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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 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.

InSight constructs consist of bone screws, lock screws, connectors, swivels, and rods, which when assembled create a polyaxial range of motion. InSight only allows the placement of 5.5 mm titanium rods. InSight screws may be implanted in an open manner; or via cannulation, which allows a subset of procedures to be completed through a mini open procedure.

The provided text describes the "Spinal Concepts, Inc. InSight™ Pedicle Screw System" and details its indications for use and mechanical testing. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device.

The document is a 510(k) summary for a medical device (spinal pedicle screw system), which is a physical implant, not a software device. Therefore, the concepts you've asked about (AI/ML device performance, test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not relevant to this type of submission and are not present in the text.

The text does mention "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." These design requirements would serve as the "acceptance criteria" for this mechanical device, and the ASTM testing would be the "study" proving it. However, specific values for these criteria and reported performance are not detailed in this summary.

Therefore, I cannot provide the requested information based on the given input, as it pertains to a different type of medical device evaluation.

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