Search Results

The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

• · Stabilization of Fractures & Osteotomy
• · Rear and Mid-foot Foot Arthrodesis
• · Adult and Pediatric (greater than 2 through 21 years of age) Leg Lengthening
• · Correction of Bone Deformity in Upper & Lower Extremities
  The P&C Software is intended to be used as a component of multilateral external fixations listed above.

The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires, and half pins are attached to the bone and to the frame itself.
The components included in the external fixation system are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are nonpyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.
The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The use of software is optional and is utilized with the bridging and additional necessary hardware elements of the frame.

I am sorry, but the provided text content does not contain the necessary information to answer your request about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document is a 510(k) Premarket Notification from the FDA regarding the Orthex External Fixation System, a physical medical device. It describes:

• Device Name: Orthex External Fixation System
• Indications for Use: Stabilization of Fractures & Osteotomy, Rear and Mid-foot Foot Arthrodesis, Adult and Pediatric Leg Lengthening, Correction of Bone Deformity.
• Components: Rings, partial rings, footplates, monolateral rails, hardware, tensioned wires, half pins.
• Materials: Various types of metal and plastic.
• Software Component: "The web based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System." It explicitly states the use of software is optional.
• Performance Data: Biocompatibility assessment, mechanical performance evaluations (self-taping, insertion torque, torsional strength, static and dynamic bending), and Hydroxyapatite (HA) Coating performance and characterization evaluations. These are physical/mechanical tests, not performance metrics for an AI/ML algorithm.

There is no mention of:

• AI/ML algorithms or their performance.
• Acceptance criteria for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Test sets for AI/ML models (sample size, data provenance).
• Ground truth establishment by experts for imaging.
• Multi-reader multi-case (MRMC) studies.
• Standalone algorithm performance.
• Training sets for AI/ML models or their ground truth establishment.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about the AI/ML study.

Ask a specific question about this device