The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

Foot and Ankle
1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow wrist and Hand
1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

Device Description

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Axya Model 3000 AxyaLoop™ Titanium Bone Anchor:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Mechanical Performance: Anchor pull-out strength equal to or better than a predicate device, as specified in FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996).	The anchor pull-out force of the Axya Model 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device (OBL 2.0 mm Mini Tac). The failure mode observed (anchor pull-out) was the same for both.
Material Biocompatibility: Materials have an established history of use in medical applications.	The materials from which the Axya device is fabricated have an established history of use in medical applications.
Sterilization: Components are provided sterile, and the sterilization process is equivalent to the original suture manufacturer.	The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturer.
Clinical Equivalence: Safe and effective for specific soft tissue to bone repairs in extremities.	Similar legally marketed bone anchors have been used for the same clinical applications.

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

Sample Size for Test Set: The document explicitly states an "in vitro study," but it does not specify the sample size (e.g., number of anchors tested, number of repetitions, or types of bone analogues used).
Data Provenance: The study was an in vitro study. The country of origin for the data is not specified, but given the company's address (Beverly, MA, USA) and the FDA submission, it can be inferred the study was likely conducted in the USA or supervised under US regulatory standards.

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

This information is not applicable as the described study is an in vitro mechanical performance study, not a clinical study involving human expert assessment for ground truth. The "ground truth" here is the physical measurement of pull-out force.

4. Adjudication Method for the Test Set

This is not applicable as the described study is an in vitro mechanical performance study and does not involve human readers or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is a bone anchor, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI comparison was done.

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

This is not applicable. The device is a physical bone anchor, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for the in vitro study was objective mechanical measurement (specifically, pull-out force) following an established FDA guidance document.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" mentioned or implied as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This is not applicable for the same reasons as #8.

Summary

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OCT 0 4 2002

K022207
page 1 of 2

SUMMARY OF SAFETY AND EFFECTIVENESS

General Company Information

Axya Medical, Inc. Name:

100 Cummings Center Address: Suite 444C Beverly, MA 01915
(978) 232 9997 Telephone: (978) 232 - 9998 Fax:

General Device Information

Product Name:	Model 3000 AxyaLoop™ Titanium Bone Anchor
Classification:	"Non-degradable soft tissue fixation fastener", Product code: MBClass II

Predicate Devices

Axya Medical, Inc. Model 1000 AxyaLoop™ Suture Anchor [501(k) Number K003971]

Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor [510(k) Number K000797]

Description

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Indications

Foot and Ankle

1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow wrist and Hand

1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

Substantial Equivalence

This submission supports the position that the Axya Model 3000 Titanium Bone Anchor is substantially equivalent to a number of previously cleared devices, including those referenced above.

The 510(k) Notice contains summaries of an in vitro study that was conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996). The data presented demonstrate that the anchor pull-out force of the Axya Model 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device of similar diameter and corkscrew geometry (OBL 2.0 mm Mini Tac). The failure mode observed for the Axya anchor and the predicate anchor was the same (i.e. anchor pull-out).

The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturer.

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed bone anchors have been used for the same clinical applications as the Axya Model 3000 Titanium Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and the devices produced by Axya have been tested in accordance with applicable FDA guidelines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

OCT 04 2002

Mr. Howard L. Schrayer Axya Medical, Inc. 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K022207

Trade/Device Name: Model 3000 AxyaLoop™ Titanium Bone Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: MBI, HWC, GAS Dated: July 3, 2002 Received: July 8, 2002

Dear Mr. Schrayer:

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 - Mr. Howard L. Schrayer

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Q. Mark A. Milliman

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

Enclosure

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page 1 of 1

KorzioT 510(k) Number (if known):

Device Name: Axya, Model 3000 AxyaLoop™ Titanium Bone Anchor

Indications For Use:

Foot and Ankle

1 Hallux Valgus repairs
2 Medial or lateral instability repairs/reconstructions
3 Achilles tendon repairs/reconstructions
4 Midfoot reconstructions
5 Metatarsal ligament/tendon repairs/reconstructions

Elbow, Wrist and Hand

1 Scapholunate ligament reconstructions
2 Ulnar and radial collateral ligament reconstructions
3 Lateral epicondylitis repair
4 Biceps tendon reattachment

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number __K022207

Prescription Use __ OR Over-The-Counter Use __
(Per 21 CFR 801.109)

(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.