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Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text is a 510(k) summary for the Lucent® 3D Spinal System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the performance of an AI/ML-based device against specific acceptance criteria derived from a clinical study.

Therefore, the information required to answer your request (acceptance criteria for an AI/ML device, details of a study proving it meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) is not present in the provided text.

The document discusses:

• Device Description: Intervertebral body fusion devices, box-shaped with "teeth", made from titanium alloy.
• Indications for Use: Spinal fusion for degenerative disc disease (DDD) at L2-S1, with or without Grade 1 spondylolisthesis/retrolisthesis, requiring supplemental spinal fixation and bone graft.
• Substantial Equivalence: Comparison to predicate devices (Lucent® K150061, OmegaLIF K150395) based on indications, surgical technique, design, manufacturing, and materials.
• Performance Data: Lists various mechanical tests (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear, Subsidence) performed according to ASTM standards, concluding that "All data indicates that the device will perform as intended."

In summary, the provided document does not contain the information requested about a study for an AI/ML device's acceptance criteria.

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