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The Preference Pedicle Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis) and/or spinal deformities such as scoliosis, kyphosis or excessive lordosis.

In addition, when used as a pedicle screw fixation system, the Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the Preference Pedicle Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The Preference Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, hooks, connectors and rods. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-Eli) or Cobalt Chrome.

The provided text does not contain any information about acceptance criteria or a study that demonstrates the device meets these criteria.

The document is a 510(k) summary for the "Preference Pedicle Screw System," indicating it's a submission to the FDA for market clearance. It details:

• Contact Information: Trace Cawley, US Spinal Technologies.
• Trade Name: Preference Pedicle Screw System.
• Classification: Pedicle screw spinal system (21 CFR §888.3070), Spinal intervertebral body fixation orthosis (§888.3060), Spinal interlaminal fixation orthosis (§888.3050).
• Class: II.
• Product Codes: KWO, KWP, MNH, MNI.
• Indications for Use: Detailed descriptions for both pedicle screw fixation and posterior, non-cervical, non-pedicle screw fixation systems in the lumbar and/or sacral spine.
• Device Description: Comprised of monoaxial and polyaxial pedicle screws, hooks, connectors, and rods, manufactured from medical grade titanium alloy or Cobalt Chrome.
• Predicate Device(s): US Spinal Technologies Preference Pedicle Screw System (K081296), DePuy Expedium Spine System (K073364, K041119 and K033901), and Stryker Xia Spinal System (K080928 and K060361).
• Substantial Equivalence: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Missing Information:

The document focuses on establishing substantial equivalence to previously cleared devices based on similar indications for use, design, function, and materials. It does not describe a study involving specific acceptance criteria and performance metrics in the way requested for medical device software or AI systems.

Therefore, I cannot provide the requested table or answer any of the questions (1-9) regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text. This device is a physical implant, and its clearance relies on established equivalence to existing devices, not typically on performance metrics derived from clinical studies with ground truth in the same way an AI diagnostic tool would.

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