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The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.

The provided document is a 510(k) premarket notification letter and summary for the LEGEND Spine CORNICE Cervical Spacer System. This document describes a medical device, which is a physical implant, not an AI/ML powered device. As such, it does not include information typically sought for AI/ML devices regarding acceptance criteria, performance studies involving AI, human experts, and ground truth establishment in the way an AI/ML product would.

The performance testing described is mechanical testing for the physical implant to ensure its structural integrity and safety. Therefore, I cannot extract the information required for an AI/ML device from this document.

For completeness, I can describe the type of acceptance criteria and performance testing that were included for this physical device:

Acceptance Criteria and Reported Device Performance (Physical Device - Mechanical Testing)

Missing Information (as this is not an AI/ML device):

• Sample size used for the test set (no test set in the AI/ML sense)
• Data provenance (not applicable for mechanical testing)
• Number of experts used to establish ground truth (not applicable)
• Qualifications of those experts (not applicable)
• Adjudication method (not applicable)
• Multi-reader multi-case (MRMC) comparative effectiveness study (not applicable)
• Effect size (not applicable)
• Standalone performance (not applicable)
• Type of ground truth (not applicable)
• Sample size for the training set (not applicable)
• How ground truth for the training set was established (not applicable)

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is standard for intervertebral body fusion devices. It does not involve any AI/ML components where ground truth and human-in-the-loop performance would be relevant.

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The LEGEND Spine STYLO Interbody Fusion Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.

LEGEND Spine STYLO Interbody Fusion Device implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Legend Spine Technologies STYLO Interbody Fusion Device is an Interbody Fusion Device that has a hollow chamber to permit packing with autologous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine Technologies STYLO interbody implants are made from either PEEK radiolucent material with embedded tantalum x-ray markers (ASTM F2026 and ASTM F560) or titanium alloy conforming to ASTM F136.

The provided text describes a 510(k) premarket notification for the STYLO Interbody Fusion Device. It focuses on demonstrating substantial equivalence to predicate devices through performance testing and does not describe a study involving an AI/CADe/CADx device or clinical performance criteria related to diagnostic accuracy.

Therefore, many of the requested categories for AI/CADe/CADx studies are not applicable to this document. The information available pertains to the mechanical and material performance of a physical implant device.

Here's the information that can be extracted relevant to the "acceptance criteria" and "study" described, interpreted within the context of a medical implant device's 510(k) submission:

Acceptance Criteria and Device Performance (for the STYLO Interbody Fusion Device - an implant)

As this document describes an implantable medical device (STYLO Interbody Fusion Device) and not an AI/CADe/CADx algorithm, the following points are not applicable and cannot be found in the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to mechanical testing of physical device samples, not a dataset of patient cases for algorithm evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant device's mechanical testing is based on engineering specifications and physical measurements, not expert clinical interpretation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance testing consists of predefined mechanical performance standards (e.g., load limits, displacement tolerances) established by ASTM standards and FDA guidance.
7. The sample size for the training set: Not applicable. There is no AI model to be trained.
8. How the ground truth for the training set was established: Not applicable.

Summary of what's provided related to the study:

The study involved Performance Testing of the STYLO Interbody Fusion Device.

• Type of Study: Mechanical and material performance testing.
• Standards Used:
  • ASTM F2077-14 (Standard Test Methods for Intervertebral Body Fusion Devices)
  • ASTM F2267-04 (Standard Test Method for Determining the Rate of Frictional Wear of Intervertebral Body Fusion Devices) - Note: The document lists F2267-04, but F2077-14 is more directly relevant to expulsion and subsidence.
  • Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (June 12, 2007)
• Conclusion: The device meets or exceeds the performance of predicate devices, demonstrating substantial equivalence.

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