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The Small Bone Phantom® Intramedullary Nail System is indication and fixation and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, pseudarthroses and malunions by revision. joint fusion or reconstruction procedures.

The TTC Phantom® Intramedullary Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• · Revision of failed ankle arthrodesis
• · Revision of failed total ankle arthroplasty
• · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• · Osteoarthritis
• · Nonunions or pseudarthrosis of hindfoot and distal tibia
• · Trauma (severe or malunited tibial pilon fracture)
• · Charcot foot (neuroarthropathy)
• · Severe end-stage degenerative arthritis
• · Instability and skeletal defects after tumor resection
• Pantalar arthrodesis
• · Severe foot/ankle deformity

The Paragon 28® Small Bone Phantom® Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Small Bone Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Small Bone Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

The Paragon 28® TTC Phantom® Intramedullary Nail System is comprised of intramedullary nails, screws and accessory components. The TTC Phantom® nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The TTC Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required

This document is a 510(k) Premarket Notification from the FDA regarding the "Small Bone Phantom® Intramedullary Nail System" and the "TTC Phantom® Intramedullary Nail System." It is a regulatory clearance document rather than a study report proving a device meets acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning the performance of an AI/algorithm-based medical device.

The document focuses on:

• Regulatory Clearance: Granting substantial equivalence to predicate devices for the two specified intramedullary nail systems.
• Indications for Use: Detailing the medical conditions for which these bone fixation devices are intended.
• Device Description and Materials: Information about the physical characteristics and materials of the implants.
• Comparison to Predicate Devices: Demonstrating that the new devices have similar indications, technological characteristics, and function to previously cleared devices.
• "Performance Data" (for these mechanical devices): Mentions "Engineering analysis" and "four-point bend testing per ASTM F1264" for the TTC Phantom, and states that "Clinical data are not needed to support the safety and effectiveness of the subject devices." This refers to mechanical performance testing of a physical implant, not an AI algorithm.

In summary, this document is not applicable to the request about acceptance criteria and a study for an AI device.

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