Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/ CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

Device Description

The Subject Device is intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

In a spinal context, Automatic Registration serves as accessory to the Spine & Trauma navigation system.

The Matrices are reusable devices delivered in non-sterile condition. The devices makes the Correlation ("Registration") of Intraoperative acquired patient data to the surgical environment possible by determining its position in relation to the patient and the navigated instruments.

AI/ML Overview

The document describes K203679, a premarket notification for the "Automatic Registration" device by Brainlab AG. The device is a surgical device for image-guided surgery intended to be used in combination with compatible Brainlab navigation systems, providing image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.

Here's an analysis of the acceptance criteria and study data provided:

Acceptance Criteria and Device Performance

Acceptance Criteria (Predicate Device)	Reported Device Performance
Mean navigation accuracy: <= 2.0mm	Mean navigation accuracy: 0.93mm
95th percentile of single navigation accuracy: <= 3.0mm	95th percentile of single navigation accuracy: 1.80mm

Note: The study for the subject device (Automatic Registration) used stricter acceptance criteria for its own evaluation (mean navigation accuracy: <= 1.5mm, 95th percentile of single navigation accuracy: <= 2.5mm) and successfully met them, demonstrating better performance than the predicate device. The table above compares its performance against the predicate's acceptance criteria to show superiority.

Study Details

Sample sizes used for the test set and data provenance:
- Test set sample size:
  - Total number of navigation points: n = 228
  - Total number of scans used: m = 50
- Data provenance: "simulated test environment"
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not specified. The document indicates a "simulated test environment" and accuracy measurements, but does not mention human experts establishing ground truth for the test.
Adjudication method for the test set:
- Not applicable as the ground truth was established by direct measurement in a simulated environment, not by human review and adjudication.
Multi Reader Multi Case (MRMC) comparative effectiveness study:
- No MRMC comparative effectiveness study was done. The study focuses purely on the device's accuracy in a standalone/simulated setting, not on its impact on human reader performance.
Standalone performance:
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The data presented reflects the "Automatic Registration" device's accuracy in a simulated environment.
Type of ground truth used:
- The ground truth was established through direct measurement of navigation accuracy in a "simulated test environment." This implies a precisely controlled and measurable setup where the true position is known.
Sample size for the training set:
- Not specified. The document only mentions the test set used for performance evaluation.
How the ground truth for the training set was established:
- Not specified, as the training set details are not provided.

Summary

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March 18, 2021

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Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bavaria 81829 Germany

Re: K203679

Trade/Device Name: Automatic Registration Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 12, 2021 Received: February 16, 2021

Dear Chiara Cunico:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203679

Device Name Automatic Registration

Indications for Use (Describe)

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

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510(k) Summary

March 17, 2021

General Information
Manufacturer	Brainlab AG
Establishment Registration	8043933
Device Name	Orthopedic Stereotaxic Instrument
Trade Name	Automatic Registration
Classification Name	Stereotaxic instrument
Product Code	OLO
Regulation Number	882.4560
Regulatory Class	II
Panel	Orthopedic
Predicate Device and K Number	Spine & Trauma Navigation System - K183605
Manufacturer	Brainlab AG

Contact Information
Primary Contact	Alternate Contact
Chiara Cunico	Regulatory Affairs Brainlab
Manager RA	Phone: +49 89 99 15 68 0
Phone: +49 89 99 15 68 0	Fax: +49 89 99 15 68 5033
Email: chiara.cunico@brainlab.com	Email: regulatory.affairs@brainlab.com

1. Indications for Use

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

2. Device Description

K203679 510(k) Summary

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Image /page/4/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The logo and the word are both in black and the background is white.

Automatic Registration is a surgical device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images. It consists of the software module Automatic Registration and hardware accessories.

In a spinal context, Automatic Registration serves as accessory to the Spine & Trauma navigation system.

3. Substantial Equivalence

Devices	Name	K-Number	Manufacturer
Subject Device	Automatic Registration	K203679	Brainlab AG
Predicate Device	Spine & Trauma NavigationSystem	K183605	Brainlab AG

Feature / Topic	Area	Changes of Automatic Registration in relation to thepredicate device K183605
Indications for use	General	Same as in predicate device; minor expansion for automaticregistration specific feature
Integration ofBrainlab IGS(computer) platforms	Compatibilitiesand HardwareComponents	Same basic functionality; added compatibility to a platform withminor differences
Automatic ImageRegistration	Compatibilities toexternal imagingdevices	Same basic functionality; further compatibilities added withminor differences
		Compatibility was added for a new intraoperative 3D imagingdevice for pre-calibration.
Instruments that canbe employed –NavigationAccessories	CompatibleInstruments andsoftware relevantHardware	Addition of hardware parts with minor differences.Same principle in registration of 2D and 3D images.Material and design adapted to fit requirements of UniversalAIR (Registration Matrix)

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Image /page/5/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The text and logo are in black and the background is white.

Feature / Topic	Area	Changes of Automatic Registration in relation to thepredicate device K183605
Automatic patientregistration	Software relevantbehavior andfeatures	Same basic functionality; minor modifications inGUI/functionality.The main functionality components of the software system staythe same.Additional instructions were added for automatic patientregistration using Universal AIR.Icons and graphical representations of scanner referencearrays were added to visualize the additionally integratedscanning devices.The basic concept of verification of registration accuracy priorto navigation remains unchanged.

Non-Clinical Testing:

1. Registration Accuracy Test Test Result:
- Mean navigation accuracy: 0.93mm ●
- . 95th percentile of single navigation accuracy: 1.80mm
- Total number of navigation points n=228 .

Above listed non-clinical performance testing demonstrates the equivalence of the navigation registration accuracy of the subject device to the predicate device. It was performed in a simulated test environment which matches the test scenario of the cleared device, where a mean registration accuracy of 1.26mm was measured.

Minor modifications to the test setup were required due to the device change where a Registration Matrix within the scan volume is used for automatic registration instead of infrared scanner markers in combination with a navigation calibration as in the cleared device. The navigated region of interest and measurement methods were not changed since these parameters are not affected by the device change.

An additional performance test demonstrated that the registration method is also applicable for the cervical spine and navigation accuracy in this region is consistent with the initial results listed above.

K203679 510(k) Summary

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Image /page/6/Picture/1 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a logo that appears to be three curved lines stacked on top of each other. The logo and the word are both in black and are set against a white background. The image is simple and clean, with a focus on the company name and logo.

Test results generated demonstrated better mean navigation accuracy and met stricter acceptance criteria (mean navigation accuracy: <= 1.5mm, 95th percentile of single navigation accuracy: <=2.5mm) compared to the predicate device (mean navigation accuracy: <=2.0mm; 95th percentile of single navigation accuracy: <=3.0mm). The total number of measured navigation points (n=228) and total number of scans used (m=50) were increased compared to performance testing of the predicate device (n=126; total number of scans used: m=32).

Conclusion

The changes described above do not alter intended use or the fundamental scientific technology of the device because they do not change the operating principle. Non-clinical performance tests demonstrated that device changes do not negatively affect registration accuracy. The changes to the Subject Device do not present new issues of safety and effectiveness when compared to the predicate device while still providing the benefit of an equally accurate registration resulting in an unchanged risk benefit ratio. Therefore, the devices are substantially equivalent.

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).