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Cervical

KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) 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. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants 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.

Thoracolumbar

KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.

These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants 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 thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation.

Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

This document is a 510(k) summary for the KONG®-TL VBR System and KONG®-C VBR System, which are vertebral body replacement systems. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present "acceptance criteria" in a typical quantitative sense (e.g., target accuracy, sensitivity/specificity values). Instead, the performance testing aims to demonstrate substantial equivalence to legally marketed predicate devices by conforming to established ASTM standards for various mechanical properties. The "reported device performance" are the results from these tests, which were deemed sufficient to show equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical mechanical performance testing. This typically involves physical samples of the medical device or its components.

• Sample Size: Not explicitly stated in terms of a numerical count of tested devices. It refers to "worst-case construct" for expulsion testing, implying selection based on anticipated highest stress. For other tests, it's implied that a statistically relevant number of samples were tested to meet ASTM standard requirements, but the exact number is not provided in this summary.
• Data Provenance: The tests are non-clinical (benchtop, laboratory testing) performed by "the company" (icotec ag). Since it's mechanical testing of the device itself, there is no patient data or "country of origin of the data" in the sense of clinical study demographics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This question is not applicable. The study is a non-clinical mechanical performance test, not a clinical study involving diagnosis or interpretation by experts. The "ground truth" here is compliance with engineering standards and mechanical integrity, not medical findings.

4. Adjudication Method for the Test Set:

This question is not applicable. There is no expert adjudication needed for non-clinical mechanical testing. The results are typically objectively measured and compared against standard specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical mechanical performance testing to demonstrate substantial equivalence to predicate devices, not on a clinical comparison involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this question is not applicable. The device (KONG®-TL VBR System and KONG®-C VBR System) is a physical medical implant, not an AI algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for this non-clinical performance evaluation is based on established engineering standards (ASTM F2077, ASTM F2267) and the mechanical properties and performance of legally marketed predicate devices. The testing aims to show that the subject device performs similarly or meets the safety and effectiveness requirements defined by these standards, thereby demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. Since the device is a physical implant and the study is non-clinical mechanical testing, there is no "training set" in the context of an algorithm or statistical model.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no "training set" for this type of device and study.

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The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 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 thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them in the format you requested.

Specifically, the document is an FDA 510(k) clearance letter and summary for a pedicle screw system. While it mentions "performance testing summary" and "engineering rationales for mechanical testing, biocompatibility assessment, and clinical evidence" to demonstrate substantial equivalence, it does not provide the specific acceptance criteria, reported device performance metrics against those criteria, details of a study (like sample size, data provenance, ground truth establishment, or expert involvement), or any information about AI assistance or standalone algorithm performance.

Therefore, I cannot fulfill your request for items 1 through 9.

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The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-TI) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone.

This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

The icotec Cervical Cage is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a Ti-iT® rough CP-titanium coating. The devices are intended to be used with supplemental spinal fixation. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.

This document is a 510(k) summary for the icotec Cervical Cage, which is a medical device. The document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared devices.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format typical of an AI algorithm's performance. Instead, it focuses on demonstrating that the icotec Cervical Cage (subject device) is substantially equivalent to predicate devices. The performance criteria for "substantial equivalence" are based on a comparison of indications for use, design, materials, function, and manufacturing.

The performance testing summarized relates to mechanical properties, not clinical outcomes directly measured against specific numeric criteria for the device itself.

2. Sample Size Used for the Test Set and Data Provenance:

• Mechanical Testing: Not specified in terms of "sample size" for a test set in the way one would for a clinical study. These are benchtop tests. The standards (ASTM, ISO) typically define the number of samples required for each test. The document does not provide the specific number of units tested.
• Clinical Literature Review: No specific "test set" was used for the subject device. Instead, a "comprehensive clinical literature review" was conducted on representative cervical cages. The data provenance would be from the published literature, which could include retrospective and prospective studies from various countries. The document does not specify the origin or type of studies included in this review.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this document. The FDA 510(k) clearance process for this medical device (intervertebral body fusion device) relies primarily on demonstrating substantial equivalence through mechanical testing and a review of existing clinical literature for similar devices. There is no mention of human experts establishing a "ground truth" for a test set in the context of an AI device or diagnostic tool.

4. Adjudication Method for the Test Set:

This information is not applicable. Since there is no human-interpreted "test set" in the context of an AI algorithm or diagnostic tool described here, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (an implantable cage), not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of human readers improving with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used:

• For Mechanical Testing: The "ground truth" is established by the specifications and tolerances defined by the relevant ASTM and ISO standards for properties like compression, shear, torsion, expulsion, wear, and coating characteristics.
• For Expanded Clinical Indications (multi-level use): The "ground truth" (or supporting evidence) for the clinical performance aspect was based on a "comprehensive clinical literature review" of existing data from representative cervical cages. This relies on published outcomes data from those prior studies.

8. The Sample Size for the Training Set:

This information is not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable. As there is no training set mentioned.

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The VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The VADER® one Pedicle System MIS is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.

The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.

This document is a 510(k) summary for the VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, which are spinal implant devices. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/ML device.

The provided text focuses on the regulatory clearance process for a medical device (pedicle screw system), which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through material, design, function, and performance testing (e.g., mechanical tests like ASTM F543, F1717, F1798, and biocompatibility).

Here's why the requested information cannot be extracted from this document:

• No mention of AI/ML: The document describes a physical medical device (pedicle screw system) and its mechanical and biocompatibility testing. There is no indication that this device is an AI/ML diagnostic or therapeutic tool with performance metrics like sensitivity, specificity, or accuracy.
• Performance testing is for mechanical equivalence, not diagnostic accuracy: The "Performance Testing Summary" lists standards like ASTM F543 (screw testing) and ASTM F1717 (pedicle screw system testing). These are industry standards for evaluating the mechanical properties and structural integrity of spinal implants. They are not metrics for evaluating the performance of a diagnostic or predictive algorithm.
• "Clinical Data" is mentioned but not detailed: While "Clinical Data" is listed as one of the performance tests, no details are provided about what this data entails, how it was collected, what endpoints were measured, or if it relates to a study proving performance against acceptance criteria for an AI/ML system. In the context of a pedicle screw system, clinical data would typically refer to observational studies or clinical trials assessing patient outcomes, fusion rates, complication rates, etc., which are different from a study proving algorithm performance.
• No acceptance criteria for AI/ML performance: Given the nature of the device, there are no acceptance criteria defined for metrics such as sensitivity, specificity, AUC, or accuracy, which would be relevant for an AI/ML device's performance.

Therefore, since the device described is a physical medical implant and not an AI/ML-driven diagnostic/therapeutic tool, the questions about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, and standalone performance for an AI/ML device are not applicable to this document.

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