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The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Integrity Implants' FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

The provided text is a 510(k) summary for the FlareHawk Interbody Fusion System, an implantable medical device. It describes the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the mechanical and biocompatibility testing performed to demonstrate substantial equivalence.

This document does not contain information on the acceptance criteria or study details related to device performance as it would be relevant for a digital health/AI device. The provided text refers to an implantable medical device (Intervertebral body fusion device) which undergoes different types of testing to demonstrate safety and effectiveness. The questions in the prompt, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," and "Standalone (algorithm only without human-in-the-loop performance) study," are specifically designed to evaluate AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot extract the requested information from the provided document as it pertains to a different type of medical device and regulatory submission.

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