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The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:

The JASPER Spinal Fixation System II is indicated for the following:

• Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Stenosis
• Pseudoarthrosis
• Failed previous fusion

The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 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.

In addition, the JASPER Spinal Fixation System II is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The JASPER Spinal Fixation System II is a top-loading multiple component, posterior(thraco-lumbar) spinal fixation system which consists of screws, hooks, rods, set screws, cross links, rod connectors and iliac connectors for spinal deformity system. The JASPER Spinal Fixation System II will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

All products are made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) and CoCrMo alloy(Cobalt-28Chromium-6Molybdenum, ASTM F1537) approved for medical use.

The provided text is a 510(k) summary for a medical device (The JASPER Spinal Fixation System II) and does not contain information about acceptance criteria or a study proving that a device meets such criteria, especially regarding AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, material, scientific technologies, and intended use. It explicitly states: "No new mechanical testing was performed as no non-previously cleared components were added to the JASPER Spinal Fixation System II." This indicates that the submission relies on the prior clearances of its predicate devices and does not present new performance data for the device itself or any AI/ML component.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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