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The Ibis® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ilium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Ibis® Pedicle Screw System consists of bulleted rods; cannulated polyaxial, monoaxial, extended length (Ibis® XL) and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis® Pedicle Screw System maintains compatibility with the Pagoda Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, the study that proves the device meets those criteria, or any details about an AI algorithm or its performance.

The document is an FDA 510(k) premarket notification for the "Ibis® Pedicle Screw System," specifically focusing on a line extension (Ibis® XL Cannulated Polyaxial Screws). It discusses:

• Device Name and Classification: Ibis® Pedicle Screw System, Class II, Regulation Number 21 CFR 888.3070 (Thoracolumbosacral pedicle screw system).
• Indications for Use: Provides immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, tumor, failed fusion, spinal stenosis, spinal deformities).
• Substantial Equivalence: The primary purpose of the document is to demonstrate substantial equivalence to previously cleared predicate devices (Ibis® Pedicle Screw System K142146, Pagoda® Pedicle Screw System K131785, and additions to EXPEDIUM® and VIPER® Systems K101993).
• Device Description: Components, materials (Titanium Alloy), and compatibility with other systems.
• Nonclinical Test Summary: Mentions mechanical tests performed (Static Compression Bending, Dynamic Compression Bending, Axial Torque Gripping Capacity) in accordance with ASTM standards, to support the device's mechanical integrity and performance, aligning with equivalence to predicate devices. These are engineering performance tests, not clinical performance or AI performance.

Therefore, I cannot answer your specific questions regarding acceptance criteria, AI study details, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

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