The Axya Model 3000 AxyaLoop™ Bio-Absorbable 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

Device Description

The device is designed with a corkscrew style thread 3.0 mm in diameter, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made 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 Model 3000 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.

The Model 3000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

AI/ML Overview

The provided 510(k) summary for the Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the way a clinical or diagnostic performance study would.

This document focuses on establishing substantial equivalence to existing legally marketed devices, primarily through in vitro mechanical testing. The goal of this type of submission is to demonstrate that the new device is as safe and effective as a predicate device, not necessarily to meet pre-defined performance thresholds for diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as they are not relevant to a 510(k) submission based on substantial equivalence and in vitro testing.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from FDA Guidance)	Reported Device Performance
Anchor pull-out strength comparable to predicate device of similar corkscrew geometry.	"The data presented demonstrate that the anchor pull-out force of the Axya Model 3000 AxyaLoop Bio-Absorbable Bone Anchor compared favorably with the predicate device of similar corkscrew geometry."
Predominant failure mode identical to predicate anchor.	"The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor."

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

Sample Size: Not explicitly stated. The document refers to "summaries of in vitro studies" without providing specific numbers of anchors tested.
Data Provenance: The studies were "in vitro," meaning conducted in a lab environment. The country of origin is not specified but is presumably where Axya Medical, Inc. (Beverly, MA, USA) conducted its research. The studies would be considered prospective in the sense that they were designed and executed to generate specific data for the submission, even if it's not a clinical trial.

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

Not applicable. For in vitro mechanical testing, "ground truth" is established by the standardized methods of the test itself (e.g., precise measurement of force, observation of failure mode). There are no human "experts" establishing a diagnostic ground truth in this context.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data with subjective elements, which is not the case for material property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study (MRMC) is for evaluating the impact of a diagnostic tool on human reader performance, typically in imaging or clinical decision-making. The Axya Bone Anchor is a surgical implant, not a diagnostic device.

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

Yes, in spirit. The in vitro mechanical testing essentially represents "standalone" performance of the device's physical properties. It's the performance of the device itself under controlled conditions, not involving human interpretation in a clinical setting.

7. The Type of Ground Truth Used:

Standardized Mechanical Measurements/Observations. The "ground truth" here is objective physical data (e.g., force in Newtons, precise description of fracture or pull-out). This is established by the methods outlined in the "FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996)."

8. The Sample Size for the Training Set:

Not applicable. The concept of a "training set" is relevant to machine learning algorithms. This device is a physical implant, and its development does not involve training data in that sense. Its design and material choices are based on engineering principles and previous experience with similar devices, not a dataset for training an algorithm.

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

Not applicable (as explained in point 8).

In summary: The provided document is a 510(k) summary for a medical device (a bone anchor) seeking market clearance based on substantial equivalence. It provides evidence of compliance with an FDA guidance document through in vitro mechanical testing to compare its performance (pull-out strength and failure mode) to predicate devices. It does not contain information about acceptance criteria or studies related to diagnostic accuracy, multi-reader performance, or algorithm training, as these concepts are not applicable to the nature of this device and its regulatory pathway.

Summary

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

K051983 9'/3

AUG 5 - 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

Axya Medical, Inc. Name: Howard Schrayer Contact: Regulatory Affairs Consultant
100 Cummings Center Address: Suite 444C Beverly, MA 01915
(978) 232 9997 Telephone: (978) 232 - 9998 Fax:
July 21, 2005 Date Prepared

General Device Information

Product Name:	Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor
Classification:	"Biodegradable soft tissue fixation fastener"Product code: MAI Class II

Predicate Devices

Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor [510(k) Number K041698]

Arthrex Inc. BioFASTak™ Suture Anchor Model AR-1324B [501(k) Number K000506]

Description

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

Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text reads 'K051983' followed by '1 2/3'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.

The Model 3000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

Intended Use (Indications)

The Axya Model 3000 AxyaLoop™ Bio-Absorbable 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 Model 3000 Bio-Absorbable Bone Anchor is substantially equivalent to a number of previously cleared devices, including the Axya Model 5000 AxyaLoop Bio-Absorbable Bone Anchor [510(k) Number K041698] and the Arthrex Inc. BioFASTak Model AR-1324B Suture Anchor.

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 Model 3000 AxyaLoop Bio-Absorbable Bone Anchor compared favorably with the predicate device of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor.

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

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

K051983 p³/₃

Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally Axya Mculoar, me. bonovoo that the me clinical applications as the Axya Model 3000 Biomanotod have boom and . The materials from which the Axya device is fabricated have an Absorbable Bono I theneve the nical applications, and devices produced by Axya have been tested in accordance with applicable FDA guidelines.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

↓

Re: K051983 K051983
Trade/Device Name: Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: July 21, 2005 Received: July 25, 2005

Dear Mr. Schrayer:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the arreed predicate devices marketed in interstate for use stated in the enclosure) to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Drug commerce prior to May 28, 1970, the chaculters with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act . The and Cosmetic Act (Act) that to not require appro the general controls provisions of the Act. The You may, therefore, market the device, sucject to use going mishranding and general controls provisions of the Act merade requirement of the security misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aove) mio entire) and in trepulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controls: Extroing may or 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Couc of Pederal Tegarations)
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 Please be advised that FDA s issualice of a substitution with other requirements of the Act
that FDA has made a determination that your device Forel agemes You must that FDA has made a determination that your are res or other Federal agencies. You must
or any Federal statutes and regulations administered by other not listing or any Federal statures and regulations administration and listing (21
comply with all the Act's requirements, including, but not of seguirements as set comply with all the Act s requirements, menames and starting practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); great 800); and if enplicable, the electr CFR Part 807); labeling (21 CFR 1 at 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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

Page 2 - Mr. Howard L. Schrayer

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin markstill equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, normits vour prematket notification. The PDA miding of substanted by 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 extitled If you desire specific advice for your car (240) 276-__. Also, please note the regulation entitled, comact the Office of Complanoo at (210) 276 - 17 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtai "Misbranding by reference to premance nouthead.org the Act from the Division of Small
other general information on your responsibilities under the Act from the 1900 C28, 000 other general information on your responsion.iss and of its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Plastianse and Constitutions try/support/index.html.

Sincerely yours,

Stipt Rlrodu

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Axya, Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor

Indications For Use:

The Axya Model 3000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing The Axya Model 5000 / kyazoop - dee in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromo-Shoulder: Rotator cun, Dankart, and SEAR 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

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)

Division of General, Restorative, and Neurological Devices

510(k) Number K051983

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.