(82 days)
The Smith & Nephew TWINFIX PK FP Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair. Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illoiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
The TWINFIX PK FP Anchor is a suture anchor manufactured from PEEK polymer. The pound in anchor is not preloaded with suture, incorporates a two piece anchor body and faciliates arthroscopic repair of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.
The provided text is a 510(k) summary for a medical device (Smith & Nephew TWINFIX PK FP Suture Anchor) and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested.
The document states that "The performance testing conducted demonstrates substantial equivalence to the Arthrex® PushLock™ suture anchor, cleared in K051219. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." However, it does not provide details about what that performance testing was, what acceptance criteria were used, or the results of those tests.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with the provided text. The requested information regarding specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not present in this document.
§ 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.