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The Monkey Rings™ External Fixation System is intended to be used in adults and pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

The Monkey Rings External Ring Fixation System is intended to treat the following patient indications in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g., orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Monkey Rings External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Monkey Rings External Ring Fixation System is a modular, ring-based external fixation system intended for the treatment and fixation of a variety of orthopedic conditions in pediatric and adult patients. The system is designed to stabilize bone segments during fracture management, deformity correction, or limb lengthening procedures. It consists of multiple components, including rings, connecting rods, struts, bolts, fasteners, clamps, plates, pins, and Kirschner wires (K-wires), which can be assembled in various configurations to provide either static fixation or gradual adjustment of bone position. The modular design allows surgeons to tailor the construct to meet specific anatomical and clinical needs.

The subject components included in this submission are the Universal Joint Struts and updated sterilization parameters for the system. The Universal Joint Strut is a newly introduced component designed to allow precise modification of strut length and controlled repositioning of the fixation rings over time. Its universal joint mechanism provides enhanced angular flexibility, enabling improved intraoperative adjustability and postoperative frame modification while maintaining structural stability and fixation integrity. All other components of the Monkey Rings External Ring Fixation System, including rings, connecting rods, and associated fixation hardware, were previously cleared and remain unchanged in design and function.

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The Monkey Rings™ External Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:

• · Open and closed fractures
• · Post-traumatic joint contracture which has resulted in loss of range of motion
• · Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• · Pseudoarthrosis, infected union, non-union, or malunion of long bones
• · Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• · Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• · Correction of segmental bony or soft tissue defects
• · Joint arthrodesis
• · Management of comminuted intra-articular fractures
• · Bone transport

The Monkey Rings™ External Fixation System is indicated in adults for:

• · Osteotomy
• · Revision procedure where other treatments or devices have been unsuccessful
• · Bone reconstruction procedures
• · Fusions and replantations of the foot
• · Charcot foot reconstruction
• · Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• · Lisfranc dislocations
• · Ankle distraction (arthrodiastasis)
• · Septic fusion

The Monkey Rings™ External Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Monkey Rings™ External Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.

Components of the Monkey Rings™ External Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.

The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.

The provided text describes a 510(k) premarket notification for the "Monkey Rings™ External Fixation System" and asserts its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that specifically proves the device meets those criteria, especially in the context of an AI/ML device.

The document outlines the device's indications for use, its description, and references non-clinical performance testing. This testing focuses on engineering analysis for bending strength, biocompatibility, and sterilization, which are standard for mechanical medical devices. It explicitly states, "An engineering analysis of bending strength was conducted to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices."

Since this device is an external fixation system (a mechanical device) and not explicitly an AI/ML device, the questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data are not applicable to the information provided in this document.

Therefore, I cannot provide the requested information because the document does not discuss acceptance criteria or studies related to AI/ML device performance.

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