(310 days)
The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 – 5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.Hip: Capsular repair, acetabular labral repair.
The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.
The provided document is a 510(k) summary for the Arthrex SwiveLock Anchors, specifically an amendment to include a new indication for secondary fixation in ACL/PCL reconstruction or repair. This document does not describe a study involving an AI device or a comparative effectiveness study with human readers.
Instead, it focuses on demonstrating substantial equivalence of a medical device (surgical anchors) to previously cleared predicate devices through specific technical and biomechanical testing, rather than clinical performance based on diagnostic accuracy or AI-assisted interpretation.
Therefore, many of the requested fields related to AI performance, human reader studies, and ground truth establishment for a diagnostic algorithm cannot be answered from this document.
However, I can extract information related to the acceptance criteria and the study that demonstrates the device meets these criteria in the context of this 510(k) submission for the Arthrex SwiveLock Anchors.
Here's a breakdown of the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance:
The document states: "Biomechanical testing (ultimate load) was conducted to demonstrate that the use of the SwiveLock as a secondary fixation in ACL reconstruction is greater than a construct without it."
While specific numerical acceptance criteria (e.g., "ultimate load must be > X Newtons") are not explicitly stated as a table in this summary, the acceptance criterion is implicitly "greater than a construct without it". The reported performance is that the SwiveLock did meet this criterion.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ultimate load of construct with SwiveLock as secondary fixation in ACL reconstruction must be greater than a construct without SwiveLock. | The biomechanical testing demonstrated that the ultimate load was "greater than a construct without it." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in this 510(k) summary. Biomechanical testing usually involves a defined number of samples, but the exact count is not provided.
- Data Provenance: The study is described as "biomechanical testing," implying laboratory-based testing rather than clinical data from a specific country. It's a study conducted specifically to support this regulatory submission, not a retrospective or prospective clinical data collection.
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 question is not applicable. For a biomechanical test of a surgical anchor, there isn't "ground truth" derived from expert consensus on diagnostic images. The "truth" is established by the physical testing methods themselves, performed according to established engineering and mechanical testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to adjudication of expert opinions for ground truth establishment in studies involving human interpretation or subjective assessment, which is not the case here.
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:
Not applicable. This is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this type of device and study is the direct measurement of physical properties (ultimate load) under controlled laboratory conditions, following validated biomechanical testing protocols. It's not based on expert consensus, pathology, or outcomes data in the traditional medical sense, but rather on direct empirical evidence from engineering tests.
8. The sample size for the training set:
Not applicable. This is not an AI device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Arthrex, Incorporated Mr. David Rogers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151342 Trade/Device Name: Arthrex SwiveLock Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: February 19, 2016 Received: February 23, 2016
Dear Mr. Rogers:
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 Parts 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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division 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) K151342
Device Name Arthrex SwiveLock Anchors
Indications for Use (Describe)
The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
· Foot/Ankle: Lateral Stabilization. Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
· Hip: Capsular repair, acetabular labral repair
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | November 18, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | David L RogersRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com |
| Trade Name | Arthrex SwiveLock Anchors |
| Common Name | Suture Anchor |
| Product Code, | MAI, MBI |
| Classification Name, CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories |
| Predicate Device | K101823: Arthrex SwiveLock AnchorsK071176: Arthrex Bio Interference Screws |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to include an additionalindication for secondary fixation in ACL/PCL reconstruction or repair for theArthrex SwiveLock Anchors (4.75 - 5.5 sizes). |
| Device Description | The Arthrex SwiveLock Anchor is a two-component, knotless suture anchorcomprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on thedriver shaft. FiberWire suture may also be provided with the device. |
| Intended Use | The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) tobone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing procedures:Shoulder: Rotator Cuff Repair, 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 TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, andIlliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstructionor repair (4.75 – 5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar orRadial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.Hip: Capsular repair, acetabular labral repair. |
| SubstantialEquivalence Summary | The Arthrex SwiveLock Anchors are substantially equivalent to the predicatedevices, in which the basic design features and intended uses are the same. Anydifferences between the Arthrex SwiveLock Anchors and the predicates areconsidered minor and do not raise questions concerning safety and effectiveness.Biomechanical testing (ultimate load) was conducted to demonstrate that the useof the SwiveLock as a secondary fixation in ACL reconstruction is greater than aconstruct without it. |
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Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Arthrex SwiveLock Anchors is substantially equivalent to currently marketed predicate devices.
§ 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.