The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair

· Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair

· Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment

· Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction

Device Description

The Stabilynx PEEK Suture Anchor consists of an ethylene oxide sterilized, implantable, poly-ether-etherketone (PEEK) bone screw and ultra high molecular weight polyethylene (UHMWPE) suture anchor is supplied pre-mounted on a disposable Insertion Tool, which consists of a non-patient contact, acrylonitrile butadiene styrene (ABS) handle molded over an externally-communicating, stainless steel shaft. The anchor comes pre-loaded with two (2) high-strength, polyethylene, non-absorbable sutures. The Stabilynx PEEK Suture Anchor design allows a surgeon to create at least one contiguous suture link between one or more adjacent suture anchors after the suture anchors have been inserted into bone. The suture anchor is designed such that one or both of the pre-loaded sutures may be exchanged with one or more sutures connected to an adjacent suture anchor(s).

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Stabilynx PEEK Suture Anchor." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner you might expect for an AI algorithm or diagnostic tool.

Instead, the "acceptance criteria" here refer to various performance metrics and standards that the device must meet to demonstrate its safety and effectiveness, primarily through bench testing, biocompatibility testing, sterilization data, and packaging/shipping validation. The "study" proving the device meets these criteria is the collection of these tests.

Here's the information extracted from the provided text, structured according to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance
Bench Testing	Dimensional and Visual Inspections	Not explicitly stated, but implies meeting design specifications and visual quality.	"Passing results were obtained for all design verification tests."
	Suture Loop Exchange Force	Not explicitly stated.	"Passing results were obtained for all design verification tests."
	Fixation Strength (with and without Cycle Loading)	Not explicitly stated.	"Passing results were obtained for all design verification tests."
	Inserter and Anchor Torque Strength	Not explicitly stated.	"Passing results were obtained for all design verification tests."
	Suture Knot-Pull Tensile Strength	Not explicitly stated.	"Passing results were obtained for all design verification tests."
	Repair Suture Bifurcated Loop Strength	Not explicitly stated.	"Passing results were obtained for all design verification tests."
	Accelerated Aging (3 months equivalent)	Performance maintained after accelerated aging.	"Passing results were obtained for all design verification tests."
Biocompatibility Testing	Cytotoxicity, Systemic Toxicity	Compliance with ISO 10993-1 and FDA guidance for biological evaluation.	"The biocompatibility evaluation for the Stabilynx PEEK Suture Anchor was conducted in accordance with the requirements defined in ISO 10993-1..." (Implies successful completion within limits).
Sterilization Data	Sterility Assurance Level (SAL)	SAL of 10⁻⁶	"The sterilization cycle ensures a SAL of 10⁻⁶."
	Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals	Below limits specified in ISO 10993-7.	"The EO and ECH residuals were below the limits specified in the standard."
	Compliance with ISO 11135-1	Compliance with requirements for EO sterilization process.	"The sterilization parameters...comply with the requirements prescribed in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2007...)"
Packaging and Shipping Validation	Seal Peel (ASTM F88)	Meeting ASTM F88 standards.	"All tests results met the acceptance criteria."
	Bubble Emission (ASTM 2096-11)	Meeting ASTM 2096-11 standards.	"All tests results met the acceptance criteria."
	Simulated Transport (ASTM D4169-09)	Meeting ASTM D4169-09 standards.	"All tests results met the acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not provide specific sample sizes for each bench test, biocompatibility test, sterilization, or packaging validation. It refers generally to "units" or "devices." This document refers to the data as "performance data" and "bench testing," which implies laboratory-generated data rather than human patient data.

Sample Size: Not specified for individual tests.
Data Provenance: Laboratory test data. The country of origin and retrospective/prospective nature are not applicable in the context of these specific tests, as they are engineering and biological evaluations rather than clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. Since this is a physical medical device (suture anchor), "ground truth" is established through physical and chemical measurements against defined engineering and biological standards, not through expert interpretation of medical images or patient outcomes.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human expert review (e.g., for AI model ground truth establishment). The tests described are laboratory-based and follow established scientific protocols for data collection and analysis.

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 done. This type of study is relevant for AI-powered diagnostic tools or imaging devices involving human interpretation. The Stabilynx PEEK Suture Anchor is a physical implantable device.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

As mentioned in point 3, "ground truth" in the context of this device's testing is based on:

Engineering specifications and measurements: For dimensional, visual, torque, and strength tests.
Established scientific standards and methods: For biocompatibility (ISO 10993-1), sterilization (ISO 11135-1, ISO 10993-7), and packaging (ASTM guidelines).
Chemical analysis: For EO and ECH residuals.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2014

Stabilynx, Incorporated Mr. Mike Rosenthal Vice President, Engineering Operations 3475-0 Edison Wav Menlo Park, California 94025

Re: K142643

Trade/Device Name: Stabilynx PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 15, 2014 Received: September 17, 2014

Dear Mr. Rosenthal:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Department of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142643

Device Name Stabilynx PEEK Suture Anchor

Indications for Use (Describe)

The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair

· Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair

· Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment

· Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 6: 510(k) Summary (21 CFR § 807.92(c))

I: SUBMITTER INFORMATION

Submitter:	Stabilynx, Inc.3475-0 Edison WayMenlo Park, CA 94025
Contact:	Mike RosenthalVice President, Engineering Operations, StabilynxPhone: 650.503.3329Fax: 650.618.1440Email: mrosenthal@d3dc.com
Date Summary Prepared:	15 September 2014

II: SUBJECT DEVICE INFORMATION

Device Trade Name:	Stabilynx PEEK Suture Anchor
Common Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener(21 CFR §888.3040)
Product Code:	MBI

III: PREDICATE DEVICE INFORMATION

Stryker PEEK Zip Suture Anchor (K070758) Predicate Device:

No recalls, market withdrawals or safety alerts were identified in FDA's database for the above referenced predicate device.

No reference devices were used in this submission.

IV: DEVICE DESCRIPTION:

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V. INDICATIONS FOR USE:

The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:

. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair
. Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair
. Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment
. Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The primary technological principle for the subject and predicate devices is to anchor suture to bone so that the suture may be used to secure soft tissue to bone. The subject and predicate devices accomplish this function by similar means. At a high level, the subject and predicate devices are based on the following same technological elements:

. PEEK implantable bone screw and non-absorbable sutures
Ability to secure soft tissue to bone during reconstructive procedures

The following technological differences exist between the subject and predicate devices:

Sutures in the subject device contain suture loops at either end
Suture loops of the subject device enable contiguous linking of adjacent suture anchors

VII. PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Verification tests included: a) Dimensional and Visual Inspections; b) Suture Loop Exchange Force; c) Fixation Strength with and without Cycle Loading; d) Inserter and Anchor Torque Strength; e) Suture Knot-Pull Tensile Strength; and, f) Repair Suture Bifurcated Loop Strength. These tests were conducted on ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to three (3) months. Passing results were obtained for all design verification tests.

Biocompatibility Testing

The biocompatibility evaluation for the Stabilynx PEEK Suture Anchor was conducted in accordance with the requirements defined in ISO 10993-1 "Biological Evaluation of Medical Devices" and FDA's guidance ("Use of International Standard ISO 10993", draft document issued on 24 April 2013 and BlueBook Memorandum #G95-1 dated 01 May 1995). Testing included the following: 1) Cytotoxicity; and, 2) Systemic Toxicity. The device is comprised of: 1) an inserter shaft that is considered a tissue/bone

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contacting component for a duration of < 24 hours; and, 2) a bone anchor and suture that are considered permanent implants.

Sterilization Data

The sterilization parameters for the Stabilynx PEEK Suture Anchor device comply with the requirements prescribed in the applicable standards for ethylene oxide sterilization (ISO 11135-1:2007 "Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" and ISO 10993-7:2008 "Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals"). The sterilization cycle ensures a SAL of 10 °. The EO and ECH residuals were below the limits specified in the standard.

Packaging and Shipping Validation

Packaging and shipping validation studies were successfully conducted on sterilized Stabilynx PEEK Suture Anchors pursuant to the applicable ASTM guidelines. These tests included seal peel and bubble emission tests at baseline and T= 3 months. Tests were conducted pursuant to ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"; and ASTM 2096-11 "Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)". Additionally, the ASTM D4169-09 standard was used to evaluate package performance under simulated transport conditions. All tests results met the acceptance criteria.

VIII CONCLUSIONS:

Based on the technological characteristics, indications for use, and bench performance data provided in this premarket notification, the Stabilynx PEEK Suture Anchor Device has a safety and effectiveness profile that is substantially equivalent to the predicate device. The information included in this 510(k) submission demonstrates the same intended use, similar indications for use and technological characteristics of the Stabilynx PEEK Suture Anchor Device as compared to the predicate device. The differences between the subject and predicate devices do not raise different types of safety or effectiveness questions and the performance data demonstrate substantial equivalence.

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.