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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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CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CoreLink Robotic Navigation Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of CoreLink Pedicle Screw System implants (NextGen Pedicle Screw System, CoreLink Midline Fixation System (CentraFix), and Tiger Spine System). The instruments are manufactured from stainless steel.

The provided document is a 510(k) summary for the CoreLink Robotic Navigation Instruments. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. As such, the focus of the submission is primarily on demonstrating this substantial equivalence through engineering analysis and comparison to existing cleared devices, rather than on extensive clinical performance data or a standalone performance study as would be seen for novel AI/ML-enabled devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance (beyond engineering analysis for equivalence), sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document states:

• "The CoreLink Robotic Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate."

This means the device's acceptable performance is demonstrated by its similarity to already cleared devices, and it's not being assessed as a novel AI/ML device requiring the robust performance study details typical for such submissions.

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The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

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

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

• The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

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)

• This question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

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

• This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

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 question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

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

• The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

8. The sample size for the training set

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

• This question is not applicable for the same reason mentioned in point 8.

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