(161 days)
The Arthrex MicroSuture Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist. elbow, and shoulder. Specific indications for use are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand Wrist: Scapholunate Ligament Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendous at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers, Carpal Ligament Reconstruction and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
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 Repairs, Bankart 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique, Ligament Repair, Iliotibial Band Tenodesis.
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 DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm share the same design features, materials, and intended use as the predicates. The anchors are composed of Polyetheretherketone (PEEK) and are preloaded on a driver with nonabsorbable suture. The anchors are provided in a 3.5mm diameter and feature lengths of 8.5 and 13.5mm, respectively.
The provided text is a 510(k) premarket notification for a medical device (suture anchors). It details the device's description, intended use, and its substantial equivalence to previously cleared predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies (like trials or clinical studies), sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.
This type of submission for a Class II device like a bone fixation fastener primarily relies on demonstrating substantial equivalence to a predicate device already on the market. This often involves showing that the new device has similar technological characteristics and performance (e.g., mechanical testing like pull-out strength and torque to failure) when compared to the predicate, rather than conducting new clinical trials or large-scale AI model validation studies as would be described for software as a medical device (SaMD) or AI-driven diagnostics.
Therefore, I cannot extract the requested information to fill in the table or answer the questions related to studies proving acceptance criteria, as such studies are not described in this document.
Based on the provided text, the device is a mechanical bone fixation fastener (suture anchor), not an AI/ML-driven diagnostic or medical imaging analysis device. The regulatory submission focuses on demonstrating substantial equivalence to existing predicate devices through similar design, materials, intended use, and mechanical testing.
Therefore, the detailed questions regarding acceptance criteria, AI model performance, ground truth, expert adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to the content of this document, as it describes a non-AI medical device submission.
The document states:
- "The submitted mechanical testing data demonstrates that the pull-out strength and torque to failure of the proposed devices meets or exceeds that of the predicate devices for the desired indications." This is the core "performance" demonstrated.
- "Any differences between the Arthrex DX SwiveLock SL with Forked Eyelet, 3.5 x 8.5mm and Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm and the predicates are considered minor and do not raise questions concerning safety and effectiveness."
To reiterate, the provided document does not contain the information required to populate the requested table or answer the specific questions about acceptance criteria and studies, as these questions are framed for AI/ML-driven devices or diagnostic tools that involve analyzing data with human oversight, which is not the subject of this 510(k) submission.
§ 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.