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The EVOS Lumbar Interbody System (EVOS device) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The EVOS Lumbar Interbody System is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

The EVOS Lumbar Interbody System is an Intervertebral Body Fusion System for the lumbar spine. The EVOS Lumbar Interbody System includes surgical instruments to deliver the EVOS devices via a Posterior or Transforaminal approach. The generally rectangular design of the EVOS device incorporates an internal cavity for insertion of biological bone growth material through the top and bottom openings, as well as four small transverse holes (two on each side) that are designed to enhance bony ingrowth. Each device has a series of ridges or "teeth" on the top and bottom surfaces that are designed to ensure strong anchoring on the vertebral body endplates and resist backing out of the implant. The EVOS devices are provided sterile (gamma irradiated) for single use.

The EVOS device is made of radiolucent PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced material. In addition, tantalum beads are embedded in the spacers to allow for radiographic visualization. The geometric shape of the EVOS devices are categorized as either STRAIGHT, CURVED, or ROTATE. All are available in a range of sizes, as well as flat and biconvex endplates, and with various degrees of lordosis to accommodate variations in patients' anatomy. Most of the EVOS STRAIGHT devices are offered with an option of a Standard nose, Wide nose, or Narrow nose. The devices are available in various heights, widths, and lengths to accommodate various surgical technique options.

The provided text describes the EVOS Lumbar Interbody System, an intervertebral body fusion device, and its substantial equivalence to predicate devices, but does not contain information about studies related to acceptance criteria for a device that relies on artificial intelligence (AI) or machine learning.

The document is a 510(k) summary for a medical device approval. It focuses on:

• Device Description: The physical characteristics, material, and types of the EVOS Lumbar Interbody System.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Comparison to Predicate Devices: How the EVOS system is similar to other legally marketed devices, primarily regarding technological characteristics and indications for use.
• Performance Data: Lists mechanical testing performed on the device to demonstrate its structural integrity and safety. These are standard tests for spinal implants.

Therefore, I cannot provide the requested information regarding AI acceptance criteria or studies proving performance based on this document. The questions you posed (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are highly relevant to AI/ML medical devices, which this document does not cover.

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