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When intended for pedicle screw fixation from L1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

PathFinder is a modification to the existing Spinal Concepts Inc. InCompass polyaxial screw design. The design modification allows the components to be implanted through an open or mini open surgical technique. The mini-open surgical technique is conducted using k-wires and cannulated PathFinder screws.

The information provided is for the Spinal Concepts, Inc. PathFinder, which is a medical device (spinal fixation system) and not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (like those requested in the prompt regarding sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets, etc.) is not applicable here.

The provided document describes a 510(k) submission for a design modification of an existing spinal fixation system. The assessment for such a device focuses on mechanical testing, biocompatibility, and substantial equivalence to a predicate device, rather than AI/ML performance metrics.

Specifically, the document states:

• MECHANICAL TEST DATA: "Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements."

This indicates that the device's acceptance criteria are related to its mechanical performance and safety, as demonstrated through compliance with specific ASTM standards. The study mentioned is a series of mechanical tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML metrics, nor can I answer questions about sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies, as these concepts do not apply to this type of device and the information provided.

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