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The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate surgical needs and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws. The subject 510(k) adds additional 3-screw plates to the system.

This document describes the FDA's 510(k) clearance for the EMERGE™ Anterior Cervical Plate System. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

However, the provided text does not contain information related to an AI/ML-driven medical device. It describes a traditional implanted medical device (a spinal plate system). Therefore, it is not possible to answer the specific questions about acceptance criteria, study design, ground truth, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the information given in the document.

The document focuses on:

• Device Type: Anterior Cervical Plate System (a mechanical implant).
• Purpose: Spinal fixation.
• Regulatory Pathway: 510(k) clearance, establishing substantial equivalence to existing predicate devices.
• Performance Data: Mechanical testing (static compression, static torsion, dynamic compression) according to ASTM F1717, demonstrating compliance with performance criteria for Spinal Plating Systems.

In summary, this document does not provide the information needed to answer your questions about the acceptance criteria and study proving an AI/ML device meets those criteria.

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The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate a variety of spinal levels based on surgical need and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle or variable angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws.

The provided text describes a 510(k) premarket notification for the EMERGE™ Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device based on indications, design, materials, function, manufacturing, and performance.

However, the document does not contain any information about an AI/ML-based device, nor does it mention any studies involving acceptance criteria and performance metrics for such a device. The device described is a physical medical implant (a cervical plate system) designed for surgical use. Therefore, it's not possible to answer your specific questions relating to AI/ML device performance, ground truth, expert adjudication, or MRMC studies from the provided text.

The closest relevant information is contained in the "Performance Data" section on page 5, which states:

"Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647."

This indicates that the performance of the physical device was evaluated against established engineering standards (ASTM F1717) and FDA guidance for spinal plating systems. However, these are mechanical and material performance tests, not AI/ML model performance evaluations.

Ask a specific question about this device