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510(k) Data Aggregation
(44 days)
Z-LINKPC System
The Z-LINKpc System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
To achieve additional levels of fixation, the Z-LINKsc System may be connected to the Zavation Spinal System using rod connectors and tapered rods.
When used with the occipital plate, the Z-LINKpc System is also intended to provide immobilization and stabilization for the occipito-cervico-thoracic juction (occiput-T3) in treatment of the instabilities mentioned above, including occipitocervical dislocation.
The Z-LINKsc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets, occipital plates, bone screws, and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
This document describes the Z-LINKpc System, a medical device, and its marketing authorization, not an AI/ML powered device. As such, the information requested regarding acceptance criteria and study proving the device meets those criteria (especially related to AI/ML specific aspects like training/test sets, ground truth establishment, expert adjudication, or MRMC studies) is not present in the provided text.
The document discusses the substantial equivalence of the Z-LINKpc System to legally marketed predicate devices based on:
- Indications for Use: The intended purpose of the device (immobilization and stabilization of spinal segments as an adjunct to fusion for various instabilities).
- Technological Characteristics: Basic design (rod-based fixation system), materials (titanium alloy/cobalt chrome alloy), mechanical safety, and performance.
- Performance Data: Static compression bending and torsion, dynamic compression bending, and dynamic torsion tests performed according to ASTM F2706 on a worst-case construct.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance evaluation as the provided text does not contain that information. The "acceptance criteria" here are implicitly the demonstration of substantial equivalence to predicate devices through mechanical performance testing and similar indications for use and technological features.
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(169 days)
Z-LINKPC System
The Z-LINK.pc System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Z-LINKPC System may be connected to the Zavation System using rod connectors and tapered rods.
The Z-LINKمc System is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consist of polyaxial screws, hooks, rods, cross-connectors, rod connectors, offsets and cap screws. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
The provided text is a 510(k) summary for the Z-LINKpc System, a medical device for spinal fixation. It describes the device, its intended use, and states that performance data was collected. However, it does not contain specific acceptance criteria, detailed study results, or information about how ground truth was established, or the involvement of experts, or MRMC studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document only states the following regarding performance data:
"Static axial compression bending and torsion, and dynamic axial compression bending test were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip test were performed according to ASTM F1798 on the connectors. The mechanical test results demonstrated the Z-LINKoc system performs as well as or better than the predicate devices."
This indicates that mechanical tests were performed to compare the device to predicate devices, but the specific numerical acceptance criteria, raw performance data, or details about the study design that would address your questions are not present in this document.
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