Search Results

The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer is made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System also includes bone screws to secure the device to the vertebral body.

This document is a 510(k) Premarket Notification from the FDA regarding the "Reliance Cervical IBF System." It is primarily a regulatory approval document and does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested for AI/medical device performance evaluation.

The document pertains to an intervertebral body fusion device and confirms its substantial equivalence to previously marketed predicate devices (K120396, K131429, K142269 & K172489). The "Non-Clinical Testing" section mentions that the system has undergone mechanical testing according to ASTM standards (ASTM F-2077, ASTM F-2267, and ASTM Draft F-04.25.02.02). However, it does not provide specific acceptance criteria or performance results from these tests. These are standard tests for mechanical integrity of implants, not for AI performance.

Therefore, I cannot provide the requested information as it is not present in the provided text. The questions regarding sample size, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, and training set information are all relevant to the evaluation of AI models or diagnostic devices, which this document does not describe. This is a physical implant device, not an AI or diagnostic software.

Ask a specific question about this device