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The Ibex™ Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Ibex™ is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ibex™ Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The IbexTM Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.

As an intervertebral body fusion device, the Ibex™ Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Ibex™ Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Ibex™ Spinal System may also be implanted using the Accuvision System to provide the surgeon with a minimally invasive approach for posterolateral spinal surgery.

The Ibex "Spinal Spacer is a curved device constructed of either Titanium alloy or medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

The provided document is a 510(k) summary for the Biomet Spine's Ibex™ Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices for a medical implant, not on evaluating the performance of an AI or software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove adherence to those criteria for an AI-powered device. The questions you've asked are typically relevant for AI/SaMD submissions, which involve clinical performance metrics and ground truth establishment.

Specifically, the document discusses:

• Device Description: The physical characteristics and materials of the Ibex™ Spinal System.
• Indications for Use: The medical conditions and anatomical locations for which the device is intended.
• Summary of Technologies: States that the technological characteristics (material, design, sizing) are similar to predicate devices.
• Substantial Equivalence: Asserts that the Ibex™ Spinal System is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, principles of operation, and mechanical testing.

There is no mention of:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
• A study specifically designed to assess these AI performance metrics.
• Sample sizes for test or training sets for an AI.
• Data provenance, expert qualifications, or adjudication methods for ground truth in an AI context.
• MRMC studies or standalone AI performance.
• Types of ground truth for AI algorithms.

The study mentioned is "mechanical testing," which is standard for spinal implants to ensure structural integrity and biocompatibility, not for evaluating an AI's diagnostic or predictive capabilities.

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