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The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.

The provided document is a 510(k) summary for the Stryker Corporation's OASYS® System, a medical device for spinal fixation. It details the device's indications for use and a summary of its technological characteristics. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for an AI/CADe device.

Instead, this 510(k) submission is related to establishing substantial equivalence between the current OASYS® System and previously cleared predicate devices (K150539 and K150753). The "Summary of Performance Data" section explicitly states:

"This submission seeks to reconcile the expansion of indications cleared under K150539 with the new implants cleared under K150753. Therefore, no additional performance data is necessary."

This indicates that the submission is focused on regulatory alignment and modifications to existing, cleared devices rather than providing new performance data from a prospective study to demonstrate effectiveness against specific acceptance criteria for a new or novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies from this document. This kind of information is typically found in the "Performance Data" or "Clinical Studies" sections of a 510(k) summary when a new device or significant modification requires such evaluations to demonstrate substantial equivalence.

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