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The Arthrex Tak™ Family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:

Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
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, Carpal 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
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 Tak™ Family is comprised of titanium alloy implants, poly (L-lactide) or PLLA implants and poly (L-lactide-Co-D, L-lactide) or PLDLA implants. They are offered in several different shapes and sizes. They are offered sterile.

This 510(k) summary (K050749) describes a medical device, the "Arthrex Tak™ Family," which consists of fixation screws for orthopedic applications. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in studies for AI/software devices.

This document is a regulatory submission for a physical medical implant (bone fixation devices) and not an AI or software as a medical device (SaMD). Therefore, the questions related to clinical studies, ground truth, expert consensus, and reader performance with or without AI assistance are not applicable in this context.

The document primarily focuses on:

1. Device Description: The materials (titanium alloy, PLLA, PLDLA) and forms of the implants.
2. Indications for Use: The specific anatomical locations and procedures for which the Arthrex Tak™ Family is intended (e.g., foot, ankle, knee, shoulder, and maxillofacial applications).
3. Substantial Equivalence: The legal and regulatory argument that this device is comparable in safety and effectiveness to predicate devices already on the market. This is the primary method of "proving" its acceptability in a 510(k) submission for this type of device.

Therefore, I cannot provide the requested information for acceptance criteria and study details because this document does not describe such a study for this type of device. The FDA's 510(k) clearance process for physical medical devices like these bone fixation screws relies on demonstrating substantial equivalence to existing predicate devices, rather than conducting a new clinical study to establish performance metrics against specific acceptance criteria in the way an AI/software device would.

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