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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 Sequel Ring Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The Sequel® External Fixation System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. The Subject device includes additional components (tabbed rings and struts) compared to the primary predicate. The tabbed rings and struts are substantially equivalent to the tabbed rings and struts in the secondary predicates. Special wrenches and accessories are included for the proper assembly of the components. The components of the frame are manufactured from titanium, stainless steel, and aluminum.

The provided FDA 510(k) summary for the Sequel External Fixation Device (K202833) does not describe acceptance criteria for an AI/CADe device or a study demonstrating such criteria.

This document pertains to a medical device (external fixation system), not an AI or CADe product. The information included in the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (materials, operating principle, components)
• Performance Testing (biocompatibility and bench testing in accordance with ASTM F1541-17, sterilization validation in accordance with ISO 17665-1:2006 and ISO/TS 17665-2:2009).

Since this is a filing for a physical medical device and not an AI/CADe system, the requested information regarding AI/CADe acceptance criteria, study details, ground truth, sample sizes for test/training sets, experts, and MRMC studies is not applicable and therefore not present in the provided text.

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