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The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 – T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

Patients should receive at least six (6) weeks of non-operative treatment with the CarboClear Cervical Cage System.

The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 - T1).

The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).

When used at more than two levels, supplemental fixation should include posterior fixation. The use of allograft or autograft with the CarboClear Cervical VBR device is optional.

1. CarboClear Cervical Cage System is composed of implants of various sizes, and of instruments. The CarboClear Cervical Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

2. The CarboClear Cervical VBR System is composed of implants (spacers) in various sizes, and of instruments. The CarboClear Cervical VBR spacers are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

This appears to be a review of a 510(k) premarket notification for two spinal implant systems: the CarboClear® Cervical Cage System and the CarboClear® Cervical VBR System. This document does not describe a study that uses a test set, experts, or ground truth to evaluate device performance against acceptance criteria in the manner you are asking about for AI/software devices.

Instead, this is a regulatory document addressing the substantial equivalence of medical devices, primarily based on engineering and material performance testing rather than clinical efficacy studies in the AI/ML context.

Therefore, I cannot provide the requested information for acceptance criteria and the study proving the device meets them because the provided text does not contain that type of study.

Here's why and what kind of information is present:

• Type of Device: These are physical medical implants (cages and vertebral body replacement systems for the cervical spine), not AI/software.
• Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device already on the market, meaning it's as safe and effective as the existing device. It does not typically require new clinical effectiveness trials in the way a PMA (Pre-Market Approval) or studies for novel AI algorithms might.
• Performance Data: The document mentions "Performance Data" which refers to benchtop mechanical testing according to ASTM (American Society for Testing and Materials) standards. This is to ensure the implant's structural integrity, durability, and resistance to wear are comparable to predicate devices.

Specifically, the document mentions these performance tests:

• Static and dynamic axial compression tests (according to ASTM F2077)
• Static and dynamic compression-shear tests (according to ASTM F2077)
• Static and dynamic torsion tests (according to ASTM F2077)
• Wear debris evaluation
• Subsidence test (according to ASTM F2267)

It states: "as applicable to each of the devices, are comparable to those of predicate devices (where applicable), thus demonstrating that the devices are safe and effective for their intended use."

My answers to your specific points, based on the provided text, will reflect this distinction:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly present a table of acceptance criteria with specific numerical targets and the device's performance against them. It broadly states that the performance characteristics are comparable to those of predicate devices. The specific benchmark values would be detailed in the confidential 510(k) submission, not typically in the public summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The provenance is from benchtop testing, not clinical data, and the sample size for mechanical tests would typically refer to the number of implants tested, which is not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device does not use an "expert ground truth" in the AI/ML sense. Mechanical tests are performed by engineers and technicians according to standardized protocols.

4. Adjudication method for the test set: Not applicable. This refers to consensus building among experts for labeling data, which is not relevant for mechanical 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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For mechanical testing, the "ground truth" is adherence to the specified ASTM standards and comparable performance to predicate devices demonstrated through physical measurements. This is not "expert consensus, pathology, or outcomes data."

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document is a regulatory approval letter for physical medical implants based on engineering and material performance testing, not an AI/ML device study. Therefore, most of your questions, which are framed for AI/ML device evaluation, are not applicable here.

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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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