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The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Reliance VBS System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously marketed devices, often through comparison of design, materials, and intended use.

*Crucially, this document does not describe acceptance criteria, performance metrics, or any study results typical of an AI/ML or diagnostic device.

The Reliance VBS System is a spinal implant (a spacer to replace a portion of a vertebral body). Its "performance" is primarily assessed through its design, materials, and mechanical properties, not through a clinical study that would have a "test set," "ground truth," or "expert readers" in the way one might evaluate an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information in the table or the detailed points about studies, sample sizes, and ground truth establishment, as these concepts are not applicable to the information contained in this 510(k) summary for a physical orthopedic implant.

The document states:

• Device Description: The Reliance VBS device is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. It may be made of PEEK with Tantalum markers, or made of Titanium alloy.
• Intended Use/Indications for Use: For use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression, restore height, and biomechanical integrity. It is to be used with a cleared supplemental fixation device and bone graft.
• Substantial Equivalence: The device is stated to be substantially equivalent to several legally marketed predicate devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

To reiterate, this is a hardware device approval, not a software or AI approval. Therefore, the concepts requested in the prompt (acceptance criteria for a study, device performance results, sample sizes for test/training sets, ground truth, expert adjudication, MRMC comparative effectiveness studies, and standalone algorithm performance) are not present in this type of regulatory submission and are not relevant to the approval of this spinal implant.

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The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column

The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). In addition, the Spinal USA VBR System is intended for use with bone graft.

The Spinal USA VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system consists of a straight, curved, round, and trapezoidal implants. The various implants via shallsin, curved, curved, curved, the individual patient anatomy. All components are made from medical grade titanium or titanium or titanium or titanium or titanium or titanium or titanium or titanium or tit alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

This document is a 510(k) summary for the Spinal USA VBR System, a vertebral body replacement device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than a detailed performance study with acceptance criteria in the typical sense of AI/software devices. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not available in the provided 510(k) summary. For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This is typically shown through:

• Materials testing: Ensuring the device materials meet established standards (e.g., biocompatibility, mechanical properties).
• Mechanical testing: Demonstrating that the device performs equivalently or better than predicate devices under specified biomechanical loads.
• Design similarities: Highlighting that the device's design and intended use are similar to predicate devices.

The document states: "Testing in accordance with ASTM F2077-03 'Test Methods for Intervertebral Body Fusion Devices' of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109)."

This statement implies that the device met the performance requirements outlined in ASTM F2077-03, which serves as the "acceptance criteria" for mechanical performance, to establish substantial equivalence. However, the specific quantitative criteria (e.g., "withstanding X N of compression for Y cycles") and the exact performance results are not reported in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of a mechanical device 510(k) submission like this. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes. Data provenance for such mechanical testing typically relates to the lab where tests were conducted, not country of origin of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth in the context of mechanical device testing refers to established engineering specifications, material standards, and biomechanical principles, not expert medical opinion on images or clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biomechanical testing protocols. The device's ability to maintain spinal stability and integrity, as well as its material properties, are objectively measured against these predefined standards. For instance, the ASTM F2077-03 standard specifies methods for evaluating intervertebral body fusion devices, and conformance to this standard serves as a form of "ground truth" for mechanical performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

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