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The SpineView X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.

The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The SpineView X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a caqe implant and instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes to accommodate varying anatomy and can expand to the desired lordosis. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295.

The SpineView X-Pac Expandable Lumbar Cage System implants are singleuse, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before use.

This document is a 510(k) premarket notification decision letter from the FDA regarding the SpineView X-Pac Expandable Lumbar Cage System. It does not describe an AI medical device or a study involving acceptance criteria for such a device.

The document discusses:

• The FDA's decision that the SpineView X-Pac Expandable Lumbar Cage System is substantially equivalent to a legally marketed predicate device.
• The regulatory classification and product code for the device.
• Indications for Use of the SpineView X-Pac Expandable Lumbar Cage System.
• A brief device description: an intervertebral body fusion device made of medical-grade titanium alloy, single-use, provided non-sterile, and intended to be cleaned and steam sterilized before use, with reusable instruments.
• A mention of mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) conducted in accordance with specific guidance documents and ASTM standards to demonstrate substantial equivalence to the predicate.

There is no mention of:

• Acceptance criteria in terms of AI/algorithm performance (e.g., sensitivity, specificity, AUC).
• A study proving a device meets such acceptance criteria.
• Sample sizes for test or training sets for an AI algorithm.
• Data provenance for AI models.
• Experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human reader improvement with AI.
• Standalone algorithm performance.
• How ground truth was established for training data.

Therefore, I cannot provide the requested information based on the provided text, as it pertains to a traditional medical device (an implantable cage system) and not an AI/software as a medical device (SaMD).

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