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510(k) Data Aggregation
(78 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 (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 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 Xia® II and Xia® 3 System 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.
This document is a 510(k) Premarket Notification from the FDA to Stryker Corporation regarding their OASYS® System for spinal interlaminal fixation. It is a clearance letter and a 510(k) summary, not a study evaluating device performance against acceptance criteria in the way a diagnostic AI device or software might be assessed.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided text. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and engineering analysis, rather than clinical performance metrics.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "engineering analysis" to show that new longer length transition rods do not affect performance, but does not provide specific acceptance criteria or performance metrics for the OASYS system itself.
- Sample sized used for the test set and the data provenance: Not applicable. The "study" mentioned is an "engineering analysis," not a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this type of submission is typically based on pre-established engineering standards and comparisons to predicate devices, not on expert consensus from a clinical test set.
- Adjudication method: Not applicable.
- 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 spinal fixation device, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used: For this type of device, the "ground truth" for substantial equivalence is derived from established mechanical and material properties, and comparison to the predicate device's design and performance.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
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(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.
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(113 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 (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 of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xia® 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 Xia® II and Xia® 3 System 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 provided text describes a 510(k) premarket notification for the Stryker Spine OASYS® System, a spinal interlaminal fixation orthosis. The submission is for a modification to an already legally marketed predicate device (Stryker Spine OASYS® System: K111719) and therefore does not include a comprehensive study on a new AI device or a detailed acceptance criteria table with reported device performance metrics in the way one might expect for a new diagnostic device.
Instead, the submission focuses on demonstrating that a modification to an existing device (the addition of screws with a modified drive mechanism) does not negatively affect the device's performance compared to the predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a table of reported device performance values against those criteria, as it's a 510(k) for a modification to an existing device rather than a de novo submission for a novel device or AI diagnostic.
However, the "Summary of Performance Data" section implies the acceptance criteria for this specific modification:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Addition of screws with modified drive mechanism does not affect the performance of the OASYS® System. | "An engineering analysis was performed to demonstrate that the addition of screws with a modified drive mechanism does not affect the performance of the OASYS® System." |
2. Sample Size for Test Set and Data Provenance
The document states an "engineering analysis was performed." This is typically a mechanical test, not a clinical study involving a "test set" of patients or data in the way an AI diagnostic would require. Therefore, there's no information on a patient-based sample size or data provenance (country of origin, retrospective/prospective). The "test set" would likely refer to the physical screws and system components used in the engineering analysis.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic outcome. The "ground truth" here would be the physical integrity and mechanical performance of the modified screws and system components, assessed through engineering principles and testing.
4. Adjudication Method
Not applicable, as this is an engineering analysis, not a study involving expert readers and diagnostic assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not conducted. This is not an AI device, and no human-in-the-loop performance or comparison to human readers is described.
6. Standalone Performance
Not applicable. This is not an AI algorithm but a physical medical device. The "engineering analysis" would represent the standalone evaluation of the modified components' mechanical performance.
7. Type of Ground Truth Used
The ground truth used is based on engineering and mechanical testing standards and performance benchmarks, comparing the modified components to the previously cleared predicate device. This would involve stress tests, fatigue tests, and other mechanical property assessments to ensure the new square drive mechanism does not compromise the device's integrity or function.
8. Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How Ground Truth for the Training Set was Established
Not applicable.
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