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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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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, subtalar, 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 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, 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 SALVATION® External Fixation System subject devices are aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins in a variety of sizes designed for external fixation of bone in the lower extremity. The implants included in this system are designed to provide versatile fixation options and accommodate variations in patient anatomy for an array of fusions, reconstructions, corrections, and stabilizations. The SALVATION® External Fixation System Line Extension is compatible with Wright's predicate SIDEKICK® predicate systems.

I am sorry, but the provided text primarily contains information about a 510(k) premarket notification for a medical device called the "Salvation External Fixation System." This document is a regulatory submission to the FDA, asserting that the device is substantially equivalent to previously marketed devices.

It does not contain the details typically found in a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices or comparative effectiveness studies. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document is about a mechanical external fixation system, not an AI/ML device, so there are no such performance metrics or acceptance criteria for AI algorithms.
• Sample size and data provenance for a test set: There's no mention of a test set for an algorithm. The "testing" referred to is mechanical performance testing.
• Number and qualifications of experts for ground truth: Not applicable here.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned. The equivalence claim is based on mechanical properties and intended use.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size and ground truth establishment for a training set: Not applicable, as this is not an AI/ML device requiring training data.

The "Substantial Equivalence - Non-Clinical Evidence" section on page 6 mentions "Performance testing and analysis that demonstrated substantial equivalence include static strut testing, dynamic construct testing, and an engineering analysis comparing each subject and predicate component." This refers to biomechanical testing, not clinical performance or AI algorithm validation. The "Clinical Evidence" section explicitly states "N/A" (Not Applicable).

Therefore, based on the provided text, I cannot answer your request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria in the context of AI/ML device validation. The document describes a traditional medical device submission for an external fixation system.

Ask a specific question about this device

Ask a specific question about this device