Search Results

The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacro-lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The ostaPek Interbody Fusion Cages system consists of four families of cages used with four surgical approaches: the Erriva® ELIF/TLIF Cage (Extraforaminal Lumbar Interbody Fusion/ Transforaminal Lumbar Interbody Fusion), the Gemitra® TLIF Cage, the PLIF Cage (Posterior Lumbar Interbody Fusion) and PLIF Bullet Cage, and the ALIF Cage (Anterior Lumbar Interbody Fusion). All device configurations are available in multiple sizes to adequately fit patient anatomical variations. They all have bone graft windows, ridges or teeth to resist migration, and x-ray markers.

This document is a 510(k) Premarket Notification for a medical device called "ostaPek Interbody Fusion Cages." It is not a document about an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, and explicitly states: "No clinical studies were performed."

The request asks for details specific to the evaluation of an AI/ML medical device, which are not applicable to the traditional medical device clearance process described in this document.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device