The Brainlab Elements Trajectory Planning software is intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological 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

Trajectory planning is a software device which 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, segmentations, trajectories, etc.). 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).

The software is used in three different configurations:

1. Trajectory (Element): allows the creation of trajectories
1. Stereotaxy (Element); allows the creation of trajectories and supports also frame based procedures
Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images

The software takes (DICOM) data as input and provides (DICOM) data as outputs. This data can be transferred by removable memory devices like USB sticks or via network.

The user interaction can be done with a touchscreen and/or with a mouse, optionally combined with a keyboard on a laptop which fulfill minimum requirements.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA regarding Brainlab AG's "Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization" software. It generally certifies substantial equivalence to a predicate device and outlines the software's intended use and performance data. However, it does not contain the detailed information required to fill out the table and answer all the questions about specific acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:

"Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,"
"Software verification was carried out for all the specifications and all tests met the acceptance criteria."
"Data from the Summative Usability test concluded that there is no indication that the use of the device could lead to critical errors resulting in a hazardous situation for patient or user."
"Clinical claims were supported via data from literature and post market data collected."

This indicates that internal testing was performed, acceptance criteria were met, and clinical claims were supported, but the specific metrics, criteria values, and detailed study methodologies are not included in this summary document. Such details would typically be found in the actual verification and validation reports submitted to the FDA, not in the publicly available 510(k) summary letter.

Therefore, many sections of your request cannot be fulfilled based solely on the provided text.

Here's an attempt to fill out what can be inferred or explicitly stated, with clear indications of what information is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Software Verification	All specifications met.	"all tests met the acceptance criteria."
Usability	No critical errors leading to hazardous situations for patient or user.	"no indication that the use of the device could lead to critical errors resulting in a hazardous situation for patient or user."
Clinical Performance	(Not specified in detail)	"Clinical claims were supported via data from literature and post market data collected." (Specific metrics and values are not provided.)
Risk Analysis	All relevant hazards considered, risk control complete, measures in place.	"risk analysis shows that all relevant hazards have been taken into consideration, that risk control is complete and that the corresponding measures are in place."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified for the software verification or clinical evaluation directly. It states "data from literature and post market data collected" for clinical claims, which implies a mix, but no specifics about origin or retrospective/prospective nature are given for the actual validation data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The document mentions "clinical claims were supported via data from literature and post market data collected" but does not detail how ground truth was established for any specific test set, nor the involvement or qualifications of experts for such ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified.

5. 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

Not explicitly mentioned. The document primarily focuses on verifying the software's functionality and safety, not on comparative effectiveness with human readers or AI assistance. The "Lead Localization (Element)" module allows "automatic detection of leads in post-operative images," indicating an AI component, but no MRMC study details or effect sizes are provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The software includes modules like "automatic detection of leads in post-operative images." While this implies an algorithm-only component, the document does not explicitly state whether a standalone performance study report (without human intervention) was conducted as per typical regulatory requirements, beyond the general statement of "software verification."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified for software verification or the "automatic lead detection." For general "clinical claims," it states "data from literature and post market data collected," which could implicitly include various types of ground truth (e.g., surgical outcomes, pathology, expert review from literature), but this is not detailed for a specific validation set.

8. The sample size for the training set

Not specified. This document pertains to regulatory clearance based on substantial equivalence and performance verification; it does not detail the specifics of machine learning model training (if applicable to features like "automatic lead detection").

9. How the ground truth for the training set was established

Not specified. (See point 8).

Summary

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November 3, 2021

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

Re: K211544

Trade/Device Name: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 29, 2021 Received: October 4, 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 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 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,

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) K211544

Device Name

Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization

Indications for Use (Describe)

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

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

November 3, 2021

General Information
Manufacturer	Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany
Establishment Registration	8043933
Trade Name	Trajectory Planning, Elements Trajectory Planning, Elements LeadLocalization
Classification Name	Neurological Stereotaxic Instrument
Product Code	HAW
Regulation Number	882.4560
Regulatory Class	Class II
Panel	Neurology
Predicate Device(s)	iPlan K101627
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. Indication for Use

The 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.

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

2. Device Description

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The software is used in three different configurations:

1. Trajectory (Element): allows the creation of trajectories
1. Stereotaxy (Element); allows the creation of trajectories and supports also frame based procedures
Lead Localization (Element): allows the creation of trajectories and automatic detection of ဒေ.
က leads in post-operative images

The software takes (DICOM) data as input and provides (DICOM) data as outputs. This data can be transferred by removable memory devices like USB sticks or via network.

The user interaction can be done with a touchscreen and/or with a mouse, optionally combined with a keyboard on a laptop which fulfill minimum requirements.

3. Substantial Equivalence

The Subject Device is similar to the predicate device in terms of:

Support of frame based procedures including stereotactic localization and arc settings । calculation
-Trajectory planning on multi-modal co-reqistration images
Multiple views for reconstructed medical images -
-Visualization for supplemental information like segmented structure and fiber tracts
Definition and usage of AC/PC coordinate system for Trajectory Planning -

The Subiect Device differs from the predicate device in terms of:

Additional indications included for SEEG procedures, DBS procedures, Probe placement -
-Spine and ENT indications
Additional stereotactic hardware support (Elekta Vantage) -
Predicate device was split into multiple medical software modules -
-Addition of automatic lead detection in CT images
User Interfaces -

4. Performance Data

Software Verification

Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,"

Software verification was carried out for all the specifications and all tests met the acceptance criteria. In addition to the verification activities, the risk analysis shows that all relevant hazards have been taken into consideration, that risk control is complete and that the corresponding measures are in place.

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Usability

Data from the Summative Usability test concluded that there is no indication that the use of the device could lead to critical errors resulting in a hazardous situation for patient or user.

Clinical Evaluation

Clinical claims were supported via data from literature and post market data collected.

5. Conclusion

The comparison of the Subject Device with the predicate device shows that the device has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification and validation activities ensured that the design specifications are met and that the Subject Device 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).