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510(k) Data Aggregation
(101 days)
The Valeo™ Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Valeo™ Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
The Valeo™ Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Valeo™ Cervical Plate System is manufactured from wrought Ti-6A1-4V in accordance with ISO 5832-3.
The provided text describes a medical device, the "Valeo™ Cervical Plate System," and its 510(k) clearance by the FDA. However, it does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, or direct performance metrics for the device itself.
Instead, the document states:
- Performance Standards: "Testing performed on this device indicates that the Valeo™ Cervical Plate System is substantially equivalent to predicate devices. ASTM F1717 performance standards were adhered to and all applicable requirements were met."
This indicates that the device's substantial equivalence was established by demonstrating adherence to a recognized ASTM standard (F1717) and by comparison to existing predicate devices, rather than through a clinical study that measures specific acceptance criteria against reported device performance, as would be expected for an AI/CADe device.
Therefore, I cannot fulfill your request for the specific details outlined (points 1-9) because the provided text does not contain that type of information for this device submission. The device is a physical spinal fixation system, not an AI/CADe system, and its clearance relies on substantial equivalence and adherence to engineering standards for medical implants.
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(104 days)
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.
Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (The document does not specify quantitative acceptance criteria for clinical or diagnostic performance, nor does it report such performance metrics.) | (The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, but this is not reported in terms of clinical performance metrics like sensitivity, specificity, or accuracy.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable (No test set for clinical performance is described).
- Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).
4. Adjudication method for the test set
- Not applicable (No adjudication method is 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
- No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.
8. The sample size for the training set
- Not applicable (No training set is mentioned as this device is not an AI/ML product).
9. How the ground truth for the training set was established
- Not applicable (No training set or associated ground truth establishment is mentioned).
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(30 days)
The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified screws to the ORION® Anterior Cervical Plate System.
The provided text is a 510(k) summary for the ORION® Anterior Cervical Plate System, focusing on the inclusion of modified screws into an existing system. This document is a regulatory submission for a medical device and describes its intended use and claims of substantial equivalence to a predicate device.
It does not contain any information regarding clinical studies, acceptance criteria for device performance (such as sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, or details about ground truth establishment.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria and study details based on the provided text. The document focuses on regulatory approval based on equivalence to a previously cleared device, not on new clinical performance data from a standalone study.
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