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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Stryker Spine OASYSTM 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 .
• Atlanto/axial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• 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 (T1-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 Spine Oasys System can be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.

This submission is intended to address a line extension to Stryker Spine OASYS™ System. The line extension includes a new range of Titanium alloy axial & parallel rod-to-rod connectors, standard hooks & rods as well as new CP Titanium rods. The new range of Titanium alloy axial and parallel rod-to-rod connectors will also facilitate the linkage between Stryker Spine OASYS™ and SR90D Systems.

The provided text describes a 510(k) submission for a line extension to the Stryker Spine OASYS™ System. It focuses on the mechanical and design equivalence to a predicate device rather than clinical performance or acceptance criteria based on device performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance (especially clinical performance with metrics like sensitivity, specificity, or reader improvement) is not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" appear to be based on the substantial equivalence to a predicate device (Stryker Spine OASYS™ System (K032394)) with respect to:

• Indications for Use: The subject components share the same indications for use as the predicate device.
• Material: The subject components share the same material (Titanium alloy) as the predicate device.
• Basic Design Concepts: The subject components share basic design concepts as the predicate device.
• Mechanical Properties: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."

Therefore, the reported "performance" is that the new components are comparable or equivalent to the predicate device in these aspects. No specific numerical performance metrics are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This was a 510(k) for a line extension of an existing spinal fixation system, relying on mechanical equivalence and material properties rather than clinical performance data from a test set of patient cases. No clinical test set data or provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set was described that would require expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set was described.

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 medical device (spinal fixation system), not an AI/software device. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device (spinal fixation system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for this submission was based on the specifications and performance of the predicate device, demonstrated through mechanical testing for "comparable mechanical properties."

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm is mentioned.

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