Search Results

The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.

The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.

The provided text does not contain information about acceptance criteria for a medical device's performance, nor does it detail a study proving such criteria are met in the context of AI/ML or diagnostic image analysis. Instead, the document is a 510(k) summary for the "Austin Miller External Fixation System," a surgical device used for stabilizing bones.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Bone stabilization for adult and pediatric patients with long bone, feet, and pelvic fractures, non-unions, periarticular fractures, infected fractures/non-unions, joint-bridging immobilization, arthrodeses, and osteotomies.
• Device Description: Consists of stainless steel bone pins, composite bars, and titanium clamps.
• Technological Characteristics: Similar materials, size, strength, stiffness, assembly, and adjustment methods compared to predicate devices.
• Performance Data (Mechanical and MRI Safety):
  • Mechanical Testing: Pin pullout and strength testing (following ASTM F1541), grip testing of clamps, and construct testing to failure. These tests aimed to show equivalence or superiority to predicate devices in terms of load-bearing capacity.
  • MRI Safety Testing: Force and torque testing in magnetic fields, image distortion testing, radiofrequency induced heating simulation, and radiofrequency induced heating testing. This was done to determine safe conditions for MRI scanning with the device implanted.

Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML-based device or a study with acceptance criteria, ground truth, expert review, or sample sizes in the context of diagnostic performance.

Ask a specific question about this device