(59 days)
The Paragon 28 External Ring 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 Paragon 28 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 Paragon 28 External Ring 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 Paragon 28 External Ring 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 Paragon 28 External Ring 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.
This document is a 510(k) Summary for the Paragon 28 External Ring Fixation System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study or for evaluating AI performance. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.
The document focuses on:
- Indications for Use: Listing the medical conditions the device is intended to treat.
- Device Description: Describing the components and modular nature of the system.
- Predicate Devices: Identifying legally marketed devices to which the Paragon 28 system claims substantial equivalence.
- Performance Testing Summary: Stating that non-clinical testing was performed according to ASTM F1541, which is a standard for external fixation devices. This is mechanical performance testing, not clinical performance for diagnostic accuracy or effectiveness with human intervention.
- Comparison of Technological Characteristics: Arguing that the subject device shares material, design, and operating principles with the predicate devices.
- Conclusion: Stating that the device is substantially equivalent based on the provided information.
In summary, the provided FDA 510(k) clearance letter and summary are for a traditional medical device (an external ring fixation system) and do not contain information related to AI or a study designed to evaluate its clinical performance against specific acceptance criteria as you've outlined.
§ 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.