(27 days)
The Arthrex TightRope II devices are intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/ PCL repair and reconstruction for the adult and pediatric patient population; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction.
The proposed Arthrex TightRope II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with hole s to permit suture passage and assembly with Arthrex sutures.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex TightRope II device, which outlines the device's indications for use, technological characteristics, and comparison to predicate devices.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or the number/qualifications of experts used to establish ground truth.
- Information on adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample sizes for training sets or how their ground truth was established.
The "Performance Data" section briefly states that "Based on cyclic displacement/load displacement testing, the proposed Arthrex TightRope II device is equivalent to the Arthrex TightRope II device predicate device." This indicates that some performance testing was done, but it does not provide the specific criteria or detailed study results. The document focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting detailed performance study data against defined acceptance criteria.
§ 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.