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510(k) Data Aggregation
(120 days)
When intended as an adjunct to fusion in skeletally mature patients using allograft and/or autograft of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed prev10us fusion and/or tumors
Occipitocervical Components Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only The screws are not intended to be placed in the cervical spine
Occipitocervical constructs require bilateral fixation to C2 and below Note Segmental fixation is recommended for these constructs
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine
Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3 The screws are not intended to be placed in the cervical spine
Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors Refer to the CD HORIZON® Spinal System package insert for a hist of the CD HORIZON® Spinal System indications of use
The VERTEX Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Allov (Nitinol ~ NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.
This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal implant device. It primarily discusses the device's description, indications for use, and substantial equivalence to existing predicate devices.
This document does not contain information on acceptance criteria, device performance, or any study involving human or even simulated data to prove the device meets specific performance criteria. It focuses on regulatory approval based on substantial equivalence to previously approved devices and mechanical testing results.
Therefore, I cannot provide a detailed response to your request, as the necessary information for acceptance criteria and a study proving their fulfillment is not present in the provided text.
Specifically, the document states:
- "VI. Substantial Equivalence Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices..."
- "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."
This indicates that the main "proof" for this submission was demonstrating substantial equivalence through comparison to legally marketed devices and equivalent mechanical testing, rather than a clinical performance study with specific acceptance criteria.
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(182 days)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical construct require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and or/cobalt chromium with ataless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi) - Thane Memory Alloy is compatible with titanium, titanium alloy, and cobalt chrom. Shippe only. Some multi-axial screws contain elastomeric stakes made of silicore adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedia and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. It describes the device, its indications for use, and its substantial equivalence to other legally marketed devices.
However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The "V. Substantial Equivalence" section mentions: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." This indicates that some form of testing was done to demonstrate equivalence, likely mechanical strength or fatigue testing, but the specific acceptance criteria and detailed results are not provided in this summary.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other detailed information about a study based on the provided text. The document is a regulatory summary, not a detailed study report.
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(99 days)
When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;
- DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Failed previous fusion
- Tumors
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -- T3) spine.
The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.
The S4 Spinal System is a medical device for spinal fusion. The 510(k) summary provided does not contain explicit acceptance criteria or the details of a study proving the device meets said criteria in the format requested. Instead, it indicates that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' was completed where applicable."
Therefore, I cannot provide a direct answer to your request in the specified format from the provided text excerpt. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with acceptance criteria.
However, I can extract information related to what aspects were considered for the 510(k) clearance, which implicitly implies that the device is expected to meet the performance standards set by the predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text. The document states that "All required testing per [guidance document] was completed where applicable." This implies that standard tests relevant to orthopedic devices were performed, but the specific acceptance criteria for each test and the numerical performance results are not detailed.
2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "testing" but does not specify the sample sizes or the nature of the data (e.g., in vitro, in vivo, clinical trial, retrospective, prospective, country of origin).
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 given text. Since the document does not describe a clinical study with a "test set" requiring ground truth established by experts, this detail is absent.
4. Adjudication method for the test set:
This information is not provided in the given text. As there is no described clinical study, an adjudication method for a test set is not mentioned.
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 information is not provided in the given text. The S4 Spinal System is a mechanical implant, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant to this device and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given text. As the device is a spinal implant, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
7. The type of ground truth used:
This information is not explicitly provided in the given text. Given that the clearance is based on substantial equivalence to predicate devices and adherence to general guidance for orthopedic devices, the "ground truth" would likely be derived from established biomechanical testing standards, material property tests, and the clinical history and performance of the predicate devices.
8. The sample size for the training set:
This information is not provided in the given text. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to this device as described.
9. How the ground truth for the training set was established:
This information is not provided in the given text, for the same reason as point 8.
Summary of available information regarding performance:
- Performance Data: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' were done where applicable." This indicates that the device underwent mechanical and material testing to demonstrate its safety and effectiveness, consistent with regulatory requirements for similar orthopedic implants.
- Substantial Equivalence: The S4 Spinal System is deemed substantially equivalent in design to the following predicate devices:
This means that the S4 Spinal System's performance characteristics are considered comparable to these cleared devices, implying that it meets similar performance expectations and safety profiles. The specific "acceptance criteria" for the S4 Spinal System would therefore align with those established for its predicate devices and the relevant FDA guidance.
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