(70 days)
The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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 the 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® family and Xia 4.5 Systems and SR90D System.
The purpose of this submission is to expand the use of the OASYS® System to include the use of screws in the posterior cervical spine.
The provided text is a 510(k) summary for the Stryker OASYS® System, a spinal fixation device. It outlines the device's indications for use, technological characteristics, and a summary of performance data. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new AI/software-based medical device study.
Therefore, most of the requested information regarding acceptance criteria, specific study design details like sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or software devices, cannot be found in this document.
However, I can extract the following information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in the typical sense for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence through mechanical testing and comparison with predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance | Demonstration of substantial equivalence to predicate devices through: |
- Published literature
- Mechanical testing per ASTM F1717 (Static/Dynamic Compression Bending)
- Mechanical testing per ASTM F1798 (Static/Dynamic Torsion) |
| Material/Geometric Equivalence | The subject OASYS® System shares the same materials, geometries, and fundamental scientific technologies as the predicate devices. None of these characteristics have been altered, augmented, or otherwise changed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a medical device for spinal fixation, and the "test set" refers to mechanical testing of the physical device, not an AI model's dataset. The document does not provide sample sizes for the mechanical tests, nor does it refer to data provenance in the context of clinical data.
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. This is a physical medical device. "Ground truth" in this context would implicitly refer to established engineering standards for mechanical strength and durability. Expertise is inherent in the design, manufacturing, and testing process against these standards, but the document does not specify a number of experts for "ground truth" establishment in the way it would for clinical AI validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a physical medical device. Mechanical testing results are objective measurements against established standards, not subject to human adjudication methods like those used for expert consensus in clinical image interpretation.
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 document pertains to a physical spinal fixation system, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance of this physical device is based on established engineering standards (ASTM F1717 & F1798) for mechanical testing (static/dynamic compression bending; static/dynamic torsion) and the characteristics of legally marketed predicate devices by which substantial equivalence is claimed.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of an AI/software study.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned or implied for this physical medical device.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.