(55 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ASTM F2077-03 "Test Methods for Intervertebral Body Fusion Devices" for mechanical performance relative to predicate devices. | The device "demonstrates that the device is substantially equivalent" to listed predicate devices through testing in accordance with ASTM F2077-03. Specific numerical performance data are not provided in this summary. |
| Materials meeting medical-grade standards (e.g., ASTM F136 or ISO5832-3). | All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. |
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.