Shoulder: Rotator Cuff Repairs, 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: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and 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 Ligament Reconstruction

Device Description

The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a hex molded down the length of the device. The anchor has a hex head, which is seated on a reusable driver for insertion purposes.

AI/ML Overview

This document is a 510(k) summary for the Arthrex Bio-Tenodesis Screw, a medical device intended for fixing sutures to bone. The information provided heavily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than detailed performance study data.

Based on the provided text, it is not possible to fully describe the acceptance criteria and the study proving the device meets those criteria, as much of the requested information (like specific performance metrics, sample sizes for training/test sets, expert details, or study types like MRMC/standalone) is missing from the document.

However, I can extract the available information and highlight what is missing.

Description of the Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The provided 510(k) summary for the Arthrex Bio-Tenodesis Screw focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway typically relies on showing that the new device has the same intended use and technical characteristics as a legally marketed predicate device, or if it has different technical characteristics, it can still be demonstrated to be as safe and effective. The primary "acceptance criteria" in this context are related to demonstrating this equivalence in terms of material properties, mechanical performance (often through bench testing), and safety profile, rather than performance against specific clinical efficacy metrics for a new claim.

The document states: "The differences between the Arthrex Bio-Tenodesis Screw and the predicate devices cited do not raise any questions regarding safety and effectiveness. Furthermore, the material is well characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as the predicate device."

This implies that the acceptance criteria revolved around demonstrating that the new device's material (poly(L-lactide)) and design (hex molded, hex head) perform comparably to predicate devices in relevant tests, and that its intended use is identical.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (as per document)
Intended Use Equivalence: Same indications for use as predicate devices.	Arthrex Bio-Tenodesis Screw is intended for "fixation of suture to bone" for specific indications in Shoulder, Foot/Ankle, Knee, Hand/Wrist, and Elbow. The document states this intended use is "the same" as the predicate device.
Technical Characteristics Equivalence: Material properties and design comparable.	Manufactured from poly(L-lactide), which is "well characterized and has been used in predicate devices with similar indications." Features a "hex molded down the length of the device" and a "hex head" for insertion. The document asserts "differences... do not raise any questions regarding safety and effectiveness."
Safety and Effectiveness Equivalence: As safe and effective as predicate devices.	The primary assertion: "The device, as designed, is as safe and effective as the predicate device." This is a blanket statement, with no specific performance metrics provided in the summary. It relies on the material characterization and the judgment that technical differences do not compromise safety or effectiveness.
Biocompatibility: Poly(L-lactide) material is biocompatible for implant use.	Poly(L-lactide) is cited as "well characterized" and previously used in predicate devices. This implies its biocompatibility is established and accepted.
Sterility: Device is sterile for implantation. (Common implicit requirement)	Not explicitly stated in the provided text, but implied for an implantable device used in surgery. This would typically be demonstrated through validated sterilization methods.
Mechanical Performance: Adequate strength, fixation, and degradation profile.	Not detailed in the summary. Often, non-clinical bench testing (e.g., pull-out strength, torque strength, degradation rate if applicable) is performed to demonstrate equivalence or superior performance to predicates. The summary only implies these aspects were satisfactory by stating "differences... do not raise any questions regarding safety and effectiveness" and that the device is "as safe and effective." No specific quantitative results are provided.

The following information is not provided in the given 510(k) summary:

Sample size used for the test set and the data provenance: Not mentioned. 510(k) summaries often do not detail the specific sample sizes for non-clinical (bench) tests supporting substantial equivalence, nor the provenance of such data. Clinical test sets are generally not required unless new clinical claims are made.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. For a device like a suture anchor, "ground truth" as typically thought of in AI/image analysis studies (e.g., expert consensus on images) is not relevant. The "ground truth" for mechanical equivalence would be established by validated test methods and engineering standards.
Adjudication method for the test set: Not applicable/Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. This type of study is relevant for diagnostic imaging devices involving AI, not for a physical implantable device like a suture anchor.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. Similar to point 5, this is relevant for AI algorithms, not for physical medical devices.
The type of ground truth used: For this device, the "ground truth" would be established by engineering standards and validated test methodologies (e.g., biomechanical testing for pull-out strength, material characterization for degradation profile, adherence to ASTM/ISO standards for material properties). The document does not specify which particular tests or standards were used, only that the material is "well characterized."
The sample size for the training set: Not applicable/Not mentioned. This term applies to machine learning models, not for traditional medical device evaluation in a 510(k).
How the ground truth for the training set was established: Not applicable/Not mentioned.

Summary Gaps:

The 510(k) summary provided is a regulatory document focused on demonstrating "substantial equivalence" to predicate devices. It confirms the device's intended use, general description, and asserts its safety and effectiveness relative to existing marketed devices. However, it lacks the detailed quantitative performance data and study methodologies that would typically be found in a clinical trial report or a comprehensive technical report for a novel medical device. The "acceptance criteria" and "study" are largely inferred from the regulatory pathway of substantial equivalence, where the primary "proof" is the comparison to existing, cleared devices and established material properties.

Summary

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Please amend your 510(k) summary to include a full statement of 4. intended use.

510(k) Summary

510(k) Number:	K010525
Company:	Arthrex, Inc.
Address:	2885 South Horseshoe Drive, Naples, FL 34104
Telephone:	(941) 643-5553
Facsimile:	(941) 435-7191
Contact:	Vernon C. Brown, Manager of Regulatory Affairs
Trade Name:	Arthrex Bio-Tenodesis Screw
Common Name:	Suture Anchor, Tissue Fixation
Classification:	Fastener, Fixation, Biodegradable, Soft Tissue
Product Code:	MAI

Description:

The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a The Antifex Dio renodocio Coron. hex molded down the length of the device. theraces "doolgh with a the device and up the shaft of the driver. The anchor has a hex head, which is seated on a reusable driver for insertion purposes. has a next nead, which is ocated to prepare the bone using a drill of the appropriate size.

Indications for Use:

The Arthrex Bio-Tenodesis Screw is intended for fixation of suture to bone. This product is intended for the following indications:

Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

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Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction

Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The differences between the Arthrex Bio-Tenodesis Screw and the predicate devices cited do not raise any questions regarding safety and effectiveness. Furthermore, the material is well characterized and has been used in predicate The device, as designed, is as safe and devices with similar indications. effective as the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.

Public Health Service

MAY 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K010525

Trade Name: Bio-Tenodesis Screw Regulation Number: 888.3040 Regulatory Class: II Product Code: HWC and MAI Dated: February 22, 2001 Received: February 22, 2001

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) 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.

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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" (21CFR 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark A Mckinan

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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510(k) Number (if known): K010525

Device Name: Arthrex Bio-Tenodesis Screw

Indications for Use:

The Arthrex Bio-Tenodesis Screw is intended for fixation of suture to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repairs, 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
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Reconstruction, Collateral Ligament Ulnar Reconstruction, Ligament Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

. Mark N. Milburn

Division Sign-Off) Division of General, Restorative 8 10 Nourological Devices

(Option Format 3-10-98)

510(k) Number _ K010525

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.