(182 days)
The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical 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 NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.
The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k).
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 NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.
The Stryker NAV3i Platform is a computer workstation intended to display patient-specific images/anatomical landmark information and track surgical instruments for stereotactic procedures when used with specific Stryker Navigation surgical software. The non-clinical testing conducted aimed to demonstrate that the device performs as safely and effectively as its predicate device, the Cart I Platform (Stryker Navigation System - ENT Module, K002732).
Here's an analysis of the acceptance criteria and study details provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| User Need Validation | All user needs for the NAV3i Platform under simulated use case situations are met, and the Indications For Use are validated. | Validation successful, all user needs met. |
| Human Factors Engineering (HFE) | Device is safe and effective with respect to use errors. | Validation successful, device safe and effective with respect to use errors. |
| Safety Test regarding risk analysis | All risk control measures specified in the NAV3i Platform risk analysis are effective and mitigate associated risks. | Risk Control measures are effective and mitigate the associated risks. |
| Product Safety Test regarding medical electrical equipment | Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 standards for medical electrical equipment (Part 1 & Part 1-2). | Compliance with standards' requirements demonstrated, no deviations. |
| Accuracy Test | All accuracy specifications are met. | All accuracy specifications met with statistical significance. (Following ASTM F2554-10) |
| Integration Tests with Stryker Navigation Software Applications | All specified Stryker Navigation Software Application Modules (SpineMap 3D, OrthoMap 3D, Versatile Hip, Express Knee, Precision Knee, Fluoro, FluoroMap, CranialMap) meet specifications on the NAV3i Platform, demonstrating compatibility. | All Application Modules meet specifications on NAV3i Platform as on previous platforms. (Tested under simulated clinical use conditions) |
| Startup Reliability | Device is electronically reliable over its specified lifetime, including Stryker Navigation Software Application Modules across multiple usages. | Device electronically reliable over the specified lifetime. (Number of test samples and runs determined using statistical methods) |
| Robustness for everyday use | Device is mechanically robust over its specified lifetime, considering transport inside hospital and intraoperative use. | Device mechanically robust over the specified lifetime. (Number of test samples and runs determined using statistical methods, simulating hospital transport and intraoperative use) |
| Shipment Test | Device is fully functional after shipment. | Device fully functional after shipment. (Performed according to ASTM D 4169-09 for transport conditions in transport cases) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing for a medical device platform. Rather than a test set of patient data, the studies involved various engineering and simulated use tests.
- Accuracy Test: While the document states "All accuracy specifications met with statistical significance," it does not specify the sample size for the accuracy test. It mentions following ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, which would define the methodology for determining accuracy.
- Startup Reliability & Robustness: The document states that "The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods." However, specific sample sizes (number of devices, number of runs) are not provided.
- Data Provenance: The studies are non-clinical, involving device testing rather than patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the traditional sense. These would be considered prospective laboratory/engineering tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since these are non-clinical engineering and usability tests, the concept of "ground truth established by experts" in the clinical imaging sense is not directly applicable.
- User Need Validation and Human Factors Engineering (HFE) would involve user feedback and expert assessment (e.g., human factors engineers, clinical users like surgeons) to validate usability and user needs. However, the number and specific qualifications of any experts involved are not detailed in the summary. It broadly states "Validation successful, all user needs met" and "Validation successful, device safe and effective with respect to use errors."
4. Adjudication Method for the Test Set
Not applicable. The described tests are primarily performance and safety evaluations of the device's technological characteristics, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done.
- The document explicitly states: "No clinical testing has been conducted."
- This submission focuses on establishing substantial equivalence for a platform based on its technological characteristics and non-clinical performance, not on the clinical effectiveness of specific surgical software or human-AI interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described is primarily standalone device performance (without a human-in-the-loop clinical effectiveness study).
The "Accuracy Test" evaluates the Stryker Navigation System's (including NAV3i Platform, software, instruments) positional accuracy directly, without human interpretation as part of the primary measurement.
"Integration Tests" confirm compatibility and performance of the platform with various software modules in a simulated clinical use, essentially evaluating the combined system's functional integrity.
7. The Type of Ground Truth Used
For the non-clinical tests:
- User Need Validation: Ground truth would be defined by the pre-established user requirements and intended uses of the device.
- Human Factors Engineering: Ground truth relates to established human factors principles and identified potential use errors.
- Safety Test regarding risk analysis: Ground truth is based on the identified risks and the defined effectiveness of risk mitigation measures.
- Product Safety Test regarding medical electrical equipment: Ground truth is the compliance with specific international standards (AAMI/ANSI ES60601-1).
- Accuracy Test: Ground truth for accuracy would be an objectively measured "true" positional reference, as defined by the ASTM F2554-10 standard. This standard outlines methods to measure positional accuracy, typically involving phantoms and known spatial references.
- Integration Tests, Startup Reliability, Robustness, Shipment Test: Ground truth is the device meeting its predefined engineering specifications and functional requirements under various conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware platform for surgical navigation software. The document does not describe any machine learning or AI algorithms requiring a training set in the context of device clearance. The software that runs on the platform is cleared separately.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for machine learning/AI algorithms in this submission for the NAV3i Platform.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).