(230 days)
The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
• 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, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 – 5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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 PEEK 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.
The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock device, focusing on an additional indication for meniscal root repair. It does not contain information about an AI/ML-driven medical device, but rather a mechanical medical device (a suture anchor). As such, many of the requested categories for AI/ML performance studies are not applicable.
However, I can extract the information relevant to the device's performance testing for its new indication.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing | |
| Ultimate load for meniscal root repair within acceptable range | Ultimate load of Arthrex SwiveLock is within the acceptable range for meniscal root repair. |
| Cyclic displacement for meniscal root repair within acceptable range | Cyclic displacement of Arthrex SwiveLock is within the acceptable range for meniscal root repair. |
| Biocompatibility Testing | |
| Device meets pyrogen limit specifications | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate the device meets pyrogen limit specifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the mechanical or biocompatibility testing. The data provenance is also not specified, as this is a submission to the FDA (USA) and the tests are generally conducted internally or by contract labs.
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)
Not applicable, as this is a mechanical medical device, not an AI/ML device requiring expert ground truth for classification/detection tasks. The "ground truth" here is established by standardized testing methods and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a mechanical medical device.
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, as this is a mechanical medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a mechanical medical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" is defined by established engineering and biomechanical principles, and the acceptable ranges for ultimate load and cyclic displacement are likely derived from cadaveric studies, clinical literature on meniscal root repair, or comparison to predicate devices/established surgical benchmarks.
For biocompatibility, the ground truth is based on recognized consensus standards (EP 2.6.14/USP ) for bacterial endotoxin limits.
8. The sample size for the training set
Not applicable, as this is a mechanical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a mechanical medical device, not an AI/ML device.
§ 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.