(115 days)
The Surgicraft Screw Fixation System and is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tenodesis, Deltoid Repair. Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction. Elbow. Wrist. Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment. Knee: Extra Capsular Repairs - Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament, Illiotibial Band Tenodesis, Patellar Tendon Repair. Pelvis: Bladder Neck Suspension Procedures. Single patient use only
The Surgicraft Screw Fixation System is manufactured from stainless steel and titanium. The self-tapping 3.5 mm screws are available in lengths from 20- 40 mm in 1 mm increments. The washers have an inner hole diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.
The provided text is a 510(k) Summary for the Surgicraft Screw Fixation System. It outlines the device description, intended use, and substantial equivalence to predicate devices, focusing on non-clinical mechanical testing. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/algorithm performance.
Therefore, I cannot populate the requested table and answer the specific questions related to AI/algorithm performance, ground truth, sample sizes for test/training sets, expert qualifications, or MRMC studies.
The document states:
- "Non-Clinical Testing: The Surgicraft Screw Fixation System was tested as follows: • Mechanical Testing ASTM - F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws"
- "Clinical Testing: Not applicable to this device"
This means the device's performance was evaluated through mechanical testing against an ASTM standard, not a study involving AI or human interpretation of medical images/data. The absence of clinical testing further confirms this.
§ 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.