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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 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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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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