In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
Female urinary incontinence due to urethral hypermobility;
In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to illotibial band tenodesis:
In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments;
Lateral canthoplasty.

Device Description

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is a single use, sterile device, available in two configurations: the ANCHORLOK™, which is provided sterile, preloaded with suture and a disposable, single use driver, and the ANCHORLOK™ RL, which is provided sterile and is designed for use with reusable, resterilizable driver instrumentation, and suture provided by the surgeon. The anchors for both configurations are made of titanium alloy.

AI/ML Overview

The acceptance criteria and study details for the ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System are provided below, based on the given text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pullout Strength (In vitro)	ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor.

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

The document does not specify the exact sample size used for the in vitro pullout strength testing. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it is an in vitro test, "retrospective" or "prospective" as applied to clinical data isn't directly relevant.

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

This information is not provided in the document. The study described is an in vitro pullout strength test, which typically relies on laboratory measurements rather than expert consensus on a test set in the way a clinical study would.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The study described is an in vitro mechanical test, not a study requiring adjudication of human readings or interpretations.

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

There was no MRMC comparative effectiveness study mentioned. The device is a soft tissue anchor system, not an AI or imaging diagnostic tool.

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

This question is not applicable to the device described. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through in vitro pullout strength testing. This involves subjecting the device to controlled mechanical forces to measure its resistance to being pulled out of a simulated soft tissue material. The performance was then compared to a predicate device.

8. The Sample Size for the Training Set

This information is not applicable and is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a "training set."

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

This information is not applicable. The device is a physical implant, not a machine learning algorithm that requires ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, angled lines that converge at the bottom, creating a triangular shape. A small registered trademark symbol is located at the bottom center of the "W".

Image /page/0/Picture/1 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002". The text is in a sans-serif font and is black on a white background. The text is arranged in a vertical format, with the company name at the top, followed by the address.

K971282

JUN 27 1997

...

510(k) Summary

Contact Person: Date Prepared:

Cristie Manuel April 4, 1997

Classification Name: Predicate Device:

Trade/Proprietary Name: ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System Fastener, fixation, nondegradable, soft tissue ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System manufactured for Wright Medical Technology, Inc., and the Mitek Anchor manufactured by Mitek Surgical Products, Inc.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Description/Intended Use

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:

In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, . acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
. In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
. In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
. Female urinary incontinence due to urethral hypermobility;
In the repair of knee instability secondary to tear or separation of the medial collateral ligament, . lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to illotibial band tenodesis:
. In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments;
. Lateral canthoplasty.

Testing Summary

Conclusion: In vitro pullout strength testing indicates the ANCHORLOK™ RL Anchor can be expected to meet or exceed the pullout strength of the predicate Mitek anchor.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, superimposed over a circular emblem. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christie Manuel 'Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

JUN 27 1997

K971282 Re : Anchorlok and Anchorlok RL Soft Tissue Anchor System Requlatory Class: II Product Codes: MBI and HWC Dated: April 4, 1997 Received: April 7, 1997

Dear Ms. Manuel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Marie Schroeder, MS, PT

M.D. Celia M. Witten, Ph.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Wright Medical Technology, Inc. Premarket Notification

ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System, Expanded Indication

Indications for Use of the Device C.
510(k) Number (if known): _ 长分71282

ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Device Name: Anchor System

Indications for Use:

The ANCHORLOK™ and ANCHORLOK™ RL Soft Tissue Anchor System is intended for use:

In the repair of shoulder instability secondary to Bankart lesion, rotator . cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
In the repair of elbow instability secondary to biceps tendon detachment, . tennis elbow, or ulnar or radial collateral ligament tear/separation;
In the repair of hand/wrist instability secondary to tear or separation of the . scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
Female uninary incontinence due to urethral hypermobility;
In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments:
Lateral canthoplasty

continue on another page if needed) (Please do not write below this line-* *

Concurrence of CDRH, Office of Device Evaluation (ODE)

Man-F. Helmoller MSSt. des Amin

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971282

Prescription Use X (Per 21 CFR 801.109) Or

Over-the-Counter Use

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(Optional Format 1-2-96)

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.