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The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.

The MONARCH Commercially Pure Titanium Spinal Rod is a 6.35mm diameter rod available in various lengths.

The provided text describes a 510(k) submission for the MONARCH Spine System Commercially Pure Titanium Spinal Rod. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device, as required for 510(k) clearances. The text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

Instead, the "Performance Data" section merely states: "Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod." This typically refers to mechanical, material, or biocompatibility testing required for a physical medical device, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request for information related to acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.

The document pertains to the regulatory clearance of a physical spinal rod, not an AI/ML diagnostic or predictive device.

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