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The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.

The provided document is a 510(k) premarket notification for a medical device called the "Additive Orthopaedics Bunion System." This document does not describe a study involving an AI/Machine Learning device and human readers, nor does it provide acceptance criteria and performance metrics in the way requested for such studies.

This document describes a traditional medical device (metallic bone fixation appliances) and focuses on demonstrating substantial equivalence to pre-existing predicate devices through mechanical testing and comparison of technological characteristics.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC studies, or training sets, as these are not relevant to the content of this 510(k) submission.

Key takeaway from the document:

• Device: Additive Orthopaedics Bunion System (plate and screws for bone fixation).
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices for the indication of alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis of small bones (foot and ankle).
• Methods of demonstration: Comparison of technological characteristics (indications, dimensions, geometry, materials, manufacturing process) and mechanical testing (4-point bending per ASTM F382, static driving torque, removal torque, static axial pullout per F543).
• Conclusion: The device is substantially equivalent to the predicate devices and is expected to perform at least as well.

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The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

The Additive Orthopaedics Lattice Locking Plates consist of a plate and locking and non-locking screws with surgical site preparation and insertion instruments. It is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The locking lattice plate and screws come in multiple sizes.

The provided text is a 510(k) premarket notification for a medical device (Additive Orthopaedics Locking Lattice Plate). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical evidence. However, this document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/algorithm-based diagnostic or assistive device.

The document describes a mechanical device, specifically a surgical plate, and the assessment of its physical properties for substantial equivalence to existing similar devices. It does not involve any AI algorithms, human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity, specificity, or AUC, which are typically found in studies for AI-powered medical devices.

Therefore, I cannot provide the requested information based on the provided text, as the context is entirely different.

Here's why and what the document does discuss regarding evaluation:

• Device Type: The "Additive Orthopaedics Locking Lattice Plate" is a physical implant used for bone fixation.
• Evaluation Method: The document relies on "Substantial Equivalence - Non-Clinical Evidence" which includes mechanical testing (e.g., 4-point bending, static torsion, static axial pullout) per ASTM standards (F382, F543) and bacterial endotoxin testing (LAL pyrogen testing).
• "Acceptance Criteria" in this context: The "acceptance criteria" are implied by meeting the performance demonstrated by the predicate devices through the specified ASTM standards and pyrogen limits (e.g., "Pyrogen levels for the device system were below the 20 EU/device limit"). The study demonstrating this is the mechanical and biological testing itself.
• No AI/Algorithm: The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," or "standalone algorithm performance" are not applicable because this is not an AI-driven device.

To reiterate, the requested information cannot be extracted from the provided text because it pertains to an entirely different type of medical device evaluation (mechanical implant vs. AI/diagnostic software).

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