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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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