(582 days)
The Stryker Q Guidance System, with the Cranial Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery. The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system assists in the positioning of instruments for cranial procedures, including: Cranial biopsies Craniotomies Craniectomies Resection of tumors and other lesions Skull base procedures Transnasal neurosurgical procedures Transsphenoidal pituitary surgery Craniofacial procedures Skull reconstruction procedures Orbital cavity reconstruction procedures General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified.
The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient's facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures.
The Stryker EM Stylet is indicated for use as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: General ventricular catheter and shunt placement Pediatric ventricular catheter and shunt placement
The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Q Guidance System with Cranial Guidance Software is a computer-assisted stereotaxic, image-guided, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning instruments and locating patient anatomy during cranial surgery. The Q Guidance System with Cranial Guidance Software system is comprised of a computer platform. Cranial Guidance Software, navigated instruments (e.g., patient/ instrument trackers, pointers), and various system components. The system provides intraoperative guidance to the surgeon using electromagnetic, passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, electromagnetic field generator and box to plug in electromagnetic instruments, big touchscreen monitor, and a small touchscreen monitor. The Cranial Guidance Software is dedicated to cranial surgical procedures as defined in the indications for use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, pointers, suction tubes, seekers, etc. An instrument battery is required when a battery powered instrument or calibration device is used. The Cranial Guidance Software displays the intraoperative location of navigated surgical instruments relative to imported patient medical images via electromagnetic or wireless optical tracking technology. The software provides the functions to perform the indicated navigated cranial surgical procedures. The software guides the user through the necessary preoperative and intraoperative steps required to set-up and perform the navigated cranial surgical procedures. The Q Guidance System was initially cleared in premarket notification K220593. The only change to this device from its initial clearance is the addition of the electromagnetic tracking technology and the integration of the Zeiss Microscope using the Zeiss Microscope Tracker. The Cranial Guidance Software includes the following system components described below.
Here's a breakdown of the acceptance criteria and study information for the Stryker Q Guidance System with Cranial Guidance Software, EM Stylet, and Navigated Biopsy Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Design Goal) | Reported Device Performance (Mean and 99% CI Upper) |
|---|---|
| Optical Navigation Accuracy: | |
| Positional Displacement ≤ 2 mm | 1.45 mm (Mean), 2.65 mm (99% CI Upper) |
| Trajectory Angle Displacement ≤ 2° | 1.38° (Mean), 2.93° (99% CI Upper) |
| Electromagnetic Navigation Accuracy: | |
| Positional Displacement ≤ 2 mm | 1.19 mm (Mean), 2.57 mm (99% CI Upper) |
| Trajectory Angle Displacement ≤ 2° | 1.21° (Mean), 2.82 mm (99% CI Upper) |
| User Needs / Intended Use Met | All requirements met through cadaver labs or simulated use tests. |
| Safety Standards Met | All risk controls effective. No new issues of safety or effectiveness raised. |
| General Requirements & Performance Met | All design specifications met. No new issues of safety or effectiveness raised. |
| Software Verification & Validation Met | All requirements met. No new issues of safety or effectiveness raised. |
| Biocompatibility Met | Conformance to ISO 10993-1:2018 and FDA guidance. No new issues of safety or effectiveness raised. |
| Electrical Safety Met | Conformance to IEC 60601-1:2012 Reprint. |
| Electromagnetic Compatibility Met | Conformance to IEC 60601-1-2:2014, CISPR 11 Group 1, Class A, and RFID compatibility. |
| Shipping Functionality Maintained | Functionality maintained after simulated shipping. No new issues of safety or effectiveness raised. |
| Sterility Assurance Level (SAL) | 10⁻⁶ or greater for reusable devices (steam) and single-use devices (Ethylene Oxide). All requirements met. |
Important Note: The document explicitly states the system's design goal for accuracy is a mean of 2mm positional and 2° angular displacement. The reported performance includes a 99% Confidence Interval (Upper) which exceeds the 2mm/2° stated design goal in some instances (e.g., Optical Nav Positional Displacement 2.65mm, Optical Nav Trajectory Angle Displacement 2.93°, EM Nav Positional Displacement 2.57mm, EM Nav Trajectory Angle Displacement 2.82°). However, the document concludes that "All requirements were met and no new issues of safety or effectiveness were raised," implying these results were considered acceptable within the overall context of the safety and performance evaluation.
2. Sample Size Used for the Test Set and the Data Provenance
- Accuracy Testing:
- Pediatric patients: Non-clinical accuracy testing was performed using pediatric models made based on a neonate image set. The exact number of models is not specified.
- Adult patients: Accuracy testing was performed via a Simulated Use study with cadavers. The exact number of cadavers is not specified.
- Intended Use/User Needs Validation: Conducted in "cadaver labs or simulated use tests." The exact number of participants or cases is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the datasets used in testing (pediatric models, cadavers). The testing seems to be prospective (i.e., designed as part of the validation process) rather than retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth specifically for the accuracy testing of the device (i.e., for the positional and angular displacement measurements). The "Intended Use/User Needs" validation involved "intended users," but their specific number or qualifications (e.g., years of experience as surgeons) are not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the performance metrics. The accuracy measurements appear to be objective, engineering-style measurements against a known reference. For the "Intended Use/User Needs" validation, it simply states that all requirements were met, implying a qualitative assessment by the "intended users."
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. The 510(k) summary explicitly states: "No clinical testing was performed." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size on human reader improvement with AI assistance is reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The primary performance data reported (positional and angular displacement accuracy) are standalone algorithm/device accuracy metrics, as they quantify the device's ability to precisely locate structures and guide instruments in a controlled testing environment (using pediatric models and cadavers), independent of a human surgeon's subjective interpretation or decision-making beyond the act of using the device. This testing is focused on the device's intrinsic measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy measurements (positional and angular displacement), the ground truth would be based on precisely measured, known physical locations or trajectories within the test setup (pediatric models or cadavers). This is an engineering- or physics-based ground truth, where the "true" position or angle is established by highly accurate measurement systems or a known fiducial reference.
8. The sample size for the training set
The document does not provide any information about a training set size. This 510(k) summary describes a navigation system and its accessories, not a machine learning or AI algorithm that typically requires a separate training set. While the "Cranial Guidance Software" is mentioned, the performance evaluation focuses on the accuracy of the navigation system components rather than a pattern recognition or diagnostic AI.
9. How the ground truth for the training set was established
Since no information on a training set or its size is provided, the method for establishing its ground truth is also not described. As noted above, the device's evaluation is primarily based on the accuracy of its navigation capabilities, which rely on precise physical measurements rather than annotated data for training.
§ 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).