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The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

The Zeta MultiZone SCN Locking Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade titanium alloy.

This 510(k) premarket notification for the Zeta MultiZone SCN Locking Nail does not contain the information required to fulfill your request. The document describes a medical device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include details on:

• Acceptance criteria for device performance.
• Any specific study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

The provided text is a 510(k) summary and the FDA's response letter, which focus on regulatory clearance based on substantial equivalence, rather than detailed performance study reports.

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