(126 days)
The Stryker Navigation System, with the CranialMap software application, 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 reference to a rigid anatomical structure can be identified.
The system should be operated only by trained personnel such as surgeons and clinic staff.
The system assists in the positioning of instruments for cranial procedures, including:
- Cranial bionsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs.
The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computer-assisted surgery.
The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate.
The software application should be operated only by trained personnel such as surgeons and clinic staff.
This can include the following cranial procedures:
- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient's face on top of the skin.
- In combination with preoperative and intraoperative imaging devices, it enables 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 procedures.
The devices subject to this Traditional 510(k) are within the Stryker Navigation System with CranialMap software application. Subject devices include the CranialMap software application, CranialMap Planning software application, and CranialMask Tracker.
The Stryker Navigation System with CranialMap 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 precise positioning of instrumentation during Cranial surgeries. The system provides intraoperative guidance to the surgeon by displaying the position of navigated surgical instruments relative to the medical images.
The Stryker Navigation System with CranialMap software is comprised of a platform, CranialMap software application, navigated instruments, and accessories. The predicate CranialMap Neuro navigation system includes the same parts. The platform consists of a computer, camera, and IO-Tablet (input/output). The CranialMap software is dedicated for the Cranial procedures as defined in the indications for use and identical to the predicate. Required navigated instruments include: a patient tracker; a pointer, suction tube, or seeker; shunt placement tool, and a frameless guide. A battery is the only required accessory of the system, and is used in the navigated instruments only.
The CranialMap software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The CranialMap software is used with a Stryker platform and interfaces with Stryker navigated instruments and accessories. The software displays the intraoperative location of navigated surgical instruments relative to imported medical images via wireless optical tracking technology. The subject CranialMap software does not provide direct or indirect patient-contact.
CranialMap is an interactive software application, which provides the functions needed to conduct the indicated cranial procedures. The software application implements the methods for planning, patient registration, and instrument navigation. Furthermore, the software guides the user through preoperative and intraoperative workflow steps. The significant changes made to the subject CranialMap software when compared with the predicate include adding planes and mirroring functionalities and adding compatibility with the CranialMask Tracker.
The CranialMap Planning software is an optional accessory to the Stryker Navigation System with CranialMap software application. The CranialMap Planning software application is a standalone software device intended for use on compliant computers as defined in the Safety Information document. It is a new device introduced with this Traditional 510(k).
The subject CranialMap Planning software application is an identical subset of functionality copied from the subject CranialMap software. The planning version serves to preoperatively plan a navigated surgery, outside of the operating room, on a compliant computer. It does not provide registration functionality or surgical navigation guidance, and it does not interface with instruments or accessories. The preplanned patient record can only be exported to the Stryker Navigation System with CranialMap software. The subject CranialMap Planning software does not provide direct or indirect patient-contact.
The CranialMask Tracker is a non-invasive patient tracker. It is indicated as an optional accessory to the Stryker Navigation System with CranialMap software application. The subject CranialMask Tracker directly contacts the patient skin, which is identical to the predicate Patient Registration Mask.
The CranialMask Tracker includes a flexible printed circuit board (PCB) mask and closed housing unit. It consists of tracking diodes, green status light emitting diode (LED), communication receiver, battery, an on/off switch, and adhesive backing. The electronic components in the communication unit of the CranialMask Tracker are identical to the components used in the reference device, SpineMask Tracker, cleared by K141941.
This Traditional 510(k) requests clearance for changes made to the CranialMap software used with the Stryker Navigation System. It also seeks clearance for the new CranialMap Planning software and CranialMask Tracker devices as optional accessories to the system.
The provided document is a 510(k) summary for the Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning Software Application, and Stryker CranialMask Tracker. It details the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.
Here's the breakdown of acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the system's accuracy as a key performance metric.
| Acceptance Criterion | Reported Device Performance (Mean) | Reported Device Performance (99th Percentile) |
|---|---|---|
| Positional displacement accuracy ≤ 2mm | 1.11 mm | 2.85 mm |
| Trajectory angle displacement accuracy ≤ 2° | 1.02° | 2.56° |
Note: While the document states the system has a "mean navigation accuracy of ±2mm and angular axis displacement of ±2°," the reported performance data shows that the 99th percentile for both positional and trajectory angle displacement exceeds the 2mm/2° threshold. This discrepancy might imply that the acceptance criterion was intended for the mean accuracy, or it could be an area that would typically lead to further questions from the FDA if not adequately addressed. However, for the purpose of this response, we are reporting the information as presented.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the accuracy test set (e.g., number of measurements or cases). It only provides the mean, standard deviation, and 99th percentile of positional and trajectory angle displacement.
Regarding data provenance: The document does not specify the country of origin for the data. The study was conducted as a "Nonclinical verification and validation testing," implying it was an internal test, not a retrospective or prospective human clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for the system accuracy was established through physical measurements and calculations, not human expert consensus, as this is a navigation system.
4. Adjudication Method for the Test Set
Not applicable. This was a technical accuracy study, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was deemed not required to support the safety and effectiveness of the subject devices for the intended use." The studies conducted were non-clinical verification and validation tests focused on technical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the performance data provided (positional and trajectory angle displacement) refers to the system accuracy, which represents the algorithm's (and integrated hardware's) standalone performance in guiding instruments relative to images. While the device is intended for human use, these accuracy metrics reflect the fundamental technical capability of the system itself, independent of a specific human user's performance.
7. Type of Ground Truth Used
The ground truth used was physical measurements and calculations related to the spatial accuracy of the navigation system. This is a technical ground truth rather than a clinical ground truth like pathology, outcomes data, or expert consensus. For example, measurements involving known reference points or phantom models would be used to objectively determine displacement and angular errors.
8. Sample Size for the Training Set
The document does not specify a training set size. This is likely because the device is a computer-assisted surgical navigation system and planning software, not an AI/ML model that typically undergoes explicit "training" on a dataset in the same way a diagnostic image analysis algorithm would. The development likely involved software engineering, calibration, and verification rather than machine learning model training on a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, the concept of a "training set" and associated "ground truth establishment" derived from data points, as would be relevant for an AI/ML diagnostic algorithm, does not directly apply to this type of medical device which is a navigation system. Its development involves software and hardware engineering, calibration, and rigorous verification and validation against defined performance specifications.
§ 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).