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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.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided FDA 510(k) summary for the Paragon 28 APEX 3D Total Ankle Replacement System does not contain information related to AI/ML device performance or clinical studies using AI/ML. The document describes a traditional medical device (an ankle replacement system) and focuses on its mechanical performance testing and substantial equivalence to predicate devices based on physical properties, materials, and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are specific to the evaluation of AI/ML-driven medical devices, not the type of device described in this document.

The document details:

• Device Type: Total Ankle Replacement System (mechanical implant).
• Performance Testing: Focuses on mechanical characteristics like range of motion, contact stress, fatigue strength, polyethylene wear, etc.
• Substantial Equivalence: Based on intended use, indications, design, materials, and size range compared to predicate mechanical devices.

Thus, all specific questions regarding AI/ML device evaluation (e.g., test set, ground truth, experts, MRMC, standalone performance, training set) are not applicable to the content provided.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

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