Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar

Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ultar or Radial Collateral Ligamant Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Device Description

The Bio-Absorbable Corkscrew Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with two strands of #2 braided polyester suture insert molded through the center of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, the free ends of the suture are used to reattach soft tissue to the bone.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Arthrex Bio-Absorbable Corkscrew Suture Anchor." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document describes a physical medical device (suture anchor) and its intended use, not an AI/ML-driven software device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific aspects (like MRMC studies, standalone performance, training sets, etc.) is not applicable to this submission.

The 510(k) summary focuses on demonstrating that the Bio-Absorbable Corkscrew Suture Anchor is substantially equivalent to predicate devices based on its intended use and technological characteristics, and that it doesn't raise new questions of safety and effectiveness.

Here's why the AI/ML-specific questions are not applicable:

No AI/ML Component: The device described is a physical implant made of poly (L, DL-lactide) with braided polyester suture. It does not involve any software, algorithms, or machine learning.
Substantial Equivalence Pathway: The 510(k) pathway for this type of device primarily involves demonstrating equivalence to existing legally marketed devices, rather than establishing de novo safety and effectiveness through clinical trials with specific performance metrics akin to AI/ML diagnostics.
Lack of Performance Metrics: The document does not describe performance metrics like sensitivity, specificity, accuracy, or AUC, which are common for AI/ML devices. Instead, it refers to the material being "well characterized" and having been used in a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth types in the context of an AI/ML device, as this information is not present nor relevant to the provided text.

The document states:

"The differences between the Bio-Absorbable Corkscrew and the predicate devices cited do not raise any different questions regarding safety and effectiveness."
"Furthermore, the material is well characterized, and has been used in a predicate device with a similar indication."
"The device, as designed, is as safe and effective as the predicate devices."

This indicates that the "acceptance criteria" for this 510(k) was demonstrating substantial equivalence to predicate devices based on material characteristics, design, and intended use, rather than specific quantitative performance metrics derived from a study like one would describe for an AI/ML product.

Summary

{0}------------------------------------------------

K990987

JAN 1 3 2000

510(k) Summary

1052

01/12/00

Company:	Arthrex, Inc.
Address:	2885 S. Horseshoe Drive, Naples, FL 34104
Phone:	(941) 643-5553
Fax:	(941) 643-6218
Contact:	Vernon C. Brown
	Manager of Regulatory Affairs (ext. 117)

Trade Name:	Arthrex Bio-Absorbable Corkscrew Suture Anchor
Common Name:	Suture Anchor
Classification:	Fastener, Fixation, Biodegradable, Soft Tissue

Description:

Intended Use:

The Bio-Absorbable Corkscrew Suture Anchor is intended for fixation of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ultar or Radial Collateral Ligamant Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and

{1}------------------------------------------------

K990787 20
2

different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.

The differences between the Bio-Absorbable Corkscrew and the predicate devices cited do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in a predicate device with a similar indication. The device, as designed, is as safe and effective as the predicate devices

{2}------------------------------------------------

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 depiction of a bird or abstract human figure with three curved lines forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Vernon C. Brown Manager of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K990987 Bio-Absorbable Corkscrew Regulatory Class: II Product Code: MAI and HWC Dated: October 11, 1999 Received: October 19, 1999

Dear Mr. Brown:

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 against 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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.

{3}------------------------------------------------

Page 2 - Mr. Vernon C. Brown

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Russell Sager

Gr James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K990987

Indications for Use

The Bio-Absorbable Corkscrew is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair. Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

Neville Sawyer Sutor

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.