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The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.

The Cogent Lateral Interbody consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.

The Cogent Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.

The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.

The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.

This document is a 510(k) summary for the Cogent Lateral Interbody System, an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to existing predicate devices. Consequently, it does not contain details about acceptance criteria, the study proving the device meets those criteria, or clinical performance metrics in the way typically required for AI/ML device evaluations.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the Cogent Lateral Interbody System is substantially equivalent to predicate devices (Cogent Med-LIF System and Cogent Med-LIF XL System) based on indications for use, technological characteristics, and performance testing.
• Device Description: Materials (PEEK, Ti-6Al-4V, Tantalum), dimensions, and general design.
• Non-Clinical Testing: A "Cadaveric Usability Study" is mentioned, but no details of acceptance criteria or performance results are provided.
• Clinical Testing: Explicitly states, "No clinical studies were performed."

Therefore, based on the provided text, I cannot answer the specific questions regarding acceptance criteria, study methodologies, and performance metrics as they would apply to an AI/ML device or a device requiring new clinical efficacy data. The information requested (Table of acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this 510(k) summary because the approval is based on substantial equivalence to existing devices that have already demonstrated safety and effectiveness, rather than novel clinical performance data for this specific device.

The only "study" mentioned is a "Cadaveric Usability Study" under non-clinical tests, and no details about its methodology, acceptance criteria, or results are provided.

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