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The HV Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• · Mono or Bi-Cortical osteotomies in the foot or hand
• · Distal or Proximal metatarsal or metacarpal osteotomies
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• Akin type osteotomy
• · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
• · Talar/navicular arthrodesis

The HV Screws are cannulated screws offered in 3.0mm diameter, various lengths, and have self-tapping features on both distal and proximal threads. All screws are manufactured from titanium alloy.

The provided document is a 510(k) Premarket Notification from the FDA regarding the HV Screw System by Wright Medical Technology, Inc. This document is a regulatory approval for a medical device (a bone fixation fastener), not a clinical study on an AI/machine learning diagnostic device.

Therefore, the input does not contain the information required to answer the questions about acceptance criteria, study design, ground truth establishment, or human reader performance for an AI/ML device.

Here's why the provided text does not contain the requested information:

• Type of Device: The HV Screw System is a physical medical implant (a screw for bone fixation), not an AI/machine learning software or diagnostic device. As such, the performance criteria and study methodologies described are for a mechanical implant, not an AI algorithm.
• Performance Metrics: The "Validation and/or Verification Method" in the document focuses on mechanical properties like torsional testing, axial pullout force, and bending strength, which are relevant to a screw's physical performance, not diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Clinical Evidence: The document explicitly states "8. Substantial Equivalence- Clinical Evidence: N/A". This indicates that no human clinical study was conducted for this submission, as is often the case for medical devices that demonstrate substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing.
• AI/ML Specifics: There is no mention of algorithms, machine learning, human readers, experts establishing ground truth for diagnostic images, test sets, training sets, or adjudication methods, as these concepts are not applicable to the HV Screw System.

Based on the provided text, I cannot fill in the requested table or answer the specific questions related to an AI/machine learning device.

The document describes the regulatory process for a physical medical device (HV Screw System) and its substantial equivalence to a predicate device based primarily on non-clinical (mechanical) testing. It does not provide any details about an AI/ML study.

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