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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -13), the Stryker Spine OASYS® System is intended for:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation o
• Atlanto/axial fracture with instability
• Occipitocervical dislocation -.
• Revision of previous cervical spine surgery .
• t Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The Stryker Spinc OASYS® System can also be linked to the Xia" System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. 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 Stryker Spine OASYS® System can also be linked to the Xia® System. SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.

This Special 510(k) submission is intended to introduce a line extension to the predicate OASYS® System, which consists of the addition of a new midline occiput plate, bone screws. and a Vitallium® rod

The provided text is a 510(k) summary for a line extension to the Stryker Spine OASYS® System. It describes the device, its intended use, and a comparison to predicate devices, but does not include any information about acceptance criteria or a study proving the device meets those criteria.

The filing is a "Special 510(k)" which implies that the device is a modification of an already cleared device and demonstrates substantial equivalence through design controls and performance testing. However, the details of these tests, acceptance criteria, and their results are not present in the provided document.

Therefore, I cannot fulfill your request for the following information based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a spinal fixation system, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Testing has demonstrated that the additional midline occiput plate, bone screws and Vitallium® rod have equivalent mechanical properties to the predicate OASYS® System K032394. K072568, and K052317." This statement indicates that mechanical testing was performed to show equivalence, but the specifics of that testing (e.g., test methods, parameters, acceptance criteria, raw data) are not detailed in this summary.

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