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

Device Description

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.

AI/ML Overview

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

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."
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.
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.
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.
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.
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.
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.
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.

Summary

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March 1, 2018

Brainlab AG Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Straße 9 81829 Munich, Germany

Re: K172820

Trade/Device Name: Microscope Navigation Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 30, 2018 Received: February 2, 2018

Dear Alexander Schwiersch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

for

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172820

Device Name Microscope Navigation Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY MICROSCOPE NAVIGATION 1.0

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

Manufacturer:	Brainlab AGOlof-Palme-Straße 981829 MunichGermany
Submitter:	Oliver Fleig
Contact person:	Alexander Schwiersch
Summary date	June 20, 2017
Device	Microscope Navigation
Trade name	Microscope Navigation Software
Common name:	Frameless Stereotaxic Navigation System
Classification name:	Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW)
Predicate Device:	K082060 VECTORVISION CRANIAL
Regulatory Class:	Class II
Regulation Number:	882.4560
Intended use:	The Brainlab Navigation System - Microscope Navigation Software is a softwaremodule, that when used with a Brainlab navigation system and compatible instrumentaccessories, is intended as image guided planning and navigation system to enableopen and minimally invasive surgery.It links an instrument and the view of the surgical field (e.g. video, view through surgicalmicroscope) to a virtual computer image space on patient image data being processedby the navigation workstation. The system is indicated for any medical condition inwhich a reference to a rigid anatomical structure can be identified relative to images(CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy

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Device description:	The Microscope Navigation Software (also referred to as subject device or MicroscopeApp) is a software. It runs on a Brainlab navigation system consisting of a computer, adisplay and an IR tracking camera (referred to as platform) and a Brainlab ImageGuided Surgery software (referred to as IGS software).The Microscope Navigation encapsulates microscope specific functionality andseparates it from the IGS software.The device interfaces with the IGS software and e.g. utilizes the registration providedby the IGS software.
The device assists surgeries where a surgical microscope is used. It providesinformation based on the field of view through the microscope, the microscope positionrelative 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.
Reason for 510(k)submission:	New device.

Device description:

The device assists surgeries where a surgical microscope is used. It providesinformation based on the field of view through the microscope, the microscope positionrelative 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.

Reason for 510(k)submission:

New device.

Substantial Microscope Navigation has been verified and validated using non-clinical data equivalence: according to Brainlab procedures for product design and development. The information provided by Brainlab in this 510(k) application supports the claim of substantial equivalence to the predicate device VectorVision Cranial.

Microscope Navigation separates microscope specific functionality in an separate application. Microscope specific views are bundled in this application.

Comparison of Subject Device and Predicate Device

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	Predicate DeviceVectorVision Cranial K082060	Subject DeviceMicroscope Navigation
Intended Use	The Brainlab Cranial IGS System isintended to be an intra-operative imageguided localization system to enableminimally invasive surgery. It links afreehand probe, tracked by a magneticsensor system or a passive marker sensorsystem to a virtual computer image spaceon patient image data being processed bythe navigation workstation.The system is indicated for any medicalcondition in which the use of stereotacticsurgery may be appropriate and where areference to a rigid anatomical structure,such as the skull, a long bone, or vertebra,can be identified relative to a CT, CTA, X-Ray, MR, MRA and ultrasound basedmodel of the anatomy.Example procedures include but are notlimited to:Cranial Procedures:Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies	The Brainlab Navigation System -Microscope Navigation Software is asoftware module, that when used with acompatible computer and compatibleinstrument accessories, is intended as imageguided planning and navigation system toenable open and minimally invasive surgery.It links an instrument and the view of thesurgical field (e.g. video, view throughsurgical microscope) to a virtual computerimage space on patient image data beingprocessed by the computer. The system isindicated for any medical condition in which areference to a rigid anatomical structure canbe identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of theanatomy
BrainlabPlatform	Brainlab KolibriBrainlab VectorVision	Brainlab KickBrainlab Curve
OperatingSystem	Windows XP	Windows 7Windows 8.1
Application(Use)	Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies	Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/Craniectomies
GUI	Microscope functionality integrated in thepredicated device software	Microscope separated from predicateddevice. Microscope specific views
Trackingtechnology	passive, reflective markers	passive, reflective markers
	Predicate DeviceVectorVision Cranial K082060	Subject DeviceMicroscope Navigation
Changes toPredicateDevice:		Microscope Navigation separates microscopespecific functionality from the predicatedevice.Microscope Navigation adds a functionality toadjust small deviations in patient to data setregistration (referred to as RegistrationUpdate or Navigation Update in the technicalfile). The adjustment is based on thediscrepancy between data to patient overlay

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Verification summary:

Test	Test Method Summary	Results
Microscope focuspoint accuracy	The focal point crosshair is aligned to alandmark on a phantom for differentworking distances. The distancebetween landmark and focus pointmeasured by the IGS System.	The accuracy of the focus point in the focalplane is 1.2 mm +/- 0.5 mm (99th percentile2.4 mm).The three-dimensional error including thedistance of the focus point is measured to1.9 mm +/- 1.0 mm (99th percentile 4.6 mm).
NavigationUpdate	The Navigation Update is performed ona phantom for different initial registrationaccuracies. The accuracy of the initialaccuracy is compared to the accuracyafter an update on landmarks on thephantom.	The Navigation Update can improveregistration errors.For translations and rotations parallel to thefocus plane the Navigation Update is accurateup to 0.8 mm +/- 0.3 mm (99th percentile1.4 mm).

The subject device is part of a set of application of an IGS system. The errors above are measured under a OR setup conditions with optimal paired-point registrations. The ground accuracy provided by the subject device is sufficient to assess navigation accuracy repeatedly throughout a procedure and identify deviations.

The subject device uses identical calibration methods. The tracking method and algorithms are identical. Instrument design and marker geometry is unchanged. The subject device is substantial equivalent to its predecessor.

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Validation summary:

The validation comprises usability tests which to ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. The non-clinical validation has been performed with software and equipment that are identical or equivalent to the final version of the product.

Regulation Number and Section

§ 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).