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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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icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System Navigated Instruments.

icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation® in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays.

The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDAcleared icotec pedicle screws cleared under K222789. K200596. K193423 and K190545.

This document is a 510(k) Premarket Notification from the FDA regarding the VADER® Pedicle System Navigated Instruments. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text does not contain the detailed information requested regarding acceptance criteria and the specifics of the study proving the device meets those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

• Missing: The document only generally states that "Performance Testing" was conducted to "verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments." It does not provide specific quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or their corresponding reported performance values.

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

• Missing: The document mentions "anatomical and navigated simulated use and accuracy and reliability testing" but does not specify the sample size of the test set (e.g., number of simulated procedures, number of anatomical models, number of measurements). It also does not provide data provenance (e.g., country of origin, retrospective or prospective).

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

• Missing: This information is not provided.

4. Adjudication method for the test set:

• Missing: This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• Missing: The document does not describe an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The device is a set of navigated instruments, not an AI diagnostic tool that assists human readers in interpreting data.

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

• Not applicable/Missing: The device is a set of navigated instruments for use during surgery with a navigation system (Medtronic StealthStation®), which inherently involves a human surgeon. It's not an algorithm that performs actions "standalone" without human interaction. The performance testing likely evaluated the accuracy and reliability of the instruments in conjunction with the navigation system and human use, not as a standalone algorithm.

7. The type of ground truth used:

• Missing: The document describes "anatomical and navigated simulated use" but does not explicitly state how ground truth was established for these tests (e.g., a "true" anatomical position determined by a gold standard method before navigation, or a reference measurement).

8. The sample size for the training set:

• Not applicable/Missing: The document describes a medical device (navigated instruments), not a software or AI model that typically has a training set. Therefore, there is no "training set" in the context of this device.

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

• Not applicable/Missing: Similar to point 8, there is no training set for this type of device.

Summary of what is provided:

• Device Name: VADER® Pedicle System Navigated Instruments
• Intended Use: To be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. Designed for use with stereotactic navigation system Medtronic StealthStation®.
• Performance Testing Mentioned: "one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the VADER® Pedicle System Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock™ tracker and SureTrak®II clamps and arrays, and to demonstrate substantial equivalence to the predicate instruments."
• Conclusion: The device was demonstrated to be substantially equivalent to the predicate device (VERTICALE® Navigation Instruments, K223649) with respect to indications, design, and performance, based on the performance testing.

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