Search Results

The Kodiak Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the Kodiak Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the Kodiak Lumbar Spacer System.

The Kodiak Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

The provided text describes the 510(k) premarket notification for the "Kodiak Lumbar Spacer System," an intervertebral body fusion device. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI).

The requested information pertains to studies proving device performance with AI, such as acceptance criteria for AI model performance, sample sizes for AI training and test sets, expert adjudication methods for AI ground truth, and AI-assisted reader studies. Since the Kodiak Lumbar Spacer System is a physical implant and not an AI-powered diagnostic or therapeutic tool, this document does not contain any of the information requested about AI device performance studies.

The "Performance Data" section lists several types of mechanical tests performed on the device in accordance with ASTM standards (e.g., Static Compression, Dynamic Compression, Subsidence, Expulsion). These tests are standard for orthopedic implants to demonstrate their structural integrity and function, but they are not related to AI performance.

Therefore, I cannot provide the requested information because the provided document does not discuss an AI device or its performance studies.

Ask a specific question about this device

The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The AUDERE Lumbar Spacer System consists of implants and trials that are compatible with all previously cleared AUDERE instruments. The AUDERE Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

The provided text describes a medical device, the AUDERE Lumbar Spacer System, and its FDA 510(k) clearance (K193457). However, the document does not contain information about acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving device performance in the context of AI.

This document is for a physical implantable medical device (intervertebral body fusion device), not a software or AI-driven diagnostic/treatment device. The performance data section refers to non-clinical mechanical testing (e.g., static axial compression, dynamic axial compression, expulsion, subsidence) demonstrating the physical strength and durability of the implant, not the diagnostic or analytical performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/algorithm device from the provided text. The questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

Ask a specific question about this device