(28 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.