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When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
When used as a lumbar intervertebral fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The basic shape of the Cervical and Lumbar GPS™ devices is a structural column having upper and lower implant openings and a central cavity for autograft bone. The cervical devices have a "B" shaped cross-section. The PLIF devices are rectangular having a pyramidal anterior surface. The TLIF device cross-section is curved having a wedged leading face. For all devices, surface teeth assist in the seating the implant between the vertebral bodies. Each device type is available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided document is a 510(k) summary for the GPS™ Spacers, an intervertebral body fusion device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on technological characteristics and performance data.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The "Performance Data" section specifically states: "Mechanical testing of the worst case GPS™ Spacers was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. Expulsion testing was performed. The mechanical test results demonstrate that the GPS™ Spacer performance is substantially equivalent to the predicate devices."

This indicates that the performance data presented is related to mechanical and material properties of the physical intervertebral fusion device, not the performance of an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes relevant to an AI/ML device study, as that information is not present in the provided text.

Based on the nature of the device (intervertebral body fusion device), it is a physical implant and not an AI/ML-driven diagnostic or therapeutic device. The typical metrics, study designs, and ground truth methodologies for AI/ML devices (like sensitivity, specificity, MRMC studies, expert adjudication for image analysis) are not applicable here.

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