(78 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), 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
• 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). 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® 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 Xia® II and Xia® 3 System 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.
This document is a 510(k) Premarket Notification from the FDA to Stryker Corporation regarding their OASYS® System for spinal interlaminal fixation. It is a clearance letter and a 510(k) summary, not a study evaluating device performance against acceptance criteria in the way a diagnostic AI device or software might be assessed.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided text. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and engineering analysis, rather than clinical performance metrics.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "engineering analysis" to show that new longer length transition rods do not affect performance, but does not provide specific acceptance criteria or performance metrics for the OASYS system itself.
- Sample sized used for the test set and the data provenance: Not applicable. The "study" mentioned is an "engineering analysis," not a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this type of submission is typically based on pre-established engineering standards and comparisons to predicate devices, not on expert consensus from a clinical test set.
- Adjudication method: Not applicable.
- 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 device, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: For this type of device, the "ground truth" for substantial equivalence is derived from established mechanical and material properties, and comparison to the predicate device's design and performance.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.