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For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only

Fusion Medical Cannulated Screw System is comprised of screws in diameters 2.0mm (length 10mm-24mm), 2.5mm (length10mm-38mm),3.0mm (10mm-38mm), 5.0mm (length 30mm-70mm), 6.5mm (length 30mm-120mm) standard bone screw. 2.0mm compression (length 20mm-24mm), 2.5mm compression (length10mm-38mm), 3.0mm compression( length 10mm-38mm), 4.0mm compression (length 22mm-56mm), 6.5mm compression (length 30mm- 120mm), 8.0mm compression (length 75mm-140mm) 9.0mm compression (length 75mm-140mm) compression screws. The Screws are made from implant quality Titanium alloy Ti6a14v. (See attachments for thread length, thread pitch and head geometry of screws.) The screws will be machine finished with a 32RMS roughness. K-wires are provided. K wires are made of 316lss. Screwdrivers, drills, and countersinks shanks are made of 17-4-ph stainless steel, condition H 900 heat treated shanks. They are quick connecting shanks that are interchangeable with the handles. Washers are provided. They are made of implant quality Ti6a14v titanium alloy. (See attachment for drawing of the washers and sizes. Depth gauges, and preparation instruments are part of the system.

The provided text is a 510(k) summary for the Fusion Medical Cannulated Screw System, which is a medical device for bone fixation. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.

This document primarily outlines:

• Device Name: Fusion Medical Cannulated Screw System
• Intended Use: Bone fixation in foot, ankle, and hand surgery following trauma or osteotomy.
• Device Components: Descriptions of screws (various diameters and lengths, standard and compression types), K-wires, screwdrivers, drills, countersinks, and washers, including their materials.
• Predicate Device: Fusion Medical Cannulated Screw System (with Osteomed as the predicate's manufacturer, though the phrasing is a bit ambiguous as it says "Equivalence for this devise is based on similarities in intended use; material, design and operational principal to Fusion Medical Cannulated Screw System are the Osteomed"). This suggests the applicant's device is also named Fusion Medical Cannulated Screw System, and it's being compared to a predicate from Osteomed.
• FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and information based on the input text. The document is a regulatory submission approving the device based on substantial equivalence to a predicate, not a detailed study report on its performance against specific acceptance criteria.

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