Search Results

The Omega 21™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an unterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The Omega 21™ System is a rod system spinal fixation device. The components of the system are manufactured from Ti-6Al-4V ELI per ASTM F136.

The provided text describes the Omega 21™ System, a spinal fixation device, and its 510(k) summary for safety and effectiveness. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

The document primarily focuses on:

• Device Description: What the Omega 21™ System is.
• Intended Use/Indications for Use: The medical conditions and patient types for which the device is intended.
• Materials: What the device components are made from.
• Comparison to Predicate Devices: How it is similar to other legally marketed spinal fixation systems.
• FDA Clearance Details: The FDA's decision regarding substantial equivalence, specific limitations, warnings, and regulatory requirements.

The "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements" statement (in section 7) is the closest thing to a "study" mentioned. However, this is a very general statement about mechanical testing for a physical device, not a performance study for an AI/ML system with quantifiable metrics like sensitivity, specificity, or F1-score against a ground truth dataset, which are typical for your requested format.

Therefore, I cannot extract the specific information requested in your bulleted list (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided text is about a physical medical device (spinal fixation system) and its regulatory clearance, not an AI/ML-driven diagnostic or prognostic device.

Ask a specific question about this device