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The Stryker Spine TRIO® PS is a posterior, noncervical (T10-S1), pedicle system 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 spine: severe spondylolisthesis (grades 3 and 4) at LS-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) turnor, pseudoarthrosis, and previous failed fusion. The Stryker Spine TRIO® PS is also a sacral screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and previous failed fusion.

The Stryker Spine TRIO® PS is comprised of spinal screws, plates and locking components. The components are available in a variety of sizes in order to accommodate patient anatomy and are fabricated from titanium alloy. The components of the TRIO® PS System will be provided non-sterile.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe any study that proves a device meets such criteria.

The document is a 510(k) summary for the Stryker Spine TRIO® PS, which is a spinal fixation appliance. It primarily focuses on the device description, predicate devices, intended use, and a declaration of substantial equivalence to previously cleared devices. It states that "Testing to demonstrate compliance with FDA's Guidance 'Spinal System 510(k)s'', May 3, 2004 was completed for the Stryker Spine TRIO® PS," but it does not provide any details about the specific tests, acceptance criteria, or results of those tests.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details.

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