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The SALVATION External Fixation System is intended for:
• Fusions of the foot including:

• o Triple arthrodesis
• o Isolated hindfoot arthrodesis
• o Midfoot arthrodesis
  o Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio- talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, TMT), metatarsal cuboid
• · Treatment of fractures including:
  o Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient
  o Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or metatarsals (including Jones fractures), ankle, and distal tibia
  o Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/ or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation
• · Reconstruction of deformities including:
• o Neuropathic deformities
• o Charcot reconstruction with or without corrective osteotomies
• o Diabetic Charcot Reconstruction
  o Prevention and treatment of contracture of joints and tendons in equinus
• · Treatment of infected unions, nonunions, or malunions
• · Offloading and or immobilization of ulcers and/or wounds of the foot or ankle
  · Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs and transfers both deep and or superficial around the foot and ankle including posterior tibial, tibialis anterior, flexor digitorum longus, achilles, flexor hallucis longus, peroneus brevis, peroneus longus, extensor hallucis longus, extensor digitorum longus
  · Tumor and neoplasm resection and reconstruction
  • Stabilization associated with rotation flaps, free flaps, muscle flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives
  · Pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal distraction osteogenesis including bone transport
• · Correction of bony or soft tissue deformities
• · Correction of segmental or nonsegmental bony or soft tissue defects
• · Use on long bones including the tibia and fibula
• · Use with or without IM nail in the ankle in Charcot patients

The current SALVATION External Fixation System consists of rings, wires, wire fixation bolts, wire posts with bolts, half pin cubes with bolts, bushings, rocker plates with outsoles, insoles, etc. The Proximal Tibial Ring, Distal Tibial Ring and Foot Ring are designed with slots. This slot feature allows the fixation elements to slide to the desired position as opposed to the user having to handle small components (wire bolt and nut) to attach to the rings or taking the bolt out and placing it into a different hole. The system also includes tab rings with fixation holes to be used based on surgeon preference. As cleared in 510(k) K162033, the SALVATION External Fixation System is designed so that the SIDEKICK Circular and SIDEKICK EZ FRAME™ components are compatible and can be used with the SALVATION External Fixation system.

This document is a 510(k) premarket notification for a medical device called the "SALVATION External Fixation System." It's from the FDA and pertains to mechanical devices designed for bone fixation, not an AI/ML powered device. As such, the information required to answer the questions about acceptance criteria for an AI/ML powered device, such as performance metrics, sample sizes for training and test sets, expert involvement, and ground truth establishment, is not present in this document.

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria based on the provided text. The document focuses on the substantial equivalence of the external fixation system to predicate devices based on mechanical and design characteristics, rather than performance metrics of an AI/ML algorithm.

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