(168 days)
The Arthrex FiberTak Suture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications 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, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons 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 Collateral Ligament Repair, ● Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Arthrex FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair. The device is provided sterile intended for single use. The anchor is constructed from a hollow braid of polyester. A blue and white striped suture comprised of UHMWPE (white) and Polyester (blue) is assembled through the hollow braid. The striped suture component is designated as TigerWire CL. The device comes preloaded on a disposable inserter. The inserter is made from surgical grade nitinol and ABS plastic. The FiberTak Suture may be sold separately or in a kit with implantation instrumentation.
The provided text describes the Arthrex FiberTak Suture Anchor, a medical device intended for soft tissue fixation. It does not contain information about acceptance criteria for a study that proves the device meets specific performance metrics in the context of an AI/ML or diagnostic device. Instead, the document is a 510(k) premarket notification approval letter for a physical medical device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML study, nor any of the other requested information pertaining to studies for AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.
The document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical testing and similar indications for use.
Here's what can be extracted related to this device approval, but it doesn't align with your request for AI/ML study details:
Device: Arthrex FiberTak Suture Anchor
Purpose of Submission: To obtain clearance for the Arthrex FiberTak Suture Anchor by demonstrating substantial equivalence to a predicate device.
Predicate Device: K112237: Arthrex MicroSuture Anchor
Substantial Equivalence Summary (equivalent to showing device meets certain criteria):
The submission states:
- "The indications for use of the proposed Arthrex FiberTak Suture Anchor are identical to the predicate device."
- "The submitted mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices."
This indicates that the key acceptance criteria for this specific device clearance were:
- Identical Indications for Use as the predicate device.
- Equivalent or superior mechanical performance (specifically "pull-out strength") compared to the predicate device.
The document does not provide:
- A table of specific quantitative acceptance criteria or detailed mechanical test results.
- Sample sizes for mechanical testing.
- Information on "experts" or "ground truth" in the context of diagnostic/AI performance.
- Any details about AI/ML studies (MRMC, standalone, training sets, etc.).
§ 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.