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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. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (TI - S1/Illium) 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, 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 based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning AI/ML performance metrics, a test set, expert involvement, or training data.

The document is a 510(k) premarket notification from the FDA to Ortho Development Corporation for their Ibis™ Pedicle Screw System. It primarily focuses on the substantial equivalence of this pedicle screw system to previously marketed predicate devices. The information provided is standard for a medical device clearance and includes:

• Device Description: What the Ibis™ Pedicle Screw System is made of and how it works.
• Indications for Use: The medical conditions it is intended to treat.
• Technological Characteristics: How it compares to predicate devices in terms of materials, screw types, and mechanisms.
• Non-Clinical Testing: References to static and dynamic compression and torsion testing performed according to ASTM F1717.
• Conclusion of Substantial Equivalence: Based on similarities in intended use, design, materials, manufacturing, packaging, and mechanical test results.

This document does not involve any AI/ML components, and therefore, the specific questions regarding acceptance criteria for AI/ML performance, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

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