Performance data" but does not quantify the number of devices or tests performed.
- Data Provenance: Not specified, but generally, such biomechanical testing would be conducted in a laboratory setting (e.g., in-vitro or ex-vivo testing). No information on country of origin for the data is provided, nor whether it was retrospective or prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a mechanical device like a suture anchor, ground truth is typically established through direct physical measurement and engineering standards, not through "expert consensus" in the medical diagnostic sense. There are no "experts" establishing a diagnostic ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. This is a biomechanical performance study, not an interpretative one.
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 implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement data is relevant or provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biomechanical Performance Metrics: Ground truth for this device would be based on empirically measured physical properties, such as the force required for insertion and the force required to pull out the anchor from a test material (e.g., bone surrogate or cadaveric bone). This is determined by engineering and biomechanical testing standards.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.

Summary

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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA T 978-749-1000 F 978-749-1443 www.smith-nephew.com

We are smith&nephew

K122059

page 1 of 2

MAR 1 8 2013

Submitter Information	Contact Information
Smith & Nephew, Inc.150 Minuteman RoadAndover, MA 01810	Anne-Marie KeefeSenior Regulatory Affairs SpecialistPhone: (508) 261-3713Fax: (978) 749-1443

Device Name & Classification
Proprietary Name	SUTUREFIX Ultra Suture Anchor
Common Name	Soft Tissue Fixation Device
Classification Name	Fastener, fixation, nondegradable, soft tissue
Classification Regulation	21 CFR 888.3040
Class	II
Product Code(s)	MBI
Panel	Orthopedic

Device Description

Predicate Devices ·

Manufacturer	Description	Submission Number	Clearance Date
Smith & Nephew, Inc.	BIORAPTOR 2.3 PK Suture Anchor	K121018	June 22, 2012
Biomet, Inc.	JuggerKnot® Soft Anchors	K110145	March 4, 2011

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T 978-749-1000 F 978-749-1443 www.smith-nephew.com

K122059 page 2 of 2

Intended Use

The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

Hip

Hip capsule repair (Acetabular labrum repair/reconstruction)

Shoulder

Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis

Foot and Ankle

Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy

Elbow, Wrist, and Hand

Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

Knee

Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

Technological Characteristics

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the legally marked predicate devices in commercial distribution and raises no new issues of safety and efficacy.

Summary Performance Data

Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 18, 2013

Smith & Nephew, Incorporated % Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K122059

Trade/Device Name: SUTUREFIX Ultra Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 7, 2013 Received: February 12, 2013

Dear Ms. Keefe:

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. Iisting 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

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Page 2 - Ms. Anne-Marie Keefe

device-related adverse events) (21 CFR 803); 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.

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,

Erin DKeith

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known):K122059

SUTUREFIX Ultra Suture Anchor Device Name:

Indications for Use:

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

Hip

Hip capsule repair (Acetabular labrum repair/reconstruction)

Shoulder

Foot and Ankle

Elbow, Wrist, and Hand

Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

Knee

Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis

Prescription Use X __ (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet际圈Ærank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.