(27 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, Siceps 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 and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of 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.
Hip: Capsular repair, acetabular labral repair. Proximal Hamstring Repair (4/75-5.5 PEEK SwiveLock only).
The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
This provides an analysis of the provided text regarding the Arthrex SwiveLock Anchors.
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the Arthrex SwiveLock Anchors (K190728) describes a comparison to predicate devices, focusing on mechanical performance. The "acceptance criteria" can be inferred from the statement that the device performs "statistically equivalent" to the predicate.
| Acceptance Criteria (inferred) | Reported Device Performance |
|---|---|
| Statistically equivalent cyclic pull-out performance to predicate devices (K180768 Arthrex SwiveLock Suture Anchor and K150768 Zimmer Biomet JuggerKnot Soft Anchor). | Cyclic pull-out testing demonstrated that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate devices. |
| Meets pyrogen limit specifications per EP 2.6.14/USP . | Bacterial endotoxin testing per EP 2.6.14/USP was conducted and demonstrated that the device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was performed."
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a U.S. company (Arthrex Inc., Naples, FL), the testing would typically be conducted in a controlled lab environment, likely in the US or by a recognized testing facility. It would be considered prospective testing for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for mechanical testing of a medical device like a suture anchor is based on objective, quantifiable physical measurements (e.g., force, displacement, material properties) rather than expert opinion or diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. For mechanical testing, the results are typically derived from instrumentation, and judgment or adjudication in that sense is not usually employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for a surgical implant (suture anchor), where performance is assessed through biomechanical testing, not reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was done. The "Performance Data" section describes "Cyclic pull-out testing" and "Bacterial endotoxin testing." These are laboratory-based, objective tests conducted on the device itself without human intervention in the performance measurement process.
7. Type of Ground Truth Used
The ground truth used for the performance data is based on objective, quantitative physical and biological measurements:
- Biomechanical Metrics: For cyclic pull-out testing, the "ground truth" is the measured force-displacement characteristics and failure modes, compared against established performance benchmarks of the predicate devices.
- Physicochemical Analysis: For bacterial endotoxin testing, the "ground truth" is the measured endotoxin level compared against predefined pyrogen limit specifications.
8. Sample Size for the Training Set
This information is not applicable as this device does not involve an AI algorithm that requires a "training set." The device is a physical medical implant whose performance is evaluated through mechanical and biological testing, not by learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no AI algorithm or training set involved with this 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.