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The Capless Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3and 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 Capless Pedicle Screw System is 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).

Capless rods are 5.5 mm diameter solid cylinders with spherically rounded ends. provided in 40 mm, 60 mm, 100 mm, 120 mm, 140 mm, 160 mm, 160 mm, 200 mm, and 300 mm lengths.

Each Capless pedicle screw assembly consists of a pedicle screw, yoke, and screw cap. Self-tapping pedicle screw assemblies are provided in diameters of 5.5 mm, 6.5 mm. and 7.5 mm. The 5.5 mm diameter screw assemblics are provided in lengths of 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. The 6.5 mm diameter screw assemblies arc provided in lengths of 40 mm, 45 mm, 50 mm, and 55 mm. The 7.5 mm diameter screw assemblies are provided in lengths of 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 ınm.

The Capless cross bar assembly is an optional component and can be used for additional stabilization. Cross bar assemblies are available in lengths from 25 mm to 81 mm.

The rods, pedicle screws and transverse links of the Capless Pedicle Screw System are made of titanium alloy conforming to ASTM F136.

I am sorry, but the provided text describes a 510(k) Premarket Notification for a Capless™ Pedicle Screw System, which is a medical device. This type of document focuses on establishing substantial equivalence to a predicate device and outlines the device's design, materials, and intended use.

The text does not contain information about:

• Acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) for a digital health device or AI.
• A study proving the device meets acceptance criteria, as would be conducted for a software or AI-based medical device.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

Therefore, I cannot provide the requested table and information based on the given input as it pertains to a mechanical medical device, not a software or AI-powered one that would typically undergo the kind of validation described in your query.

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