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The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X CORE® Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The NuVasive X-CORE® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following Corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-CORE® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive X-CORE® Mini Cervical Expandable 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

X-Core Expandable VBR and X-Core Mini Cervical Expandable VBR devices are vertebral body replacement devices manufactured from Titanium alloy Ti6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. Devices are offered in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The purpose of this 510(k) application is to add the sterile implants option to the previously cleared system.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA clearance letter for a medical device (NuVasive X-Core® Expandable VBR System), outlining its indications for use, technological characteristics, and stating its substantial equivalence to predicate devices. It mentions performance data related to sterilization and packaging but does not include details on acceptance criteria or clinical/comparative studies involving device performance metrics as requested in your prompt.

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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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When used as an Intervertebral Body Fusion Device:

The Virtu C cervical spine devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Virtu C device is intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Virtu C device is intended to be used with a FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

When used as a Vertebral Body Replacement Device:

The Virtu C device is indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed or unstable vertebral body due to trauma/fracture or tumor to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Virtu C device is intended to be used with autograft and/or allograft bone. The Virtu C device is intended to be used with a FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met 1 Technologies Virtu C Spinal Intervertebral Body Fusion Device is a cervical intervertebral body fusion device that is implanted into the invertebral body space to improve stability of the spine while supporting fusion. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The Met 1 Technologies Virtu C Spinal Vertebral Body Replacement Device is a thoracolumbar vertebral body replacement device that is implanted to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. A variety of implant sizes are provided to accommodate individual patient anatomy. The implants are manufactured from VESTAKEEP® i4 R PEEK per ASTM F2026 and have tantalum markers per ASTM F560.

The provided document is a 510(k) summary for the Virtu C Spinal Implant, a medical device for spinal fusion and vertebral body replacement. This document primarily focuses on demonstrating substantial equivalence to predicate devices, and therefore does not contain information about a study proving device performance against acceptance criteria in the typical sense of a clinical or image-based AI study with metrics like sensitivity, specificity, or AUC.

Instead, the "performance data" referred to in this document relates to mechanical testing of the implant. The acceptance criteria are implicit in the fact that the device "demonstrated substantial equivalence" to predicate devices through these mechanical tests.

Here's an breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for the mechanical tests, but typically involves a set number of physical implant samples per test. This is not a "test set" in the context of clinical AI/imaging data.
• Data Provenance: Not applicable. These are mechanical laboratory tests of physical devices, not data derived from patients or real-world usage.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not through expert clinical consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are quantitative and objective, typically not requiring subjective adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, this document does not describe an MRMC study. This type of study is relevant for diagnostic imaging devices or AI algorithms that assist human readers, not for purely mechanical implants.
• Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No, this document does not describe a standalone performance study. This term is typically used for AI algorithms. The "performance data" here refers to the mechanical performance of the physical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical tests, the "ground truth" (or reference standard) is the established performance characteristics and safety profiles of the identified predicate devices, as well as the specifications and limits defined by the relevant ASTM test standards (e.g., F2077, F2267). The device being tested must perform equivalently to these standards and predicates.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI or machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a series of mechanical performance tests conducted on the Virtu C Spinal Implant System. These tests are:

• Static axial compression per ASTM F2077
• Static torsion per ASTM F2077
• Static subsidence per ASTM F2267
• Static expulsion per ASTM F-04.25.02.02
• Dynamic axial compression per ASTM F2077
• Dynamic torsion per ASTM F2077

The document states that the device was tested in these modes and "demonstrated substantial equivalence" to the predicate devices. This implies that the results of these tests fell within acceptable limits defined by the ASTM standards and were comparable to the known performance of the predicate devices. The acceptance criteria are, therefore, implicitly tied to meeting the performance characteristics of the legally marketed predicate devices and adhering to the specifications of the referenced ASTM standards. No specific raw data or quantitative results from these tests are provided in this 510(k) summary, only the conclusion that substantial equivalence was demonstrated.

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