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The Field Orthopaedics Micro Screw System consists of the following kits with the following indications:

The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.

The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.

The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.

The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.

The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.

Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).

All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).

The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The provided text describes the 510(k) summary for the Field Orthopaedics Micro Screw System and does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/ML device.

The document discusses the mechanical performance of a physical medical device (screws, pins, and K-wires for bone fixation) and compares it to predicate devices based on:

• Mechanical testing: Torsional strength, maximum torque to drive-in and remove screws, and pull-out force, as per ASTM F543.
• Theoretical engineering analyses.
• Simulated surgeon-user testing.

It concludes that the device possesses greater strength than predicate devices and meets the strength requirements for solid screws (ASTM F543).

Therefore, I cannot extract the requested information (such as acceptance criteria table with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for AI/ML models) because this document is about the regulatory submission for a physical orthopedic implant system, not a software/AI/ML medical device.

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