Search Results

The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

This document is a 510(k) Summary for a medical device called the "Pyrenees Cervical Plate System, Semi-constrained Screw." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "mechanically tested," implying physical testing, but does not provide details on the number of devices or components tested.
• Data Provenance: The study is described as "mechanical testing" and "comparison to predicate systems and other currently marketed systems." This is laboratory-based testing, not human patient data. Therefore, questions of country of origin or retrospective/prospective are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study (mechanical testing for substantial equivalence of a spinal implant) does not typically involve human "experts" establishing a clinical ground truth in the way a diagnostic AI might. The "ground truth," in this case, is defined by the objective performance standards of ASTM F1717 and the characteristics of the predicate devices. The "experts" involved would be engineering and regulatory professionals performing and analyzing the mechanical tests and comparing specifications, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication for data interpretation. The "adjudication" is based on meeting the defined mechanical test standards and comparing physical and functional characteristics to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a 510(k) submission for a physical medical device (spinal implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Mechanical Performance Standards: Specifically, ASTM F1717 for mechanical testing.
• Predicate Device Specifications: The documented design features, materials, and intended uses of previously cleared, legally marketed spinal plate systems.
• Regulatory Definitions: The FDA's criteria for substantial equivalence under 510(k).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device