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The ISOLA Spinal System is a pedicle screw system intended to provide 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The additional ISOLA Spinal components are connectors, open and closed iliac screws, iliac bolts, and anqled closed iliac screws. These components have been designed to allow for rigid fixation of the sacral, iliac and pelvic regions of the spine. The ISOLA Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text is a 510(k) summary for the ISOLA Spinal System, a medical device. It describes the device, its intended use, and indicates that performance data was submitted. However, it does not contain specific acceptance criteria or a detailed study description to prove the device meets said criteria.

The document states: "PERFORMANCE Performance data were submitted to characterize the DATA: ISOLA Spinal System components." This indicates that performance testing was conducted and the results were provided to the FDA, but the summary itself does not elaborate on the specific tests, criteria, or outcomes.

Therefore, I cannot provide the requested information based solely on the input text. The information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications is not present in this document.

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