(23 days)
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 t 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 also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors.
This 510(k) adds new polyaxial screw components (non-biased and cancellous styles) to the existing OASYSTM System. The new polyaxial screws of the Stryker Spine OASYSTM System are identical to the existing polyaxial screws of the OASYS™ System with regard to materials, intended use, and basic operating principles. The new polyaxial screws differ from the existing OASYS™ polyaxial screws with regard to specific design features; however, mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems.
The provided text is a 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS™ System. This document focuses on the substantial equivalence of device modifications (new polyaxial screw components) to existing predicate devices, demonstrating equivalence through mechanical testing.
Therefore, this type of submission (a 510(k) for a device modification) does not typically involve the kinds of studies and data points (such as AI performance metrics, expert adjudication, ground truth establishment, or multi-reader multi-case studies) that would be relevant for a new diagnostic or AI-powered medical device.
The study described here is mechanical testing to demonstrate the equivalence of the modified components to the predicate devices.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI-focused detailed response:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices (OASYS™ System) | "mechanical testing has demonstrated that OASYS™ Systems constructed with the new screws perform equivalently to one or more of the cited predicate device systems." |
| Materials equivalence to predicate devices (OASYS™ System) | "identical to the existing polyaxial screws of the OASYS™ System with regard to materials" |
| Intended Use equivalence to predicate devices (OASYS™ System) | "identical to the existing polyaxial screws of the OASYS™ System with regard to... intended use" |
| Basic operating principles equivalence to predicate devices (OASYS™ System) | "identical to the existing polyaxial screws of the OASYS™ System with regard to... basic operating principles." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size for the mechanical testing.
- Data Provenance: Not specified. Mechanical testing is typically laboratory-based, not reliant on human clinical data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Mechanical testing for medical devices relies on engineering standards and measurements, not expert consensus for "ground truth" in the clinical sense.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Mechanical testing involves objective measurements rather than subjective adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation, not for mechanical device components.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This document concerns a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: For mechanical testing, the "ground truth" is defined by established engineering standards, material properties, and biomechanical performance specifications. These are objective and measurable, not derived from clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This submission describes mechanical testing for device modification, not a machine learning model.
9. How the ground truth for the training set was established
- Training Set Ground Truth: 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.