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The Integra® Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

This is a medical device application for an intervertebral body fusion device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not applicable in this context.

Here's a breakdown of why the requested information cannot be provided given the input:

• Device Type: The Integra Expandable IBD System is a physical medical implant (intervertebral body fusion device) made of PEEK, titanium, and cobalt chromium. It is not a software algorithm or an AI/ML diagnostic tool.
• Regulatory Pathway: This is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices. This pathway typically relies on non-clinical (bench) testing and comparison to existing devices, rather than large-scale clinical trials or AI/ML performance studies with specific acceptance criteria like sensitivity, specificity, etc.
• Non-Clinical Testing: The submission explicitly states "Non-clinical Testing: The Integra Expandable IBD System demonstrated equivalent performance to the predicate systems through static and dynamic axial compression shear testing per ASTM F2077, with wear evaluation per ASTM F1877, subsidence testing per ASTM F2267, and expulsion testing per ASTM Draft F04.25.0202. In addition, a cadaver implantation study was conducted to demonstrate usability and graft containment/volume of the subject device."
• Clinical Testing: The submission explicitly states "Clinical Testing: No clinical testing was required to demonstrate equivalence."

Therefore, I cannot populate the table or answer the questions as they pertain to AI/ML device validation. The provided document concerns a traditional medical device demonstrating substantial equivalence through non-clinical performance standards and a cadaver study, not through a study involving AI performance metrics, readers, or ground truth as defined in an AI context.

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