(23 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 (TI-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.
The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and an occiput plate. 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 Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® Spinal System, Xia 4.5 System and SR90D System via the rod-to-rod connectors.
This Special 510(k) submission is intended to introduce a line extension to the predicate OASYS™ System, which consists of the addition of a cross connector plate and associated components (connector blocker and nut).
The provided text is a 510(k) Premarket Notification for a line extension to the Stryker Spine OASYS® System, introducing a cross connector plate and associated components. This document is not for a new medical device that utilizes AI or produces performance metrics in the way your request describes. Therefore, most of the requested information regarding acceptance criteria and studies proving the device meets them (especially related to AI performance, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this type of submission.
Here's a breakdown of what can be extracted from the document based on your request, and why other parts are not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical properties equivalent to predicate device. | "Testing has demonstrated that the additional cross connector components have equivalent mechanical properties to the predicate OASYS® System (K032394)." (Page 2) |
| Intended use aligns with predicate device. | "Both the new components and the existing system components are intended to address the same indications for use." (Page 2) The detailed Indications for Use for the extended system are provided on page 4, which are consistent with the predicate's purpose of spinal fusion in the cervical and occipitocervico-thoracic junction for conditions like Degenerative Disc Disease, Spondylolisthesis, etc. |
| Materials are equivalent to predicate device. | "Both the new components and the existing components are made from the same materials [Titanium alloy and CP Titanium]." (Page 2, and implied from predicate description on Page 1) |
| (Implicit) No new safety or effectiveness concerns are introduced. | The FDA’s determination of "substantial equivalence" (Page 2-3) indicates that the device meets the regulatory requirements and is as safe and effective as its predicate. |
Explanation: This 510(k) is for a line extension of an established spinal fixation system, not a device with a measurable performance output like an AI algorithm. The acceptance criteria are implicit: the new components must be mechanically equivalent to the predicate, made of the same materials, and address the same indications for use without raising new questions of safety or efficacy. The "study" proving this is a mechanical testing comparison.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission describes mechanical testing of components, not a clinical study on human subjects where a "test set" of data would be used. The "test set" would refer to the physical components tested in a lab, but the number is not specified.
- Data Provenance: Not applicable. The "data" comes from mechanical testing of manufactured components, not patient 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. There is no "ground truth" to be established by experts in the context of mechanical testing of a spinal implant. The "ground truth" is determined by established engineering standards and tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used for resolving disagreements in expert assessments of medical images or other clinical data, which is not relevant here.
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 not an AI-powered device and no reader studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Mechanical testing standards and engineering specifications. The "ground truth" for proving substantial equivalence lies in demonstrating that the mechanical properties of the new components match those of the predicate and that the materials are identical.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question does not apply.
Summary regarding the device:
This 510(k) document is a regulatory submission for a mechanical medical device (spinal implant components), specifically a line extension. It focuses on demonstrating substantial equivalence to a predicate device by showing that the new components have the same intended use, materials, and equivalent mechanical properties. The regulatory pathway is based on established engineering principles and material science, not on clinical performance metrics, AI algorithms, or human reader studies.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.