The Arthrex Bio-Tenodesis Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, and hand/wrist. Specifically;

Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps 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
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow. Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Device Description

The Arthrex Bio-Tenodesis Screw is manufactured using poly(L-lactide). It is a threaded anchor which is fully cannulated and has a rounded head. The Bio-Tenodesis Screw is available with a reusable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a drill of the appropriate size.

AI/ML Overview

This document is a 510(k) summary for the Arthrex Bio-Tenodesis Screw. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a medical imaging or AI device.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices, which is the primary regulatory pathway for many medical devices, particularly those that are not novel in their fundamental technology or intended use.

Here's an analysis based on the provided text, addressing the points you requested where applicable, and explaining why others are not present:

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

This information is not present in the provided document. For a 510(k) submission based on substantial equivalence for a physical medical implant like a screw, the "acceptance criteria" are not typically presented as a table of performance metrics with specific thresholds and reported values in the same way they would be for a software or AI device.

Instead, the acceptance criteria are implicitly met by demonstrating that the device is as safe and effective as legally marketed predicate devices. This is achieved by showing that:

It has the same intended use.
It has the same technological characteristics, OR
It has different technological characteristics, but these differences do not raise new questions of safety or effectiveness and can be demonstrated to be as safe and effective.

The document states: "The difference [sic] demonstrated to be [sic] device Tenodesis Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate device with similar indications. The device, as designed, is as safe and effective as predicate devices." This statement is the reported "performance" in the context of a substantial equivalence claim.

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

This information is not applicable/not present for this 510(k) submission. A "test set" and "data provenance" are relevant for performance studies, often clinical or analytical, especially for diagnostic or AI-driven devices. For a physical implant like a bio-tenodesis screw seeking substantial equivalence, performance is evaluated primarily through:

Bench testing: Mechanical tests (e.g., tensile strength, torsion, fatigue) to characterize the physical properties of the screw and compare them to predicate devices or established standards. These tests often use a defined number of samples, but the report does not detail the sample sizes for such tests.
Biocompatibility testing: To ensure the material (poly(L-lactide)) is safe for implantation.
Material characterization: Confirming the properties of the PLLA.
Comparison to predicate devices: Relying on the established safety and effectiveness of previously cleared devices with similar materials, design, and indications.

The document does not detail specific sample sizes for any experimental testing. Data provenance in terms of country of origin or retrospective/prospective is not relevant as it's not a clinical data study in the AI/imaging sense.

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/not present. "Ground truth" established by experts is typically for diagnostic devices, especially those involving interpretation of medical images or clinical signs, where an expert consensus defines the true condition. For this implant, ground truth would refer to measurable physical properties or biological responses, not expert interpretation of outputs.

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

This information is not applicable/not present. Adjudication methods are used in clinical studies or studies involving expert interpretation to resolve discrepancies in diagnoses or assessments. This type of submission relies on engineering and material science principles, and comparison to predicate devices, not on interpretation of clinical cases by multiple experts.

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

This information is not applicable/not present. MRMC studies are specifically designed to evaluate the performance of diagnostic systems, particularly those that involve human readers, often with or without AI assistance. The Arthrex Bio-Tenodesis Screw is a surgical implant, not a diagnostic device, and does not involve "human readers" in the context of interpretation.

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

This information is not applicable/not present. This concept applies to AI algorithms or automated diagnostic systems. The Bio-Tenodesis Screw is a physical device, and its function does not involve an algorithm.

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

As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic or AI devices is not directly applicable. For a surgical implant, the "truth" would be based on:

Physical and mechanical properties: Measured against established engineering standards or predicate device specifications.
Biocompatibility: Demonstrated through recognized biological safety tests.
Clinical history of the material: Poly(L-lactide) is a well-characterized biomaterial with a history of safe use in other medical devices.

The document emphasizes the material (poly(L-lactide)) being "well characterized and has been used in predicate device with similar indications." This points to the established safety and performance of the material and similar device designs as the foundation for the "truth" of its safety and effectiveness.

8. The sample size for the training set

This information is not applicable/not present. A "training set" refers to data used to train machine learning models. This device is a physical implant, not an AI or software device.

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

This information is not applicable/not present. As established in point 8, there is no AI "training set" for this device.

Summary for this specific document:

This 510(k) submission for the Arthrex Bio-Tenodesis Screw relies on demonstrating substantial equivalence to predicate devices. This means that instead of presenting novel performance data against specific acceptance criteria (as would be done for a new technology or higher-risk device), the manufacturer argues that the device is as safe and effective because:

It has the same intended use.
Its material (poly(L-lactide)) is well-characterized and has a history of safe use in similar devices.
Its design and technological characteristics are sufficiently similar to predicate devices, or any differences do not raise new safety or effectiveness concerns.

Therefore, many of the requested items (like specific acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies) are not found in this type of regulatory submission because they are not applicable to the substantial equivalence evaluation of a physical implant like the Bio-Tenodesis Screw.

Summary

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APR 0 2 2002

Ko 20043

510(k) Summary

510(k) Number:
Company:	Arthrex, Inc.
Address:	2885 S. Horseshoe Dr., Naples, FL 34104
Telephone:	(941) 643-5553
Facsimile:	(941) 430-3494
Contact:	Ann Waterhouse
Trade Name:	Arthrex Bio-Tenodesis Screw
Common Name:	Suture Anchor
Classification:	Fastener, Fixation, Biodegradable, Soft Tissue

MAI

Description:

Product Code:

Indications for Use:

Shoulder. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps 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
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow. Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

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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 difference domonotrouled to be be a vice Tenodesis Screw and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the material is well characterized and has been used in predicate device with similar indications. The device, as designed, is as safe and effective as predicate devices.

0000006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 2 2002

Ms. Ann Waterhouse Regulatory Affairs Specialist Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104

Re: K020043

Trade/Device Name: Arthrex Bio-Tenodesis Screws, 4.0 mm and 5.5 mm Models Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 4, 2002 Received: January 7, 2002

Dear Ms. Waterhouse:

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 - Ms. Ann Waterhouse

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,
Mark N Millerson

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

Enclosure

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Page 1 of 1

KOLOOFS 510(k) Number (if known):

Device Name:

Asthrex B.b - Tenodes . S

Indications for Use:

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
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, 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. Millerson

(Option Format 3-10-98)

vision Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K020043

000007

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.