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The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open posterior approach. saqAlian Lumbar Cage implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The sagAlign Lumbar Cage System is an interbody expandable lumbar cage. It is implanted by a posterior approach and supported by posterior fixation which is required to achieve fusion. The lumbar cages can be gradually expanded to reach the height chosen by the surgeon, allowing restoration of disc height and the ideal lordosis.

The sagAlign Lumbar Cages are delivered non-sterile packaged. The cages are available in several sizes in different heights, widths, and lengths. One or two cages may be implanted for each treated level. The sagAlign Lumbar Cages will be composed of titanium alloy and may have a surface treating of Promimic HAnano Surface (hydroxyapatite (HA) coating). The Promimic HAnano Surface coated cages are only available sterile.

Reusable instruments to support implantation of the subject device are provided with non-sterilization trays.

This document is a 510(k) premarket notification for a medical device called the "sagAlign Lumbar Cage System." It is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML powered device that would typically have the detailed types of studies you are asking for.

Therefore, the information you requested regarding acceptance criteria, study details for an AI/ML device, and performance metrics like sensitivity, specificity, or MRMC studies for AI assistance, is not present in this document.

This document describes a spinal implant (intervertebral body fusion device) and focuses on the following to demonstrate substantial equivalence:

• Indications for Use Comparison: Showing the new device has similar indications to existing ones.
• Technological Comparison: Detailing how the design, materials, surgical approach, and mechanisms are similar to predicate devices.
• Non-Clinical Tests Summary & Conclusions: This section mentions mechanical testing (static compression, static compression-shear, dynamic compression-shear, and subsidence testing) performed according to ASTM standards (ASTM F2077, ASTM F2267). These tests are to ensure the mechanical strength and fatigue endurance of the lumbar cage are comparable to predicate devices.

In summary, as this document pertains to a physical medical implant and not an AI-powered diagnostic or assistive tool, it does not include the detailed AI/ML study information you are asking for (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, or specific AI acceptance criteria).

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