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The SALVATION(R) External Fixation System is intended for:

· Fusions of the foot including:

Triple arthrodesis O

Isolated hindfoot arthrodesis 0

• 0 Midfoot arthrodesis
  Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talo-calcaneus, O

naviculocuneiform, metatarsal cuneiform (1st, second, third - e.g. Lapidus, TMT), metatarsal cuboid

• Treatment of fractures including:

Treatment of Lis Franc fracture/dislocations in diabetic and Charcot neuropathy patient O

0 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

Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and O or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation

· Reconstruction of deformities including:

• Neuropathic deformities 0
• Charcot reconstruction with or without corrective osteotomies 0
• Diabetic Charcot Reconstruction 0
• Prevention and treatment of contracture of joints and tendons in equinus 0
• · 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 consists of rings, wires, wire fixation bolts, wire posts with bolt, half pins, half pin cubes with bolts, bushings, rocker plates, outsoles, insoles, etc. The Proximal and Distal Tibial Rings and Foot Ring are designed with slots. The SALVATION® External Fixation System features 3 preassembled frame options: 160 MM FRAME with 160 mm proximal tibial ring, 140 mm distal tibial ring, and 140 mm foot ring; 180MM FRAME with 180 mm proximal tibial ring, 160 mm distal tibial and 160 foot ring; and 200 MM FRAME with 200 mm proximal tibial ring, 180 mm distal tibial and 180 mm foot rings. As cleared in 510(k) K150004, 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. The SALVATION™ External fixation system is compatible with the SIDEKICK® EZ FRAMETM External fixation System (K130044) and the SIDEKICK® CIRCULAR Fixator System (K100137).

This document is a 510(k) summary for the SALVATION® External Fixation System. It establishes substantial equivalence to predicate devices and does not describe a study proving the device meets acceptance criteria in the way typically seen for AI/ML devices or diagnostic tools.

Therefore, many of the requested fields cannot be directly answered from the provided text. This document focuses on demonstrating that the device is substantially equivalent to existing, legally marketed devices, rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis.

However, I can extract the relevant information where available and note where information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

This type of structured table for specific, quantifiable performance metrics is not provided in this 510(k) summary because it's for a physical medical device (an external fixation system) seeking clearance based on substantial equivalence, not a diagnostic or AI/ML device requiring performance metrics like sensitivity, specificity, or AUC against acceptance criteria.

The document states:

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices in material, design features, mechanical strength, and indications for use.
• Reported Device Performance: "The SALVATION® External Fixation System is technologically substantially equivalent to predicate devices in material, design features, and mechanical strength. The fundamental scientific technology of the modified device has not changed relative to the predicate devices." (Page 6) and "From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device." (Page 6)

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a physical external fixation system cleared based on mechanical and material equivalence testing and a comparison to existing predicate devices, not a test set of data for an AI/ML algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of AI/ML or diagnostic performance studies, is not established for an external fixation system in a 510(k) process based on substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of data requiring an adjudication method as understood in AI/ML performance studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This device is not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Not applicable in the context of AI/ML or diagnostic studies. For this device, the "ground truth" for its safety and effectiveness is established by comparing its design, materials, and mechanical properties to legally marketed predicate devices which have established their safety and effectiveness through historical use and regulatory review. The non-clinical evidence provided involves engineering analysis.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that undergoes "training."

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/ML model.

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