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The VADER® Pedicle System:

The VADER® Pedicle System is 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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 fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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

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

VADER®one Pedicle System:

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

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of:

• Polyaxial cannulated, fenestrated pedicle screws,
• Polyaxial, cannulated, pedicle screws, ●
• Curved. straight. S-rods. J-rods. ●
• Connectors .

The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

Based on the provided text describing the VADER® Pedicle System and VADER®one Pedicle System, it's clear this document is an FDA 510(k) clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness of a new technology.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria, performance studies involving AI, human readers, ground truth establishment, or sample sizes related to AI/algorithm development. The performance testing mentioned is confined to "Bench testing consisting of static axial gripping capacity testing and static torque gripping capacity per ASTM 1798 and dynamic compression bending per ASTM F1717 was successfully completed," which are mechanical performance tests, not clinical or AI-related studies.

In summary:

• There is no mention of acceptance criteria and reported device performance related to an AI/software component. The "acceptance criteria" discussed implicitly by the FDA in a 510(k) context are those for establishing substantial equivalence to a predicate, primarily through material, design, and mechanical performance comparisons.
• There is no data regarding a "test set" for an AI or imaging algorithm. The "study" described is bench testing of the pedicle system's mechanical properties.
• No experts, ground truth, or adjudication methods are discussed in the context of clinical AI performance.
• No MRMC comparative effectiveness study or standalone algorithm performance is described.
• The type of ground truth used is not applicable as this is not an AI/imaging device. The "ground truth" for this device would be its physical properties meeting standards and its successful mechanical performance.
• No training set for an AI algorithm is mentioned.
• Ground truth for a training set is not applicable.

This document pertains to the market clearance of a pedicle screw system, primarily based on its mechanical performance and substantial equivalence to existing devices, not on the performance of an AI or imaging diagnostic algorithm.

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The icotec Anterior Cervical Plate System is 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 (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

When used with the icotec Cervical Cage or the KONG®-C VBR System, the icotec Anterior Cervical Plate 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.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate tantalum markers per ASTM F560.

The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18 mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94 mm. The plates are precontoured to fit patient anatomy. The screw holes in the plates are conical and threaded.

The icotec Anterior Cervical Plate System self-tapping screws are available in diameters of 4.0 and 4.25 mm with lengths of 13 and 15 mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

This document describes the regulatory clearance (K233215) for the icotec Anterior Cervical Plate System. The information provided focuses on the device's technical specifications and the basis for its substantial equivalence to a predicate device, rather than detailed performance study results against specific, quantifiable acceptance criteria.

The provided text does not contain a detailed study with specific acceptance criteria and reported device performance in the format of a table as requested. Instead, it presents a summary of non-clinical and clinical data supporting substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information, noting limitations due to the nature of the available document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter for a 510(k) submission typically does not present performance data in a detailed table against pre-defined acceptance criteria, especially for a device seeking substantial equivalence based on prior clinical data without a de novo clinical trial. Instead, it refers to a summary of performance testing and clinical data that broadly supported substantial equivalence.

The document explicitly states: "However, 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 anterior cervical plate devices for the indications for use related to infection." This suggests that while equivalence was shown, superiority or additional benefit for specific aspects (like infection) was not demonstrated. |
| Substantial Equivalence | The device was demonstrated to be substantially equivalent to the predicate device (K201587) with respect to indications for use, intended use, design, and performance, based on non-clinical testing data and clinical data. The subject and predicate devices are stated to have similar technological characteristics, be made of similar materials, and are packaged/sterilized by identical methods. The conclusion is that the device is substantially equivalent. |

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

• Sample Size for Test Set: Not specified in the provided text. The document refers to "clinical data provided" but does not detail the size or nature of this dataset in terms of individual patients or cases used for the "test set" (if a distinct test set was even explicitly defined in the context of this 510(k) submission).
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not available in the provided document. The clearance letter mentions "clinical data" but does not detail how ground truth was established for any specific test set, or the number and qualifications of experts involved in such a process.

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

• This information is not available in the provided document.

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 document describes a spinal implant device (Anterior Cervical Plate System), not an AI/software device that would involve human readers or AI assistance in interpretation. Therefore, an MRMC study related to AI assistance would not be applicable in this context.

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

• This document concerns a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

• For a spinal implant device seeking 510(k) clearance based on substantial equivalence, the "ground truth" would typically refer to established clinical safety and effectiveness from the predicate device and the clinical data supporting the subject device's performance. This would involve "outcomes data" and potentially clinical assessments, but the specific methodology (e.g., expert consensus on outcomes) is not detailed here. The document states "clinical data provided supports a substantially equivalent safety and effectiveness profile."

8. The sample size for the training set:

• This concept of "training set" is relevant for AI or machine learning models. This document is about a physical medical device. Therefore, a "training set" in that context is not applicable.

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

• As above, the concept of a "training set" for ground truth establishment is not applicable to this type of device.

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icotec Cervical Cage: The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-T1) 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. When used with the icotec Anterior Cervical Plate System, the icotec Cervical Cage is intended to stabilize the cervical spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec PLIF Cage: The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec PLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

icotec ETurn® TLIF Cage: The icotec ETurn® TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by radios. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec ETurn TLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn® TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a rough titanium coating. The devices are intended to be used with supplemental spinal fixation. There is one type of cervical cage and two lumbar cages (i.e., PLIF and ETurn® TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and/or lordosis angles to accommodate patient anatomy.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification clearance letter from the FDA for the icotec Interbody Cage System, which primarily focuses on device description, indications for use, and a statement of substantial equivalence to predicate devices. It mentions "Performance Testing" but only states that clinical data supports substantial equivalence and explicitly notes that the data did not support additional benefit for infection-related indications due to the specific material or technological characteristics. No specific acceptance criteria or details of a study (like sample size, ground truth, expert qualifications, etc.) are provided.

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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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The VADER® Pedicle System is 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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

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

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the "VADER® Pedicle System." This document is a clearance letter and a summary of the device's indications for use and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies to assess device performance against specific metrics. The document states that "Clinical data was presented to support the expanded indications for use," and that this data "supports a substantially equivalent safety and effectiveness profile for the use of thoracolumbosacral pedicle screw instrumentation for the indications for use." However, it does not detail the nature of this clinical data or how it was used to establish performance against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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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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The VADER® Pedicle System is 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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 fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets specific performance criteria in the context of an AI/ML device. The document is an FDA 510(k) clearance letter for a medical device, specifically the VADER® Pedicle System and G21 Cement, which are physical implants and bone cement, not an AI/ML diagnostic or therapeutic device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The "Performance Testing Summary" section (Page 6) briefly mentions mechanical testing performed per ASTM standards (F1717, F1798, F543/F2193) and cement injection testing for the VADER® Pedicle System and G21 Cement. These are engineering performance tests for a physical device, confirming its structural integrity and functional characteristics, not clinical performance metrics for an AI/ML algorithm. The conclusion states that the device is "substantially equivalent" to predicate devices based on these mechanical tests.

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The icotec Anterior Cervical Plate System is 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 (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

This document is a 510(k) premarket notification for a medical device, the icotec Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving that the device meets specific performance criteria for an AI/ML product. Therefore, the requested information regarding acceptance criteria for AI/ML device performance, ground truth establishment, training sets, and MRMC studies is not present in this document.

The document details the device's indications for use, its description, and the predicate devices used for comparison. It also lists performance testing that was conducted, which primarily involves mechanical biocompatibility and structural integrity tests relevant to a spinal implant, not an AI/ML algorithm.

Here's a breakdown of the information that is available, and why the requested AI/ML specific information is absent:

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

• Acceptance Criteria (Mechanical/Biocompatibility): The document states that "The nonclinical tests performed by the company, including static compression, static torsion and dynamic compression per ASTM F1717, met the pre-defined acceptance criteria." However, the specific numerical acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not provided in this summary.
• Reported Device Performance (Mechanical/Biocompatibility): Similarly, the actual numerical results of these tests are not reported in this summary, only the qualitative statement that they "met the pre-defined acceptance criteria."

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

• Not Applicable for this type of device: This information typically pertains to clinical studies for AI/ML devices or drugs. For this mechanical implant, "sample size" would refer to the number of devices tested for mechanical properties, which is not detailed in this summary. There is no "data provenance" in the sense of patient data for an AI/ML algorithm.

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: Ground truth establishment by experts is a concept for AI/ML model validation, not for the mechanical testing of a spinal plate.

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

• Not Applicable: Adjudication methods are used in clinical trials or AI/ML evaluations to resolve disagreements among readers/experts. This is not relevant to 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: MRMC studies are used to evaluate diagnostic performance, especially for AI/ML algorithms assisting human readers. This device is a mechanical implant, not a diagnostic AI/ML tool.

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

• Not Applicable: This refers to the performance of an AI/ML algorithm in isolation. This device is a physical implant.

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

• Not Applicable (for AI/ML context): For mechanical testing, the "ground truth" would be engineering specifications and ASTM standards.

8. The sample size for the training set

• Not Applicable: There is no AI/ML model being trained for this device.

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

• Not Applicable: There is no AI/ML model being trained for this device.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) demonstrating substantial equivalence based on mechanical and biocompatibility testing, not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML specific acceptance criteria, study methodologies, and ground truth establishment are not addressed in this document.

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When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 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 fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.

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

The purpose if this Traditional 510(k) is to seek marketing clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System.

V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components:

• The powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
• The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.

The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-Steady bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-Fast has a low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile. The sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The sterilization process is ethylene oxide and it has been properly validated. Preparation and application procedures of the subject devices are detailed within the labeling as Mixing Phase, Waiting Phase, Application Phase, Setting/Hardening Phase.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

This document is a 510(k) Premarket Notification from the FDA, which outlines the substantial equivalence of medical devices (G21 Cement and VADER® Pedicle System) to already legally marketed devices. It primarily focuses on the device's intended use, description, and performance testing summaries for mechanical and material properties, rather than AI/algorithm-based diagnostic or prognostic performance.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/algorithm performance (e.g., sample size for test set, expert consensus for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.

The acceptance criteria and performance studies detailed in this 510(k) summary are for the physical and mechanical properties of the bone cement and pedicle screw system.

Here's a breakdown of the relevant information from the document that loosely relates to your request, but is specific to the mechanical device, not an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table" for acceptance criteria as one would expect for an AI algorithm. Instead, it lists the types of performance testing conducted, implying that the acceptance criteria are adherence to the specific ASTM standards and demonstration of substantial equivalence to predicate devices. The reported performance is that the devices met these standards and were found substantially equivalent.

Note: The document states "The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices." This is the reported performance against the implied acceptance criteria of meeting or exceeding the predicate device's performance based on these standards.

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

• Sample Size: Not explicitly stated for each test. For mechanical testing (ASTM standards), the sample size would typically be a specific number of devices/implants per test as required by the standard. This is not "data" in the sense of patient data.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from in vitro mechanical and material testing conducted by the manufacturer (icotec ag) in Switzerland. The "clinical data" mentioned is not detailed, but for a 510(k), it often refers to references to existing literature or limited clinical use data, not necessarily new prospective studies for the 510(k) itself unless specified.

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

• Not applicable. Ground truth as typically understood for AI-based diagnostic/prognostic devices (e.g., radiological interpretation) is not relevant here. The "ground truth" for these tests comes from objective physical measurements and adherence to engineering standards.

4. Adjudication method for the test set:

• Not applicable. This is not a human interpretation task.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This is for mechanical device performance, not AI assistance for human readers.

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

• Not applicable. This is a PMMA bone cement and pedicle screw system, not an algorithm.

7. The type of ground truth used:

• For mechanical tests: Objective physical measurements against established ASTM standard specifications.
• For biocompatibility: Adherence to relevant biocompatibility standards.
• For "Clinical Data": Details are not provided, but it likely refers to existing literature/clinical experience with similar devices or limited clinical data demonstrating safety and performance.

8. The sample size for the training set:

• Not applicable. This document is not about an AI/ML algorithm.

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

• Not applicable. This document is not about an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance for a mechanical medical device (bone cement and pedicle screws). The "acceptance criteria" and "proof" relate to standard engineering, material, and biocompatibility testing, demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.

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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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