(90 days)
The Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation.
The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
The Spineology Facet Screw System is designed to provide bilateral transfacet fixation of the lumbar facet joints. The cannulated screw is available partially or fully threaded in a range of lengths and is made from medical grade titanium alloy that complies with ASTM F-136.
The provided document is a 510(k) summary for the Spineology Facet Screw System, a medical device. It does not describe the acceptance criteria or a study proving the device meets those criteria, as an AI/ML device would need to.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, which is a different type of approval process. The criteria typically discussed in such a summary are related to device design, materials, intended use, and performance characteristics, comparing them to already approved devices rather than establishing novel performance metrics for AI.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, AI/ML study details (test set, ground truth, experts, MRMC, standalone performance, training set) because this submission is for a physical medical device (facet screws) and does not involve AI/ML technology or associated performance studies.
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