Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

Device Description

The device described in this submission is designed with a corkscrew style thread and is available in 3.0mm, 5.0mm and 6.5mm diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor is available as a system together with a thread tap and a placement tool (driver). 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 Nonabsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nydon, USP braided polyester and USP braided polyethylene suture materials.

The Nonabsorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the AxyaLoop™ Nonabsorbable Bone Anchor. It discusses substantial equivalence to predicate devices based on in vitro testing. However, it does not describe studies typically associated with AI/ML devices or diagnostic performance metrics often found in acceptance criteria for such devices (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria relate to the mechanical performance of the bone anchor.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Metric)	Predicate Device Performance / Benchmarks	AxyaLoop™ Nonabsorbable Bone Anchor Performance
Anchor pull-out strength	Comparable to predicate devices	Comparable to predicate devices; predominately the same failure mode.

Explanation: The document states: "The 510(k) Notice contains summaries of in vitro studies that were conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)." and "The data presented demonstrate that the anchor pull-out force of the Axya AxyaLoop™ Nonabsorbable Bone Anchor was comparable to that of the predicate devices of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor."

2. Sample size used for the test set and the data provenance:

The document mentions "in vitro studies" but does not specify the sample size for these tests (e.g., number of anchors tested, number of simulated bone samples).
Data provenance: "in vitro" implies laboratory testing, not human patient data. There is no information on country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. For mechanical performance tests like pull-out strength, "ground truth" is typically established by direct measurement using calibrated equipment, not expert consensus. The "FDA Guidance Document for Testing Bone Anchor Devices" likely outlines the methodology.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept typically applies to human expert review of diagnostic images or clinical cases, not mechanical testing.

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:

No. This is a mechanical device, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

Not applicable. This device is a mechanical bone anchor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For "anchor pull-out strength," the "ground truth" would be the measured force at which the anchor fails or pulls out from the simulated bone, as determined by mechanical testing according to established testing standards (likely referenced in the FDA Guidance Document).

8. The sample size for the training set:

Not applicable. The device is a mechanical bone anchor, not an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for an algorithm is involved.

In summary:

This document describes a medical device clearance based on substantial equivalence to existing predicate devices, primarily through in vitro mechanical testing to demonstrate comparable performance in terms of pull-out strength and failure mode. The evaluation framework is entirely different from what would be expected for an AI/ML-driven diagnostic or assistive device.

Summary

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K060970 page 1/3

JUL - 5 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807,92)

General Company Information

Name:	Axya Medical, Inc.
Contact:	Howard SchrayerRegulatory Affairs Consultant

Address: 100 Cummings Center Suite 444C Beverly, MA 01915
Telephone: (978) 232 - 9997 Fax: (978) 232 - 9998
Date Prepared April 10, 2006

General Device Information

Product Name: AxyaLoop™ Nonabsorbable Bone.Anchor
Classification: "Nondegradable soft tissue fixation fastener" Product code: MBI Class II

Predicate Devices

Axya Medical, Inc Bioabsorbable Bone Anchors - 3mm, 5mm and 6.5mm [501(k) Numbers K051983, K041698 and K051250] respectively

Innovasive Devices Inc. Nonabsorbable 2.8mm and 3.5mm ROC Suture Bone Fastener [501(k) Number K9634021

Description

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Page 2 of

The Nonabsorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

Intended Use (Indications)

The Axya AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

Substantial Equivalence

This submission supports the position that the Axya Nonabsorbable Bone Anchor is substantially equivalent to a number of previously cleared devices, including the the Axya Medical Bioabsorbable bone anchors cleared under 510(k) numbers K051983 (3mm), K041698 (5mm) and K051250 (6.5mm). The material used to fabricate the AxyaLoop™ Nonabsorbable Bone Anchor is the same acetal polymer used in the previously cleared Innovasive Devices Inc. nonabsorbable 2.8mm and 3.5mm ROC Suture Bone Fasteners cleared under 510(k) K963402.

The 510(k) Notice contains summaries of in vitro studies that were 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 AxyaLoop™ Nonabsorbable Bone Anchor was comparable to that of the predicate devices of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor.

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Page 273

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.

Conclusions

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2006

Axya Medical, Inc. % Mr. Howard L. Schraver Regulatory Affairs Consultant 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K060970

Trade/Device Name: AxyaLoop™ Nonabsorbable Bone Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MBI, HWC Dated: June 8, 2006 Received: June 9, 2006

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 10gally 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may altain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index html.

Sincerely vours.

Souleya Buellet

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K060970

Device Name: AxyaLoop™ Nonabsorbable Bone Anchor

Indications For Use:

The AxyaLoop™ Nonabsorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Uinar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

× Prescription Use (Part 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)

Shater: Brelin

510(k) Number K060770

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.