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The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system.

The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Spinal USA Interbody Fusion Device consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek, LT1). The products are supplied clean and "NON-STERILE".

The provided text does not contain information about acceptance criteria or a study proving the device meets them. Instead, it describes a 510(k) summary for an Intervertebral Body Fusion Device, focusing on its intended use, device description, and substantial equivalence to predicate devices. There is no mention of specific performance metrics, test sets, ground truth establishment, or clinical studies involving AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided document.

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The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolater al surgicul approach above the bifurcation of the great vessel or via the exterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temperary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degreerative discase (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture and dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21mm, 23mm, The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm, 35mm. The plates locking mechanism is a preassembled rivet that is attached to every plate. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

The provided text is a 510(k) summary for the Spinal USA Anterior Lumbar Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The information you are asking for (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) is typically found in data describing the validation of AI/ML algorithms. The document provided outlines the regulatory submission for a physical medical device (an anterior lumbar plate system), for which "performance data" would refer to mechanical testing and biocompatibility rather than AI/ML algorithm performance.

Therefore, I cannot provide the requested information from the given text.

The provided text does not contain the necessary information to answer your questions regarding acceptance criteria and a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

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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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