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The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text describes a medical device, the Normandy VBR System, and its substantial equivalence determination by the FDA. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI/algorithm's performance.

The document is a 510(k) premarket notification approval letter and summary for a spinal implant. It focuses on demonstrating that the Normandy VBR System is substantially equivalent to existing predicate devices based on design, intended use, material composition, function, and mechanical performance.

Therefore, I cannot fulfill your request for information regarding AI device acceptance criteria and a study proving an AI device meets them. The provided text does not describe an AI medical device or its performance evaluation in the context you've outlined.

Here's what the document does provide the closest to your request, but is entirely in the context of a physical medical device (spinal implant) and its mechanical testing, not AI:

1. A table of acceptance criteria and the reported device performance:

Important Note: The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices through mechanical testing. The document doesn't provide specific quantitative thresholds for these tests but rather states that the "mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices."

The following points cannot be addressed as the provided text pertains to a physical spinal implant, not an AI/algorithmic device:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

The provided text is a 510(k) premarket notification summary for a medical device called the "Normandy VBR System." This document describes the device's indications for use, its mechanical characteristics, and its substantial equivalence to predicate devices based on mechanical performance testing.

It is crucial to understand that this document does not describe a study involving an artificial intelligence (AI) device or a study involving human readers/interpreters of medical images. Therefore, I cannot provide information on acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as requested in your prompt. These elements are typically associated with studies evaluating diagnostic or prognostic AI algorithms, not with physical implantable medical devices like the Normandy VBR System.

The "Performance Data" section explicitly states: "Mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices. Static and Dynamic Axial Compression, Static and Dynamic Torsion, Subsidence, and Expulsion (per internal protocol) testing was performed in accordance with ASTM F2077 and ASTM F2267."

This refers to physical, biomechanical testing of the device's structural integrity and function, not evaluation of a diagnostic algorithm's accuracy or interpretation by human readers.

Therefore, I must state that the requested information (points 1-9) about acceptance criteria and study proving device performance cannot be extracted from the provided text because the device and the associated testing are not related to an AI/diagnostic imaging context.

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