(262 days)
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA, and ultrasound) of the anatomy, such as:
- Cranial Resection
- Resection of tumors and other lesions
- Resection of skull-base tumor or other lesions
- Intracranial catheter placement
The Subject Device, Cranial EM System, consists of software and hardware components. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. The tracking data are acquired via electromagnetic tracking. Cranial EM is a touchscreen-based intraoperative navigation software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as MR and/or CT, can support the surgeon during various surgical interventions. Cranial EM uses scanned images of the patient that are acquired before surgery is performed.
The following software make up the main module of the device:
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- EM Setup 2.1
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- Head Registration 2.1
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- EM Instruments 2.1
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- Navigation 2.1
The Subject Device Consists of the following hardware components:
Platforms:
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- Kick 2 Navigation Station (Article Number: 18202)
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- Curve Navigation 17700 (Article Number: 17700)
Instruments:
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- EM Patient Reference 2.0 (18099-24)
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- EM Pointer (18099-02C)
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- EM Instrument Reference (18099-05A)
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- EM Registration Pointer (18099-23)
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- EM Stylet 2.0 (18097-01)
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- EM Short Pointer (18099-27)
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- EM Skull Reference Base (18099-06)
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Cranial EM System) |
|---|---|
| Mean location error | ≤ 2 mm |
| Mean trajectory angle error | ≤ 2 degrees |
2. Sample Size and Data Provenance for Test Set:
The provided document does not specify a distinct sample size for a test set in terms of patient data or case studies. Instead, it mentions "System accuracy tests (Software + platforms + instruments)" were conducted. The data provenance is not explicitly stated as country of origin, nor whether it was retrospective or prospective patient data. The accuracy tests described appear to be laboratory performance evaluations of the device's hardware and software components rather than clinical trials with patient data.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable. The ground truth for the core accuracy metrics (mean location error and mean trajectory angle error) was established through technical measurements of the system's performance, not through expert consensus on clinical cases.
4. Adjudication Method for Test Set:
Not applicable. Since the ground truth was established through technical measurements (System accuracy tests), an adjudication method for a test set involving human interpretation is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document states, "No clinical testing submitted for the Subject Device. Data from existing literature was leveraged for validating the Subject Device's indications." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human readers' improvement with AI assistance is provided for this submission.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The "System accuracy tests (Software + platforms + instruments)" directly assess the algorithm's performance (in conjunction with its hardware) without a human-in-the-loop. The reported performance metrics (mean location error ≤ 2 mm, mean trajectory angle error ≤ 2 degrees) are results of this standalone testing.
7. Type of Ground Truth Used:
The type of ground truth used for the device's core accuracy metrics (mean location error and mean trajectory angle error) was technical measurement and engineering specifications. This is established by rigorous performance testing of the device hardware and software against known physical standards.
8. Sample Size for the Training Set:
The document does not provide information regarding a specific "training set" for an AI algorithm in the context of device accuracy. The "System accuracy tests" were likely performance validation tests rather than training data for an adaptive algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable. Information regarding a training set and its ground truth establishment is not provided in the document. The device's validation appears to rely on established engineering principles and performance testing against predefined accuracy standards, rather than machine learning models requiring extensive training data.
§ 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).