Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.

This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):

Catheter placement
Depth electrode placement (SEEG procedures)
Lead placement and detection (DBS procedures)
Probe placement
Cranial biopsies

Device Description

Brainlab Elements Trajectory Planning is a software used to plan minimally invasive possible pathways (Trajectories') for surgical instruments on scanned images. It is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co-registrations, seqmentations, fiber tracts created by compatible applications and stored as DICOM data) and the planning of trajectories based on this data. The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g.: stereotactic arc settings or FHC STarFix platform settings). Depending on the workflow and available licenses, Brainlab Elements Trajectory Planning might be used in different roles where only specific application features are available.

The following roles are available for Trajectory Planning:

Trajectory (Element): allows the creation of trajectories
Stereotaxy (Element): allows the creation of trajectories and supports stereotactic procedures based on Stereotactic Arc Settings or FHC STarFix platform settings
Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images.

All roles are enabled to be used for cranial trajectory planning procedures after installation of Trajectory as well as the corresponding workflow files for Cranial Planning, Stereotactic Planning or Post-Op Review.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Brainlab Elements - Trajectory Planning (2.6) device. It acts as a K-number summary, primarily comparing the new device to existing predicate devices to establish substantial equivalence. While it discusses certain "performance data" and "verification," it does not present a detailed study with acceptance criteria and reported device performance in the format of clinical trial results or a validation study with specific metrics.

The document states that the objective of "validative tests" was to verify that the accuracy and robustness of automatically and semi-automatically detected WayPoint anchors used in FHC's 4mm and 5mm bone anchors were "non-inferior" to a specified predicate software application. It also states that "the acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fulfilled." However, the specific acceptance criteria and the reported quantitative performance metrics are not included in this document.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC study details, or specific ground truth methodologies for a standalone performance study, as these details are not provided in the given text.

Based on the information provided, here's what can be inferred and what remains unknown regarding the "study" mentioned:

Known Information (based on the provided text):

Device Performance Focus: The performance data section focuses on "FHC anchor detection" and "summative usability evaluation."
FHC Anchor Detection Objective: To verify that the accuracy and robustness of Brainlab's automatic and semi-automatic WayPoint anchor detection on CT data for FHC's 4mm and 5mm bone anchors are non-inferior to the predicate "SW application WayPoint™ Planner Software."
Acceptance Criteria for Anchor Detection: The text states, "The acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fulfilled." (However, the specific criteria are not provided.)
Summative Usability Evaluation: This evaluation covered the support of STarFix platforms for DBS procedures, including detection of WayPoint bone anchors and platform planning. New GUI functionalities (locking of plans, overlay/blending of fused images, and new interaction with coordinates) were also included.
Study Type Mentioned: "Validative tests" for anchor detection and "summative evaluation" for usability.
Conclusion: The manufacturer concluded that "the performed verification and validation activities established that the set requirements were met and that the device performs as intended."

Unknown Information (not provided in the text):

Table of Acceptance Criteria and Reported Device Performance: This critical information is missing. The document only states that acceptance criteria were fulfilled, not what they were or the quantitative results achieved.
Sample Size Used for the Test Set and Data Provenance: The document does not specify the number of cases or images used in the FHC anchor detection or usability tests, nor does it state the country of origin of the data or if it was retrospective/prospective.
Number of Experts Used to Establish Ground Truth and Qualifications: The number and qualifications of experts involved in establishing ground truth (for anchor detection) or participating in the usability evaluation are not mentioned.
Adjudication Method: No information is provided regarding how disagreements or the ground truth was established for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe an MRMC study comparing human readers with and without AI assistance. The non-inferiority claim for anchor detection is against a software application, not a human reader.
Standalone (Algorithm Only) Performance: While the "FHC anchor detection" seems to refer to algorithm performance, specific metrics (e.g., sensitivity, specificity, accuracy for anchor detection) of the algorithm in a standalone capacity are not provided. The non-inferiority is stated against another software product, not against a defined ground truth with quantitative metrics.
Type of Ground Truth Used: For the FHC anchor detection, it's implied that there's a ground truth for "accuracy and robustness" of anchor detection, likely based on known positions or expert annotations of anchors. However, the specific method (e.g., expert consensus, physical measurements) is not detailed. For usability, the ground truth would be user feedback and observed performance.
Sample Size for the Training Set: No information is provided about the training set for any machine learning components within the device (if any). The context suggests this is more about software functionality and accuracy validation rather than a deep learning model requiring a large training set.
How Ground Truth for the Training Set Was Established: This information is also absent.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 19, 2023

Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, BY 81829 Germany

Re: K223552

Trade/Device Name: Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 25, 2022 Received: November 25, 2022

Dear Sadwini Suresh:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for "Adam D. Pierce -S". The date of the signature is 2023.04.19, and the time is 18:01:44 -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K223552

Device Name

Brainlab Elements Trajectory Planning (2.6), Elements Lead Localization, Elements Trajectory Planning Cranial

Indications for Use (Describe)

This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):

· Catheter placement
· Depth electrode placement (SEEG procedures)
· Lead placement and detection (DBS procedures)
· Probe placement
· Cranial biopsies

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K223552 Page 1 of 9

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
Establishment Registration	8043933
Trade Names	Brainlab Elements - Trajectory Planning (2.6) Elements Stereotaxy Elements Lead Localization Elements Trajectory Planning Cranial
Classification Name	Neurological Stereotaxic Instrument
Product Code	HAW
Regulation Number	882.4560
Regulatory Class	II
Panel	Neurology
Primary Predicate Device	(K211544) Brainlab Elements Trajectory Planning (2.5)
Additional Predicate Device	(K092192) Waypoint Stereotactic System
Contact Information
Primary Contact	Sadwini SureshQM ConsultantRegulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com
Alternate Contact	Chiara CunicoSenior Manager Regulatory AffairsPhone: +49 89 99 15 68 0Email: chiara.cunico@brainlab.com

1. Indications for Use

Brainlab Elements - Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.

lts use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/ device can be identified relative to images of the anatomy.

This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):

o Catheter placement
Depth electrode placement (SEEG procedures) o
Lead placement and detection (DBS procedures) 0
Probe placement ●
Cranial biopsies

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2. Device Description

The following roles are available for Trajectory Planning:

· Trajectory (Element): allows the creation of trajectories
· Stereotaxy (Element): allows the creation of trajectories and supports stereotactic procedures based on Stereotactic Arc Settings or FHC STarFix platform settings

· Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images.

3. Substantial Equivalence

The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:

Device	Name
Primary Predicate Device	(K211544) Brainlab Elements Trajectory Planning (2.5)
Additional Predicate device	(K092192) Waypoint Stereotactic System

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Topic/ Feature	Primary Predicate:(K211544) Brainlab Elements TrajectoryPlanning (2.5)	Subject Device (Trajectory Planning 2.6)	Comment
Indications for use	The Brainlab Elements Trajectory Planningsoftware is intended for pre-, intra- andpostoperative image-based planning and reviewof either open or minimally invasiveneurosurgical and neurological procedures.Its use is indicated for any medical condition inwhich the use of stereotactic surgery may beappropriate for the placement ofinstruments/devices and where the position ofthe instrument/ device can be identified relativeto images of the anatomy.This includes, but is not limited to, the followingCranial procedures (including frame-basedstereotaxy and frame alternative-basedstereotaxy):- Catheter placement- Depth electrode placement (SEEG procedures)- Lead placement and detection (DBSprocedures)- Probe placement- Cranial biopsies	The Brainlab Elements Trajectory Planningsoftware is intended for pre-, intra- andpostoperative image-based planning and reviewof either open or minimally invasiveneurosurgical and neurological procedures.Its use is indicated for any medical condition inwhich the use of stereotactic surgery may beappropriate for the placement ofinstruments/devices and where the position ofthe instrument/ device can be identified relativeto images of the anatomy.This includes, but is not limited to, the followingCranial procedures (including frame-basedstereotaxy and frame alternative-basedstereotaxy):- Catheter placement- Depth electrode placement (SEEG procedures)- Lead placement and detection (DBSprocedures)- Probe placement- Cranial biopsies	No Changes compared to theprimary predicate.
User Profile	The target user group are healthcareprofessionals educated for the planning and	The target user group are healthcareprofessionals educated for the planning and	No Changes compared to theprimary predicate.
Topic/ Feature	Primary Predicate:	Subject Device (Trajectory Planning 2.6)	Comment
	(K211544) Brainlab Elements TrajectoryPlanning (2.5)
	execution of functional neurosurgery procedures.These include neurosurgeons and neurologists.	execution of functional neurosurgery procedures.These include neurosurgeons and neurologists.
Hardwarerequirements	Trajectory Planning can be used on computerplatforms that fulfill the defined minimumrequirements:- Operating System: Windows 7 64bit SP1- Minimum 4 logical cores- Minimum RAM: 6 GB- Graphics: Direct X compatible- Display Resolution: 1920 x 1080 (Full HD)	Trajectory Planning can be used on computerplatforms that fulfill the defined minimumrequirements:- Operating System: Windows 7 64bit SP1- Minimum 4 logical cores- Minimum RAM: 6 GB- Graphics: Direct X compatible- Display Resolution: 1920 x 1080 (Full HD)	No Changes compared to theprimary predicate.
View and Adjust	N/A	Adjust Windowing via dedicated windowingparameter controls and presets	New GUI functionality addedto the Subject Device. Onlyadditional GUI options areoffered for adjusting thewindowing
Measurements	Make Measurements in the selected dataset withdifferent measurement tools:- Margin Measurement: Create a margin around atrajectory- Distance Measurement: Measure the distancebetween two points	Make Measurements in the selected dataset withdifferent measurement tools:- Point Measurement: Mark individual pointsin the dataset and get additional informationsuch as the DICOM coordinates of the point,the grey values of the image dataset at thispoint or the AC/PC coordinates of the point- Angle Measurement: Measure the anglebetween two lines	Only additional tool options formeasuring points, distances orangles are offered .
Topic/ Feature	Primary Predicate:(K211544) Brainlab Elements TrajectoryPlanning (2.5)	Subject Device (Trajectory Planning 2.6)	Comment
Supported Non-BrainlabStereotacticHardware	N/A	- Multiline Measurement: Measure thedistance between several pointsInomed SUSy Arc interfacing with InomedTitanium or Inomed Open Ceramic Headring	Additional stereotactic arcsystem supported with thesubject device.
StereotacticPlatform Support	N/A	FHC STARFIX Stereotactic Platform is supported	Added support of FHC STARFIXStereotactic Platforms

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Topic/ Feature	Additional Predicate:	Subject Device (Trajectory Planning 2.6)	Comment
	(K092192) Waypoint Stereotactic System
Indications for use	The WayPoint Stereotaxic System is intendedto be used with commercially availablestereotactic systems for neurosurgicalprocedures which require the accuratepositioning of microelectrodes, stimulatingelectrodes, implantable electrodes or otherinstruments in the brain or nervous system.	The Brainlab Elements Trajectory Planningsoftware is intended for pre-, intra- andpostoperative image-based planning andreview of either open or minimally invasiveneurosurgical and neurological procedures.Its use is indicated for any medical conditionin which the use of stereotactic surgery maybe appropriate for the placement ofinstruments/devices and where the position ofthe instrument/ device can be identifiedrelative to images of the anatomy.This includes, but is not limited to, thefollowing Cranial procedures (including frame-based stereotaxy and frame alternative-basedstereotaxy):- Catheter placement- Depth electrode placement (SEEGprocedures)- Lead placement and detection (DBSprocedures)- Probe placement	Similar indications for use.
Topic/ Feature	Additional Predicate:	Subject Device (Trajectory Planning 2.6)	Comment
	(K092192) Waypoint Stereotactic System
		- Cranial biopsies
	The application allows the user to configureand review trajectory planning results to berealized using FHC STarFix Platforms. Theseare patient/case specific framelessstereotactic platforms manufactured anddelivered by FHC Inc.	The application allows the user to configureand review trajectory planning results to berealized using FHC STarFix Platforms. Theseare patient/case specific framelessstereotactic platforms manufactured anddelivered by FHC Inc.	No changes.
Anchor Detection	User can detect (FHC WayPoint) anchors onCT scans that are used as interface to thepatients head (based on stereotacticregistration).	User can detect (FHC WayPoint) anchors onCT scans that are used as interface to thepatients head (based on stereotacticregistration).	No changes.
StereotacticPlatforms	The following FHC STarFix StereotacticPlatforms can be used (as selected by theuser):- Four legged Unilateral Platforms(2h2h)- Four legged Bilateral Platforms(2h2h, 2b2b)- Three Legged Unilateral Platforms(Unilateral)- Staged Bilateral Platforms (EpilepsyMulti-Hub)	The following FHC STarFix StereotacticPlatforms can be used (as selected by theuser):- Four legged Unilateral Platforms(2h2h)- Four legged Bilateral Platforms (2h2h,2b2b)- n/a- n/a	Minor Difference- Only four legged stereotacticpositioning platforms are supported(reducing the number of options)- Provided options are similarto the predicate.
Registration	The following registration constraints areapplied:	The following registration constraints areapplied:	- Supporting only 4 anchorsfurthermore prevents wrongmounting of the platform
Topic/ Feature	Additional Predicate:(K092192) Waypoint Stereotactic System	Subject Device (Trajectory Planning 2.6)	Comment
	- One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors- 3 or 4 anchors are supported- Anchor detections have to be accepted by the user	- One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors- Only 4 anchors are supported- Anchor detections have to be accepted by the user	Overall functionality is similar to the predicate.

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K223552
Page 8 of 9

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4. Performance Data

Verification

Software Verification:

Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity.

Bench Testing

In addition to the routine verification tests, the following performance tests were carried out for the Subject Device.

FHC anchor detection:

The objective of these validative tests is to verify for Trajectory Planning 2.6, that accuracy and robustness of the automatic and semi-automatic WayPoint anchor detection on CT data for FHC's 4 mm and 5 mm bone anchors are non-inferior to the SW application WayPoint™ Planner Software. The acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fullfilled.

Summative Usability Evaluation:

Within version 2.6 of Trajectory Planning (Subject Device) the support of STarFix plaforms for DBS procedures including detection of WayPoint bone anchors and platform planning was introduced and thus the whole workflow of planning a STarFix platform in Stereotaxy Element was subject to summative evaluation. In addition, locking of plans and overlay/blending of two fused images sets were added as features as well and were included in the summative evaluation.

Additionally, the new interaction with the coordinates (e.g.AC/PC) caused by GUI changes was also evaluated.

5. Conclusion

The performed verification and validation activities established that the set requirements were met and that the device performs as intended.

The Subject Devices' comparison with the Predicate Devices establishes that they have similar functionality, intended use and technological characteristics. Therefore, we consider that the Subject Device can be considered substantially equivalent to the predicate device.

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).