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510(k) Data Aggregation
(152 days)
NavSuite3 Kit
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The Computer Monitor displays the navigation information to the user.
The NavSuite®3 Kit is a minor modification of the previously cleared Stryker NAV3i Platform. The NavSuite®3 Kit consists of the same main components that were cleared as the NAV3i Platform in K130874. The NAV3i Platform (K130874) consisted of a mobile cart, a computer system, a monitor, an IO Tablet and a navigation camera. The subject of this Special 510(k) is that the system is now modified to provide these same components, without the mobile cart and without the monitor. The computer, IO Tablet and navigation camera are now provided as separate components that can be configured and affixed in the operation room suite based on user preferences. The monitor that was provided with the NAV3i Platform is not provided with the NavSuite®3 Kit. The NavSuite®3 Kit is compatible with any monitor that meets the specifications provided in the Instructions for Use.
Like the predicate Nav3i platform, the NavSuite3 Kit platform is compatible with the following previously cleared Stryker Software Application Modules:
The provided text describes a 510(k) premarket notification for the Stryker NavSuite®3 Kit, which is a computer workstation used with navigation software for cranial and orthopedic spinal surgical procedures. The notification asserts substantial equivalence to a predicate device (Stryker NAV3i Platform K130874), focusing on minor modifications to the physical components rather than the core navigation algorithms.
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review, the NavSuite®3 Kit, is a modified version of a previously cleared device (NAV3i Platform, K130874). The modifications primarily involve the physical components (e.g., removing the mobile cart and monitor, changing camera mounting and cabling, removing the UPS and LiveCAM). The core navigation software and its functionalities (CranialMap Neuro Navigation and SpineMap 3D Navigation) are stated to be compatible and previously cleared.
Therefore, the "acceptance criteria" here are not about specific performance metrics for a novel algorithm's accuracy, sensitivity, or specificity, but rather about demonstrating that the physical modifications do not introduce new risks or alter the fundamental scientific technology or intended use, and therefore the device remains as safe and effective as the predicate.
The acceptance criteria implicitly derive from ensuring that the modified components function as intended and do not compromise the safety or performance of the integrated system.
| Acceptance Criteria (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| No new risks introduced by modifications. | A functional risk analysis was conducted according to ISO 14971, 2nd Edition (2007). The results determined that the device modifications do not introduce any new risks compared to the predicate device. All existing risks were identified and mitigated to a level "as low as reasonably possible." The effectiveness of these mitigation measures was verified by the detailed testing. |
| Power Supply (Removal of UPS): System stability and behavior during power events must not be compromised. | System Test: Shutdown and crash behavior was tested with the Navigation Software Application Modules integration tests to ensure stability without the UPS. The justification for removing the UPS is that the subject device is a fixed installation and not intended to be mobile, hence the UPS is not needed. |
| Operating System (Minor configuration changes): OS must remain effective and compatible with navigation software. | Component Test: Showed that configurations were implemented and effective. |
| System Test: Showed that fixed resolution was used on several monitors, verifying compatibility and functionality. | |
| Monitor (No longer provided, user-supplied compatible monitor): Display quality and compatibility maintained. | System Test: Various compatible monitors (meeting 1920x1080 pixels native resolution, DVI signal) were tested with Native Resolution and with the Navigation Software Application Modules integration tests, confirming proper display and functionality. The instructions for use specify the required monitor specifications, which are the same as the predicate device's monitor. |
| Navigation Camera Mounting (Ceiling-mounted arm): Robustness, reliability, and range of motion must be maintained. | System Test: Automated mechanical stress tests were performed to demonstrate reliability through simulated intraoperative use over the device's lifetime. This included rotational and vertical adjustment capabilities and ensuring the camera joint could move without restrictions within its range of motion. Statistical methods were used. A lifetime of 1000 movement cycles was estimated for a camera joint. Tests were conducted on five test samples, each over 5687 test cycles, exceeding the estimated lifetime. |
| Navigation Camera Cables (Optical fibers, extended length): Data transfer and power supply must be reliable. | Component Test: Verified voltage and data transfer for the new optical fiber cables. |
| System Tests: Automated mechanical stress tests demonstrated the reliability of the Navigation camera cables (power and data) through simulated intraoperative use over their specified lifetime using statistical methods. A lifetime of 1000 movement cycles was estimated for a camera cable set. Tests were conducted on five test samples of camera cable sets, each over 5687 test cycles, exceeding the estimated lifetime. | |
| LiveCAM (Not provided): Absence must not affect navigation software functionality. | System Test: Verified that the applicable Software Application Module (CranialMap Neuro Navigation, SpineMap 3D Navigation) was not affected by the absence of LiveCAM. This was tested with Navigation Software Application Module integration tests. The LiveCAM was an optional component in the predicate and not required for optimal system performance. |
| Cart with Castors (Not provided): The absence of mobility must align with the intended fixed installation. | No testing was required for the absence of the cart. The justification is that the NavSuite®3 Kit components are intended for fixed installation in the OR and not for mobility, differentiating it from the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the mechanical stress tests on the camera mounting and cables, five test samples of camera joints and five test samples of camera cable sets were used. Each of these samples underwent 5687 test cycles. For other system and component tests (UPS, OS, Monitor, LiveCAM), the documentation refers to "integration tests" or "various compatible monitors," implying testing across the system's operational parameters rather than a specific number of unique cases or patients.
- Data Provenance: Not explicitly stated for all tests. For the hardware component and system tests, it is reasonable to assume these were conducted in a laboratory or engineering testing environment by the manufacturer (Stryker Leibinger GmbH & Co. KG in Germany). The studies are primarily engineering validation tests for hardware modifications, not clinical efficacy studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is not applicable to the performance data presented. The studies described are engineering and functional tests to confirm the hardware modifications do not negatively impact the system's performance or safety from an engineering perspective. They do not involve clinical diagnosis or interpretation of medical images where expert consensus would establish ground truth for algorithm performance.
4. Adjudication Method for the Test Set
This is not applicable as the studies are engineering validation tests for hardware components, not clinical studies requiring adjudication of diagnostic outcomes.
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
No MRMC comparative effectiveness study was done or is mentioned. The submission is for hardware modifications to an existing navigation system, not for a novel diagnostic AI algorithm that would typically undergo such a study. The "AI" component (the navigation software) was previously cleared.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "algorithm only" performance (i.e., the navigation software's accuracy in tracking instruments and displaying images) was implicitly addressed during the prior 510(k) clearances for the CranialMap Neuro Navigation (K131214) and SpineMap 3D Navigation (K141941) software modules and the predicate NAV3i Platform (K130874). This current submission is not focused on re-evaluating the standalone performance of the navigation algorithms themselves, but rather on demonstrating that the new hardware configuration does not degrade that previously established performance.
7. The Type of Ground Truth Used
For the engineering tests conducted:
- For the robustness and lifetime tests of the camera arm and cables, the "ground truth" was the expected physical durability and functionality of the components under simulated stress, often defined by engineering specifications and industry standards.
- For the system integration tests (UPS, OS, Monitor, LiveCAM), the "ground truth" was the expected functional behavior and compatibility with the existing navigation software, verified against predefined system requirements and successful operation of the software.
8. The Sample Size for the Training Set
Not applicable. This submission is for hardware modifications and engineering validation. There is no mention of a "training set" in the context of machine learning or AI algorithm development for this specific 510(k). The navigation software itself would have had its own development and validation processes, but that is not the subject of this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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