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The LOSPA IS Spinal Fixation Systems are intended to provide immobilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, The LOSPA Spinal Fixation Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The LOSPA IS Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The LOSPA® ISTM Spinal Fixation System consists of an assortment of pedicle screws, set screws, lateral offsets, bone screws and screw bodies. The LOSPA® ISTM Spinal Fixation System implants are not compatible with components or metal from any other manufacturer's system.

I am unable to find the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document appears to be a 510(k) premarket notification approval letter for a medical device, which primarily focuses on establishing "substantial equivalence" to existing predicate devices rather than providing detailed acceptance criteria and performance study results in the format requested.

The "Performance Data" section mentions that "Performance testing - mechanical testing was carried out to demonstrate substantial equivalence and the subject device performed either similar or better than comparable predicate devices." It also lists the types of mechanical tests performed (e.g., ASTM F1717, ASTM F543) but does not provide specific acceptance criteria or the reported device performance values for these tests within the document.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, ground truth, expert qualifications, or MRMC studies. This type of detailed performance data is typically found in the full 510(k) submission, which is not included here.

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