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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 graff used at the surgeon's discretion.

When used with the VADER® Pedicle System, the KONG®-TL VBR System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

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.

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.

When used with the icotec Anterior Cervical Plate System, the KONG®-C VBR System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

KONG®-TL VBR System: The KONG®-TL VBR System is a vertebral body replacement system for anterior stabilization of the thoracic and lumbar spine. This device serves as a replacement for vertebral bodies in tumorous and traumatic diseases which lead to instabilities in the anterior support or compression of neural structures or diseases that make an infection repair necessary. The KONG®-TL VBR System is intended for use with an additional dorsal or anterolateral fixation system (e.g., icotec Pedicle System). The KONG®-TL VBR System is a modular design featuring an expandable body, extensions, and end plates with various heights, widths, and angles. The system consists of expandable body structures that range in height from 19 to 96 mm, have a diameter of 19 mm and surface treads/spikes on its cranial and caudal end plate surfaces that serve to guide and anchor the implant. The system also consists of rectangular and round end plate configurations. The end plate round configuration has a geometry that ranges from 0°, 4°, 8° and 12° and size that ranges from 26 to 43 mm. The end plate rectangular configuration has geometry that ranges from 0°, 4°, 8° and 12° and size that ranges from 33 to 52 mm. The end plates are locked with a screw onto the main body. The tread surfaces and spikes help to improve primary fixation stability of the end plates. The large contact surface of the end plates reduces the risk of migration. The screw for fixation of the end plates to the body has a length of 6 mm and a thread size of M8.

The KONG®-TL VBR System is made of BlackArmor® material, a carbon fiber reinforced polyetheretherketone (Carbon/PEEK) composite. The BlackArmor® material is a combination of continuous, high strength carbon fiberreinforced PEEK and icotec's composite flow molding (CFM) process. The result is a non-metallic implant component with an interwoven 3D fiber architecture that provides strength and endurance. BlackArmor® is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts. Embedded tantalum markers (per ASTM F560) ensure the required radiologic visibility of the implant during surgery and follow-up. The KONG®-TL VBR System incorporates a rough cp-titanium coating (per ASTM F1580), designed to improve direct bone apposition.

The partially hollow geometry of the implants (endplates and extension) allows them to be packed with bone graft. The implants are supplied sterile and are available in a variety of heights, footprints and anatomical shapes to accommodate patient anatomy.

KONG®-C VBR System: The KONG®-C VBR System is a vertebral body replacement system for anterior stabilization of the cervical spine. This device serves as a replacement for vertebral bodies in tumorous and traumatic diseases which lead to instabilities in the anterior support or compression of neural structures or diseases that make an infection repair necessary. The KONG®-C VBR System is a modular design with various heights, widths, and angles. The system consists of a lordotic body structure that ranges in height from 5 - 55mm with a width and depth of 13mm, and surface treads on its cranial and caudal end plate surfaces that serve to guide and anchor the implant. The overall height of the VBR device including body and end plates ranges from 16 to 66 mm. The end plates have a geometry that range from 0 to 6° and are manufactured in the following sizes: 14 x 13mm, 16 x 13mm. and 18 x 14mm. The tread surfaces help to improve primary fixation stability of the end plates. The large contact surface of the end plates reduces the risk of migration. The screw to secure the end plates to the body has a length of 7 mm and a thread size of M6.

The KONG®-C VBR System is composed of BlackArmor® material, a carbon fiber reinforced polyetheretherketone (Carbon/PEEK) composite. The BlackArmor® material is a combination of continuous, high strength carbon fiberreinforced PEEK and icotec's composite flow molding (CFM) process. The result is a non-metallic implant component with an interwoven 3D fiber architecture that provides strength and endurance. BlackArmor® is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts. Embedded tantalum markers (per ASTM F560) ensure the required radiologic visibility of the implant during surgery and follow-up. The KONG®-C VBR System incorporates a rough cp-titanium coating (per ASTM F1580), designed to improve direct bone apposition.

The implants are supplied sterile and are available in a variety of heights, footprints and anatomical shapes to accommodate patient anatomy.

The provided text is a 510(k) summary for the KONG®-TL VBR System and KONG®-C VBR System, which are vertebral body replacement systems. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. Therefore, the requested information about acceptance criteria, detailed study design, expert qualifications, and AI/ML specific details (e.g., effect size of AI assistance, training set details) are not typically found in this kind of regulatory submission.

However, I can extract the information that is present and indicate where the requested details are not applicable or provided in this document.

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical and clinical data.

The relevant statement is:
"Non-clinical testing data and clinical data demonstrate the performance of the subject device is substantially equivalent to that of the predicate device, and support the performance of the subject device in its expanded indications for use."

2. Sample size used for the test set and the data provenance

The document mentions "clinical data provided" and "non-clinical testing data," but it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It also states: "the provided clinical data did not support that the specific material or unique technological characteristics of the subject device components provides additional benefit relative to other vertebral body replacement devices for the indications for use related to infection."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as it is not an AI/ML device performance study.

4. Adjudication method for the test set

This information is not provided in the document as it is not an AI/ML device performance study.

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 as the device is a physical vertebral body replacement system, not an AI/ML medical device designed to assist human readers.

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

This is not applicable as the device is a physical vertebral body replacement system, not an AI/ML medical device.

7. The type of ground truth used

The document refers to "clinical data" and "expanded indications for use," but does not explicitly define the type of ground truth used (e.g., pathology, outcomes data) in the context of device performance validation beyond demonstrating substantial equivalence. For a physical implant, "ground truth" would typically relate to the success of the implant in its intended function post-surgery, which is usually assessed through long-term follow-up and clinical outcomes. The document does not detail how this was established.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the document describes a physical medical device.

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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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C-VBR is a vertebral body replacement device indicated for use in the cervical spine (spanning C2-T1 vertebral bodies) 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 C- VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The C-VBR System is also 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.

C-VBR is a vertebral body replacement device manufactured from titanium alloy (Ti-6AI-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. C-VBR is a single-piece device manufactured using electrical discharge machining. having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach. C-VBR is to be used in combination with supplemental fixation indicated for use in the cervical spine. C-VBR is provided with superior and inferior endplates that are either parallel (no lordosis) or angled to provide intrinsic lordosis (9.6° or 11.5°), and with various heights from 16 mm to 72 mm.

This document describes the regulatory approval of the C-VBR vertebral body replacement device. The approval is based on a demonstration of substantial equivalence to previously marketed predicate devices, rather than a separate clinical study with predefined acceptance criteria for the C-VBR device itself. Therefore, many of the requested details about acceptance criteria, specific study design for the C-VBR, and AI-related aspects are not directly applicable or available in this document.

However, I can extract the relevant information regarding the performance testing and clinical data review that were used to support the substantial equivalence.

Here's a breakdown of the available information:

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

Since this is a substantial equivalence submission relying on predicate devices and specific performance tests, there aren't explicit acceptance criteria for the C-VBR in the format of "minimum sensitivity X, specificity Y." Instead, the acceptance is based on demonstrating mechanical performance equivalent to or better than the predicate devices and a review of clinical outcomes from actual device use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size (Clinical Data Review): 97 patients treated with a total of 103 C-VBR devices.
• Data Provenance: The document does not specify the country of origin. It is a "review of the results of a series of 97 patients." This implies retrospective data collection, reviewing existing patient records or a previous study. It does not appear to be a newly conducted prospective clinical trial for this specific 510(k) submission.

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)

Not applicable. The clinical data presented is a review of outcomes from actual patient treatments, likely relying on the assessments of the treating physicians and radiologists involved in those cases, rather than a separate "ground truth" expert panel specifically for this 510(k) submission. No information is provided about the number or qualifications of experts involved in the original patient care or the subsequent review mentioned in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This was a review of existing clinical outcomes, not a study involving independent readers or adjudication for a diagnostic accuracy assessment.

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 device is a surgical implant (vertebral body replacement) and the submission does not involve Artificial Intelligence (AI) or an MRMC study.

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

Not applicable. This device is a surgical implant and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The clinical performance was assessed based on outcomes data including:

• Nurick Classification scores (mobility restriction assessment)
• Cobb angle measurements (cervical sagittal alignment)
• Radiographic evidence (absence of significant subsidence, evidence of fusion)
• Absence of device-related complications or revision surgeries.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The design and validation relied on engineering principles and comparison to predicate devices, not a training set in the context of AI.

9. How the ground truth for the training set was established

Not applicable.

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