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The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.

Patients should have at least six months of non-operative treatment prior to surgery.

CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments.

The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.

The provided text is a 510(k) summary for the CarboClear® Lumbar Cage System, a medical device for intervertebral body fusion. It describes the product, its intended use, and claims substantial equivalence to predicate devices, but it does NOT contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study for an AI/ML device would.

Therefore, I cannot provide the requested table or specific points related to acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) process for this type of device (an intervertebral body fusion device) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than novel clinical performance studies with acceptance criteria in the sense typically applied to diagnostic AI.

Here's what I can extract based on the provided information, but it won't fulfill all your requested points:

1. Table of acceptance criteria and the reported device performance:

Explanation of Limitations:

• No explicit "acceptance criteria" for clinical performance: This document is a 510(k) summary for a physical implant, not an AI/ML diagnostic. The "acceptance criteria" here are geared towards demonstrating safety and effectiveness based on equivalence to existing devices, primarily through mechanical testing and comparison of features, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI clearances.
• No "study" in the sense of AI/ML clinical validation: The "study" mentioned is primarily focused on mechanical performance (finite element analysis, ASTM F2077 testing, expulsion test) to ensure the device is physically robust and performs similarly to predicate devices. There is no mention of a human-in-the-loop study, a standalone algorithm performance study, or a study involving human readers or expert radiologists to establish ground truth for clinical diagnostic performance.

Regarding your specific points where information is not available in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" here refers to mechanical testing, not a clinical data set for performance evaluation in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical performance, the ground truth would be the established engineering standards (e.g., ASTM F2077) and physical measurements. For the overall device, the ground truth for safety and effectiveness is established by comparison to legally marketed predicate devices that have a history of safe and effective use.
8. The sample size for the training set: Not applicable (not an AI/ML device).
9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).

In summary, the provided document details the regulatory clearance of a physical medical implant based on substantial equivalence to predicate devices, supported by mechanical testing. It does not provide the type of performance evaluation details typically associated with AI/ML diagnostic software.

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The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.

Patients should have at least six months of non-operative treatment prior to surgery.

CarboClear® Lumbar Cage System is composed of implants of various sizes, and instruments.

The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.

Unfortunately, the provided text does not contain the specific information required to answer your request about acceptance criteria for an AI/ML powered medical device and the study that proves it meets those criteria.

The document is a 510(k) summary for the "CarboClear® Lumbar Cage System," which is an intervertebral body fusion device made of carbon fiber-reinforced PEEK and titanium alloy. This is a physical implant, not an AI/ML powered device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Details about sample size, data provenance, expert qualifications for test set ground truth, or adjudication methods for an AI/ML study.
3. Information on MRMC studies or effect sizes of AI assistance.
4. Details on standalone algorithm performance.
5. Type of ground truth used for AI/ML.
6. Sample size and ground truth establishment for an AI/ML training set.

The document does mention performance data for the CarboClear® Lumbar Cage System, which includes mechanical tests like static and dynamic axial compression, compression-shear, wear evaluation, subsidence, expulsion, and endplate shear tests. These are standard tests for spinal implants, demonstrating the physical device's mechanical integrity and similarity to predicate devices. However, this is not related to AI/ML performance.

Ask a specific question about this device