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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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CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The CO Vertebral Body Replacements are rectangular shaped in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the spacers is open to provide space for bone graft. The implant is always implanted in the vertical position. These components are available in various heights (7mm-150mm) and cross sections to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The CO components are fabricated from pure poly(ether cther ketone) (PEEK). This material closely matches the modulus of elastical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. I wo metal wires at the opposite cads of the spacers allow radiological confirmation of the cage position post operatively.

This 510(k) summary describes a spinal implant device (CO Vertebral Body Replacements) and therefore does not include information about acceptance criteria or a study proving that the device meets them in the context of device performance metrics like sensitivity, specificity, accuracy, etc., which are typically found for AI/ML-driven devices or diagnostic tools.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. The "study" mentioned is a non-clinical summary that compares the new device to a previously cleared one.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a mechanical device, and the "test set" in this context refers to the non-clinical comparative analysis against a predicate device, not empirical data from a study with patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth, in the sense of expert consensus on medical images or diagnoses, is not relevant for the regulatory clearance of this mechanical spinal implant based on substantial equivalence.

4. Adjudication method for the test set

• Not Applicable. See above.

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

• Not Applicable. This is a mechanical spinal implant, not an AI-driven diagnostic or assistive device.

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

• Not Applicable. This is a mechanical device.

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

• The ground truth for this submission is based on the previously cleared predicate device (Scient'x Ellys VBR, K033109). The "truth" is established by demonstrating that the new device shares fundamental technological characteristics with a device already deemed safe and effective.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, and there is no "training set" in the computational sense.

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

• Not Applicable. See above.

In summary: The provided document is a 510(k) summary for a mechanical spinal implant. The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to an existing, legally marketed predicate device, rather than extensive clinical trials or performance studies with acceptance criteria as would be seen for diagnostic software or AI/ML devices. The "study" mentioned is a non-clinical comparison focusing on design, materials, and intended use.

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