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The LDR Spine ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

The LDR Spine ROI-C Cervical Cage System consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.

The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed supplemental fixation - the ROI-C VerteBRIDGE anchoring plate. The anchoring plate, made of titanium alloy (TiA16V4) can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The anchoring plate locks securely in place to the PEEK implant via locking tabs on either side of the anchoring plate.

The ROI-C PEEK cages are available in two shapes - an anatomic design with a curved superior surface and a lordotic design with flat superior and inferior surfaces to create 7° of lordosis. The device is manufactured from medical grade PEEK OPTIMA® LT1

The purpose of the subject 510(k) was to expand the indications to include use with allograft.

This document is a 510(k) summary for the LDR Spine ROI-C Cervical Cage System, a medical device. It describes an expanded indication for use of an existing device to include allograft. Therefore, the device in question is a physical implant, not an AI/ML device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The document focuses on demonstrating substantial equivalence for an intervertebral body fusion device and its expanded use with allograft based on clinical literature review.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set information) are all relevant to the evaluation of AI/ML-driven medical devices. Since this document concerns a physical implant and not an AI/ML device, these specific details are not present.

The "Performance Testing" section states:

• "Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the LDR Spine ROI-C Cervical Cage System."
• "The published clinical outcomes demonstrated that the use of allograft (i.e., cancellous and/or corticocancellous bone graft) in cervical interbody fusion devices to treat patients diagnosed with cervical degenerative disc disease as defined above, poses no new risks to patients."
• "No new mechanical tests were performed since there were no design changes to the device."

This indicates that the "study" for this submission was a literature review, not a performance study of an AI/ML algorithm.

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