(195 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 or 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; Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and 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 also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and polyaxial screws of 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® Spinal System, Xia 4.5 System and SR90D System.
This Special 510(k) submission is intended to introduce a line extension to the predicate OASYSTM System, which consists of the addition of the saddle connector.
This document focuses on a Special 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS® System, specifically the addition of a saddle connector. As such, the acceptance criteria and study described are for the mechanical performance of the device and its components, not for an AI/software device or a comparative effectiveness study in a clinical setting.
Here's a breakdown of the requested information based on the provided text:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance and Study Description |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate devices in terms of material, design, mechanical performance, and indications for use. Specific tests include: |
- Static Compression Bending
- Dynamic Compression Bending
- Static Torsion
- Dynamic Torsion | "Documentation is provided which demonstrates that the new component of the Stryker Spine Oasys System to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Static Compression Bending testing, Dynamic Compression Bending testing, Static Torsion testing and Dynamic Torsion testing per ASTM F 1717 were conducted on the Oasys System components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes (e.g., number of saddle connectors or spinal constructs tested). It notes "Oasys System components" were tested. Mechanical performance testing typically involves multiple samples for statistical validity, but the precise numbers are not provided.
- Data Provenance: The data is generated from in vitro laboratory mechanical testing, conducted in compliance with ASTM F1717. The country of origin of the data is not explicitly stated but would likely be where Stryker Spine conducts its R&D and testing, presumably in the US based on the submission to the FDA. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.
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)
This question is not applicable to this type of submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards established by ASTM F1717 and the FDA's guidance document for spinal systems. The "experts" are the engineers and technicians who conduct the tests and compare the results to established benchmarks and predicate device performance. Explicit numbers or qualifications of such experts are not details typically included in a 510(k) summary for mechanical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable to a mechanical performance study. Adjudication methods like "2+1" typically refer to reconciling expert opinions in clinical or image-based studies. For mechanical testing, the "adjudication" is based on objective measurements and comparison against pre-defined acceptance criteria (e.g., within a certain percentage of predicate device performance, or exceeding minimum strength requirements).
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
This question is not applicable. This 510(k) is for a physical medical device (surgical implant component) and its mechanical performance, not a software/AI device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This 510(k) is for a physical medical device and its mechanical performance, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is defined by:
- ASTM F1717 Standard: This standard specifies the methodology and parameters for testing spinal implant constructs. Adherence to this standard ensures a defined benchmark for testing.
- Predicate Device Performance: The performance of the predicate device serves as the direct comparative "ground truth" for demonstrating substantial equivalence. The new component's mechanical performance is considered acceptable if it is substantially equivalent to that of the already-marketed predicate device.
- FDA Guidance: The "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004" provides the regulatory framework and recommendations for demonstrating substantial equivalence for spinal systems.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML study that uses training sets. The "training" in mechanical testing refers to the established testing methodologies and standards (ASTM F1717).
9. How the ground truth for the training set was established
This question is not applicable as there is no "training set" in the context of this mechanical performance study. The standards (ASTM F1717) and regulatory guidance (FDA) serve as the established benchmarks against which the device's performance is measured, ensuring safety and effectiveness through substantial equivalence to predicate devices.
§ 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.