(200 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; and Tumors.
When used with the occipital plate the bone screws are limited to occipital fixation. 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 Spinal System via the rod to rod connector.
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. The components will be provided non-sterile.
The provided text describes a 510(k) premarket notification for the Stryker Spine Oasys System, a spinal fixation appliance. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, meaning they do not require a new scientific study demonstrating efficacy. Instead, substantial equivalence is often shown through similarities in intended use, materials, design, and mechanical testing that demonstrates comparable properties to the predicate device.
Therefore, the typical structure for reporting acceptance criteria and study results for AI/ML devices is not applicable here because this is a mechanical medical device, and the submission focuses on substantial equivalence rather than novel performance metrics.
Here's how to address the request based on the provided document:
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A table of acceptance criteria and the reported device performance:
- For a spinal fixation system, performance is typically assessed through mechanical testing against established standards and comparison to a predicate device, rather than diagnostic accuracy metrics like sensitivity or specificity.
- The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate device."
- Acceptance Criteria (Implied): The mechanical properties of the Stryker Spine Oasys System should be comparable to or meet the performance of the predicate device.
- Reported Device Performance: Mechanical testing demonstrated comparable mechanical properties to the predicate device.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This is not a data-driven study with a "test set" in the context of AI/ML. The "test set" here refers to the physical devices undergoing mechanical testing. The sample size for such testing would typically be determined by relevant ASTM or ISO standards for spinal implants, but this specific detail is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here would be the results from mechanical engineering tests.
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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. Ground truth in this context would be defined by engineering specifications and direct physical measurements during mechanical testing, often performed by engineers or technicians.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective human interpretations of data, such as image reviews. Mechanical testing results are objective measurements.
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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 physical medical device, not an AI/ML system, so MRMC studies involving human readers or AI assistance are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" would be established engineering standards (e.g., ISO, ASTM) and the direct physical properties and performance of the predicate device.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set" in the AI/ML sense.
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How the ground truth for the training set was established:
- Not applicable.
Summary based on the provided information for the Stryker Spine Oasys System:
This 510(k) submission for the Stryker Spine Oasys System does not involve an AI/ML device or a clinical study in the traditional sense of evaluating diagnostic performance. Instead, it demonstrates substantial equivalence to existing legally marketed devices based on shared intended use, materials, design, and comparable mechanical properties as shown through laboratory testing.
| Feature | Description for Stryker Spine Oasys System |
|---|---|
| Acceptance Criteria (Implied) | The mechanical properties of the Stryker Spine Oasys System components (rods, screws, hooks, connectors, occiput plate) must be comparable to the identified predicate device to demonstrate substantial equivalence. |
| Reported Device Performance | "Mechanical testing demonstrated comparable mechanical properties to the predicate device." (Specific values or comparative data are not provided in this summary but would have been part of the full 510(k) submission). |
| Sample Size (Test Set) | Not specified in the provided summary. This would typically refer to the number of physical components tested in mechanical experiments, determined by engineering standards. |
| Data Provenance (Test Set) | Not applicable in the context of clinical data. Testing would be performed in a laboratory setting. |
| Number & Qualifications of Experts (Ground Truth) | Not applicable in the context of clinical data. Engineers and technical staff would conduct mechanical testing against established engineering standards. |
| Adjudication Method (Test Set) | Not applicable; mechanical testing involves objective measurements rather than subjective interpretation requiring adjudication. |
| MRMC Comparative Effectiveness Study? | No. This is not an AI/ML device. |
| Standalone Performance Study (Algorithm Only)? | No. This is a physical medical device. |
| Type of Ground Truth Used | Established engineering standards (e.g., ASTM, ISO standards for spinal implants) and direct physical measurements/performance characteristics of the predicate device components during mechanical testing. |
| Sample Size (Training Set) | Not applicable. This is a physical medical device, not an AI/ML system. |
| How Ground Truth for Training Set was Established | Not applicable. There is no "training set" in the AI/ML context. The "training" for such a device involves product design and manufacturing processes adhering to quality systems and engineering specifications, often informed by performance data of existing (predicate) devices. |
§ 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.