(164 days)
The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient mage data being processed by the navigation. The system 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
The Microscope Navigation Software (also referred to as subject device or Microscope App) is a software. It runs on a Brainlab navigation system consisting of a computer, a display and an IR tracking camera (referred to as platform) and a Brainlab Image Guided Surgery software (referred to as IGS software).
The Microscope Navigation encapsulates microscope specific functionality and separates it from the IGS software.
The device interfaces with the IGS software and e.g. utilizes the registration provided by the IGS software.
The device assists surgeries where a surgical microscope is used. It provides information based on the field of view through the microscope, the microscope position relative to the patient and the medical imaging data of the patient.
The subject device provides functionality to verify and correct a patient registration. The Microscope Navigation does not provide its own registration.
Here is a detailed breakdown of the acceptance criteria and study information for the "Microscope Navigation Software":
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microscope Focus Point Accuracy: | |
| Accuracy of the focus point in the focal plane | The accuracy of the focus point in the focal plane is 1.2 mm +/- 0.5 mm (99th percentile 2.4 mm). |
| Three-dimensional error including focus point distance | The three-dimensional error including the distance of the focus point is measured to 1.9 mm +/- 1.0 mm (99th percentile 4.6 mm). |
| Navigation Update: | |
| Accuracy improvement for registration errors | The Navigation Update can improve registration errors. For translations and rotations parallel to the focus plane, the Navigation Update is accurate up to 0.8 mm +/- 0.3 mm (99th percentile 1.4 mm). |
| Sufficient ground accuracy | The ground accuracy provided by the subject device is sufficient to assess navigation accuracy repeatedly throughout a procedure and identify deviations (implies that the measured performance meets the functional requirements for clinical use). |
| Usability | All usability tests were rated as successfully passed according to their acceptance criteria, ensuring that the user interface can be used safely and effectively. (Specific quantitative criteria for usability are not provided in this document, only that they were met.) |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The tests were performed "on a phantom."
- Data Provenance: The studies were non-clinical, utilizing phantoms. The origin of the phantom or simulated data is not specified beyond being "non-clinical data according to Brainlab procedures."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established through physical measurements on a phantom, not by expert consensus on clinical cases.
- Qualifications of Experts: Not applicable.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. The "ground truth" was established through direct measurement against a known physical standard (phantom landmarks) using the IGS system, not through human interpretation requiring adjudication.
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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 performed or reported. This device is a navigation software for surgical microscopes and does not involve "human readers" in the sense of interpreting medical images like an AI diagnostic tool would. It assists surgeons during procedures.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the verification tests described for "Microscope focus point accuracy" and "Navigation Update" are standalone performance tests of the algorithm/device's accuracy on a phantom. The "Microscope Navigation Software" (the subject device) is a software module that runs on a Brainlab navigation system and operates objectively to determine accuracy in these tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the verification tests was established through physical measurements on a phantom with known landmarks and dimensions, as measured by the existing IGS System or external measurement tools.
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The sample size for the training set:
- The document does not provide a sample size for a training set. This is not an AI/ML-based diagnostic device that typically requires a large training dataset for model development. It's a software for image-guided navigation based on established principles of tracking and image registration.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML model is mentioned. The device's functionality is based on known physical principles and software algorithms, not trained on a dataset in the manner of machine learning.
§ 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).