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The Succession™ Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

• Failed ankle replacement
• Arthritis of ankle and subtalar joint
• Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
• Revision of failed ankle and/or subtalar fusion
• Revision of failed Tibiotalocalcaneal (TTC) fusion
• Talar Avascular Necrosis (AVN)
• Charcot
• Trauma
• Neuroarthropathy
• Pseudoarthrosis
• Rheumatoid arthritis

The Succession™ AFN System is comprised of a set of straight 10mm, 11mm, and 12 mm diameter cannulated nails, 12.5mm diameter end caps, 5mm and 6mm diameter cortical screws, and accessory instrumentation. All implants are composed of Titanium (Ti-6Al-4V ELI) and provided to the user sterile packed with a combination of both sterile and non-sterile accessory instrumentation to assist in implantation. Each of the accessory instruments provided with the subject device contain substantially equivalent materials to the Oxford™ Ankle Fusion Nail System predicate device instrumentation, including stainless steel (ASTM F899 and ASTM F138 / ISO 5832-1) and Fluorinated Ethylene Propylene direct contacting materials.

During the procedure, following preparation of the tibial intramedullary canal (using the device accessory instrumentation) and placement of the intramedullary fixation nail, the provided 5mm screws are inserted into the medial to lateral (M/L) slots of the implant, allowing for fixation in the tibia, talus, and calcaneus. In both the talus and calcaneus, dynamic compression slots are included in the nail and are to be used with the internal and/or external methods of compression across the tibiotalar and subtalar joints. In addition, a 6mm screw is placed through the only angled posterior to anterior (P/A) slot located at the distal end of the nail implant, allowing for additional fixation between the calcaneus and talus. Following the placement of all screws, the end caps are implanted to add stability to the distal end of the nail and prevent excess bony ingrowth from occurring within the nail cannulation. Overall, the Succession™ Ankle Fusion Nail is intended to effectively fuse the tibiotalar and subtalar joints together, providing stability in the hindfoot region to facilitate tibiotalocalcaneal arthrodesis.

Based on the provided FDA 510(k) Clearance Letter, the Succession™ AFN System is an intramedullary fixation rod, and the clearance is primarily based on substantial equivalence to predicate devices. This means the device is demonstrated to be as safe and effective as a legally marketed device, not necessarily by proving it meets specific quantitative performance acceptance criteria for an AI/machine learning device.

The document provided does not contain information about an AI/ML-driven device's acceptance criteria or a study proving its performance. The "Non-Clinical and/or Clinical Tests Summary" in the document describes mechanical testing of the physical device (nails, screws, and accessories) for properties like torsional yield strength, driving torque, pullout strength, self-tapping force, cyclic fatigue, bending strength, torsional strength, and corrosion resistance.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The provided text is solely about the substantial equivalence of a physical orthopedic implant.

If this were a document about an AI/ML device, the sections you requested would typically be found in a "Performance Benchmarking" or "Clinical Study" section, detailing the AI's accuracy, sensitivity, specificity, or impact on human performance, along with the study methodology.

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The Ortho Solutions COGNITiON™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON™ Staple System is not intended for spinal use.

The COGNITION Staple System is comprised of a set of implantable metallic (Superelastic NiTi Alloy per ASTM F2063) staples and accessory instrumentation. The system consists of a series of two and four-leg staples of various bridge and leg lengths. Each staple is provided to the user in a relaxed state with the staple legs in a converging position. During the staple insertion step, the provided staple driver is used to splay the staple legs, allowing for implantation across the fracture, fusion, or osteotomy site. The staple legs then have the inherent propensity to converge due to the superelastic nature of the NiTi material. This stability is intended to allow for bone healing to occur.

This document is a 510(k) premarket notification for the COGNITION™ Staple System, a medical device for bone fixation. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information related to an AI/ML-driven device or an AI performance study. The document describes a traditional medical device (a staple system) and its mechanical and non-clinical testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets the acceptance criteria in the context of an AI/ML system, as this information is not present in the provided text.

The document discusses:

• Device Name: COGNITION™ Staple System
• Intended Use: Hand and foot bone fragments, osteotomy, fixation, and joint arthrodesis. Not for spinal use.
• Device Description: Comprised of implantable metallic (Superelastic NiTi Alloy) staples and accessory instrumentation.
• Predicate Device: K111678 Ortho Solutions Extremity Fixation Implants for Osteosynthesis.
• Technological Comparison: The new device is stated to have the same materials, chemical composition, manufacturing methods, austenite finish temperature, similar size range, and sterilization methods as the predicate.
• Non-Clinical Tests: Mechanical testing per ASTM F564 Annex A1 and A4, and corrosion testing per ASTM F2129-19a.
• Conclusions: The COGNITION device was found to be superior in static bending strength, constant amplitude bending resistance, and corrosion resistance compared to the predicate.

The document does not contain any details about:

• AI/ML algorithms
• Test sets, training sets, or data provenance for AI models
• Expert involvement for establishing ground truth in an AI context
• Adjudication methods for AI performance
• MRMC comparative effectiveness studies (AI vs. human)
• Standalone AI algorithm performance
• Types of ground truth for AI
• Sample sizes for training or test sets in an AI context
• Ground truth establishment for training sets in an AI context

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