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The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

• Stabilization of soft tissues and fractures
• Polytrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction
• Unilateral rectilinear bone segment transport or leg lengthening

The Cardinal Health External Fixation System consists of rod-to pin clamps, rod-to-rod clamps, rods, pins. Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (316L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber reinforced epoxy. The Cardinal Health External Fixation System is provided non-sterile.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance in a study, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document is a 510(k) premarket notification for the "Cardinal Health External Fixation System," which is a regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria.

Here's what the document does provide:

• Device Name: Cardinal Health External Fixation System
• Indications for Use: Treatment for long bone and pelvic fractures requiring external fixation, including stabilization of soft tissues, polytrauma, pelvic fractures, arthrodeses/osteotomies, neutralization of fractures, non-unions, intra-operative reductions, and leg lengthening.
• Predicate Device: Emerge External Fixation System (K140675)
• Performance Data (Mechanical Testing): The device underwent testing related to MRI safety and compatibility in accordance with ASTM standards (F2182-11a, F2052-06, F2213-11). It states that the device is "safe and compatible in the MR environment as an 'MR Conditional' device." It also mentions that the predicate device included performance testing per ASTM F1541-02 (2001).
• Conclusion on Performance: "In all instances, the External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device." However, the specific acceptance criteria themselves for the functional performance (beyond MRI safety) are not detailed in this document.
• Substantial Equivalence Basis: Intended use, basic design, materials, sizing, and performance.

Therefore, I cannot fulfill your request for the specific table, sample sizes, expert details, adjudication methods, MRMC study information, or standalone algorithm performance data as this type of information is not present in the provided text. The document describes a regulatory filing based on mechanical testing for MRI compatibility and comparison to a predicate, not a clinical or performance study with detailed acceptance criteria for a medical device's efficacy or accuracy in diagnosis/treatment.

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