(46 days)
The Arthrex TightRope II devices are intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
The Arthrex TightRope II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with holes to permit suture passage and assembly with Arthrex sutures.
This document is a 510(k) premarket notification for a medical device called the "Arthrex TightRope II". It details the submission to the FDA for expanding the indications for use of this device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:
Crucially, the provided document DOES NOT contain the type of detailed information typically found for the evaluation of AI/ML-based medical devices or diagnostic tools. This document is for a mechanical fixation device (a bone/soft tissue fastener). Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," "ground truth establishment by experts" etc., are not applicable to this type of device submission.
The "Performance Data" section in the document clearly states: "Based on cyclic displacement and strength testing, the proposed Arthrex TightRope II device is equivalent to the predicate Zimmer-Biomet ToggleLoc™ device." This indicates the device's performance was evaluated through mechanical testing, not through clinical studies involving expert interpretation of images or AI algorithm performance.
Given this context, I will address the relevant parts of your request based on the information available in the provided document and explicitly state where the requested information is not applicable.
Device Name: Arthrex TightRope II
Type of Device: Smooth or Threaded Metallic Bone Fixation Fastener
Purpose of Submission: Expand device indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a mechanical fixation device, the "acceptance criteria" are related to mechanical properties and equivalence to a predicate device, not diagnostic performance metrics.
| Acceptance Criteria (Implied from "Performance Data") | Reported Device Performance |
|---|---|
| Mechanical Equivalent to Predicate Device | Demonstrated equivalence to the predicate Zimmer-Biomet ToggleLoc™ device based on cyclic displacement and strength testing. This equivalence supports the proposed expanded indications for soft tissue repairs and reconstructions in the knee. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of devices tested, but the evaluation methods are described as "cyclic displacement and strength testing." This implies testing a sufficient number of physical devices or components to establish mechanical properties.
- Data Provenance: The tests were conducted internally by Arthrex Inc. or a contracted lab. No specific country of origin for data (as in patient data) is relevant here, as it's a mechanical device study. It's a proprietary test conducted by the manufacturer to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a mechanical device, not a diagnostic or AI device requiring expert interpretation for ground truth. The "ground truth" here is the established mechanical performance standards and equivalence to the predicate device, determined through material science and engineering testing.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Mechanical testing does not involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic imaging systems evaluated with human readers, often with AI assistance. It is not applicable to a mechanical bone fixation fastener.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This refers to the standalone performance of an AI algorithm. It is not applicable to this mechanical device.
7. The Type of Ground Truth Used
- Mechanical Performance Standards & Predicate Equivalence: The "ground truth" for this device's performance evaluation is its mechanical behavior (e.g., strength, displacement under load) as measured against engineering standards and in comparison to the well-established predicate device (Zimmer-Biomet ToggleLoc™).
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of AI/machine learning. Its design and validation rely on engineering principles, materials science, and mechanical testing, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of the study that proves the device meets acceptance criteria:
The study proving the device meets its acceptance criteria involved mechanical testing, specifically "cyclic displacement and strength testing." The goal was to establish "equivalence" of the proposed Arthrex TightRope II device to the predicate device, Zimmer-Biomet ToggleLoc™. This type of testing assesses the physical properties and performance characteristics of the implantable medical device under simulated physiological conditions. The manufacturer, Arthrex Inc., performed these tests to demonstrate that the expanded indications for use (MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population) are supported by the device's equivalent mechanical performance to a device already cleared for similar applications.
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August 8, 2023
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Arthrex Inc. Kristi Frisch Regulatory Affairs, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K231857
Trade/Device Name: Arthrex TightRope II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 21, 2023 Received: June 23, 2023
Dear Kristi Frisch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex TightRope II
Indications for Use (Describe)
The Arthrex TightRope II devices are intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | June 21, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Kristi Frisch |
| Title: Regulatory Affairs, Principal | |
| Phone: 1-239-598-4302, ext. 73849 | |
| Email: Kristi.Frisch@Arthrex.com | |
| Trade Name | Arthrex TightRope II |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI- Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bonefastener |
| Regulatory Class | II |
| Primary Predicate Device | K130033 Zimmer Biomet ToggleLoc™ |
| Reference Devices | K221128 Arthrex® TightRope II |
| K202581 Arthrex® TightRope II | |
| Purpose of Submission | This Traditional 510(k) premarket notification issubmitted to expand the device indications to include(for the adult population only):1. Medial Collateral Ligament (MCL) Repair andReconstruction;2. Posterior Oblique Ligament (POL) Repair andReconstruction;3. Lateral Collateral Ligament (LCL) Repair andReconstruction;4. Iliotibial Band Tenodesis (IBT); and5. Patella Tendon Repair (PTR) for the ArthrexTightRope II devices cleared under K202581 andK221128 |
| Device Description | The Arthrex TightRope II devices are comprised of asuture loop that may include passing sutures and/ormetallic button. The suture loop and passing suturesare braided nonabsorbable surgical sutures. The buttonis made of titanium with holes to permit suture passageand assembly with Arthrex sutures. |
| Indications for Use | The Arthrex TightRope II devices are intended to beused for fixation of bone to bone or soft tissue to bone,and are intended as fixation posts, a distribution bridge,or for distributing suture tension over areas of ligament |
| or tendon repair. Specifically, Arthrex will be offeringthese devices for ACL/PCL repair and reconstruction forthe adult and pediatric patient population; and MCL,POL, LCL repair and reconstruction, IBT, and PRT for theadult population only. | |
| Performance Data | Based on cyclic displacement and strength testing, theproposed Arthrex TightRope II device is equivalent tothe predicate Zimmer-Biomet ToggleLoc™ device. Thispredicate equivalence supports the inclusion of theproposed indications for soft tissue repairs andreconstructions in the knee for the proposed ArthrexTightRope II devices. |
| Technological Comparison | The proposed Arthrex TightRope II devices have similartechnological characteristics as the predicate devices.The proposed device is comprised of multiple suturesmanufactured using the same materials as thereference predicate. |
| Conclusion | Therefore, based on the intended use, fundamentalscientific technology, and the data provided in thisSpecial 510(k), Arthrex has determined that theproposed Arthrex TightRope II devices in thissubmission are substantially equivalent to the referencepredicate Arthrex TightRope II devices and theperformance of the Zimmer-Biomet ToggleLocpredicate devices. |
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§ 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.