ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Device Description

ExacTrac Dynamic is a patient positioning device used in a radiotherapy environment as an addon system to standard linear accelerators. It uses patient planning and CT data to determine the patient's planned position and compares it via oblique x-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment is monitored with a surface camera and X-ray to ensure no misalignment due to patient movement.
ExacTrac Dynamic 1.1 is a modification of the previously cleared device ExacTrac Dynamic 1.0 that additionally features a Deep Inspiration Breath-Hold (DIBH) functionality to treat breast cancer. This functionality helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology. This functionality was not included in ExacTrac Dynamic 1.0. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined position with a maximum distance to critical structures like the heart. Additionally, the surface tracking functionality was extended, which monitors the patient after an initial 3rd party positioning.

AI/ML Overview

The provided text describes the 510(k) submission for Brainlab AG's ExacTrac Dynamic 1.1, a medical device for patient positioning and monitoring during radiation therapy. The key new features in version 1.1 are Deep Inspiration Breath-Hold (DIBH) functionality and an extended "Surface Only" tracking mode.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria with corresponding reported device performance values. Instead, it states the objectives for the clinical investigation of the new DIBH feature, which can be interpreted as acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Objectives for DIBH)	Reported Device Performance (Implied from "All acceptance criteria... were passed")
ETD can assist a human eligible for DIBH to reproduce a defined state of deep inspiration breath-hold (DIBH) within +/- 3 mm.	The device successfully met this criterion.
Regarding the pre-positioning within the DIBH workflow based on ETD's 3D surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.	The device successfully met this criterion.

Note: The document explicitly states, "All acceptance criteria for the successful completion of the study were passed." This implies that the device performance met or exceeded these criteria. However, specific numerical results or confidence intervals are not provided in this summary.

Study Details

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set (Clinical Investigation for DIBH):
- Study Population: 13 female subjects. These subjects were divided into:
  - Patient Population: Women diagnosed with breast cancer indicated for radiation therapy with DIBH, currently or previously treated with this technique. (Retrospective/Prospective unclear but likely prospective for the study itself).
  - Volunteer Population: Healthy women resembling breast cancer patients concerning physiognomy and age, able to perform deep and long DIBHs. (Prospective).
- Data Provenance: The document does not explicitly state the country of origin but implies a single-center clinical investigation ("single-center Clinical Investigation" on page 10). Given the manufacturer is German, it's possible the study was conducted in Germany or a location aligned with their operations. The data collection was prospective for the purposes of this clinical investigation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the clinical investigation. The "ground truth" for the DIBH study appears to be based on the device's ability to reproduce a target DIBH state and achieve a certain pre-positioning accuracy, which would likely be measured against independent, precise measurements by the study team, rather than expert interpretation of images. However, if any such expert review was involved, it's not detailed here.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The clinical investigation appears to focus on quantitative measurements of DIBH reproduction and pre-positioning accuracy, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done according to the provided text. The study described focuses on the device's ability to achieve specific accuracy targets for DIBH and pre-positioning, and does not compare human readers with or without AI assistance. The device is a patient positioning and monitoring system, not primarily an image interpretation AI.

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

The clinical investigation evaluates the "surface camera system-based components of the ETD DIBH module" in assisting human patients. While parts of the system operate algorithmically, the "clinical investigation" context implies the system's performance in aiding human execution of DIBH. However, the accuracy tests (e.g., "Accuracy Test: The test objective is to verify that accuracy specifications for positioning and monitoring of ExacTrac Dynamic are not affected by the selected workflow, treatment parameters and different phantom positions.") strongly suggest standalone algorithm performance was evaluated using phantoms in the general "Performance Data" section. Specific standalone results from these phantom tests are not detailed beyond the statement that requirements were met.

7. The Type of Ground Truth Used

For the DIBH clinical investigation, the ground truth was based on quantitative measurements related to:
- Reproduction of "a defined state of deep inspiration breath-hold" within +/- 3 mm, likely measured by a highly accurate external reference.
- Translational accuracy of pre-positioning "better than 6 mm," also presumably measured against a reference.
For the "Accuracy Test" mentioned in the Performance Data section, the ground truth was likely established against known, precise phantom positions and deviations.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size for a training set. This submission is for a modification (ExacTrac Dynamic 1.1) of an existing device (ExacTrac Dynamic 1.0). While the device uses "Deep Inspiration Breath-Hold (DIBH) functionality" which "helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology," it doesn't explicitly state that this new functionality is based on a machine learning model that required a specific training set from patient data. If it uses internal algorithms, those would have been developed and tested, but "training set" details are not discussed.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned (as the new features are described as functionalities, not necessarily trained AI models in the conventional sense), no information is provided on how its ground truth was established. If underlying algorithms were "trained," the method would depend on the type of algorithm (e.g., precise measurements on phantoms, or expert annotations if it involved image recognition/assessment).

Summary

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Brainlab AG % Chiara Cunico Manager RA Olof-Palme-Str. 9 Munich, 81829 GERMANY

Re: K220338

Trade/Device Name: ExacTrac Dynamic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 3, 2022 Received: February 18, 2022

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,

Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K220338

Device Name

ExacTrac Dynamic (1.1)

Indications for Use (Describe)

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

April 22, 2022

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
EstablishmentRegistration	8043933
Device Name	Medical charged-particle radiation therapy system
Trade Name	ExacTrac Dynamic
Product Code	IYE
Regulation Number	892.5050
Regulatory Class	II
Panel	Radiology
Predicate Devices	ExacTrac Dynamic (K201276)

1. Indications for Use

ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

2. Device Description

ExacTrac Dynamic 1.1 is a modification of the previously cleared device ExacTrac Dynamic 1.0 that additionally features a Deep Inspiration Breath-Hold (DIBH) functionality to treat breast cancer. This functionality helps correctly position the patient to a deep inspiration breath-hold level and then to monitor this position using surface tracking and x-ray positioning technology. This functionality was not included in ExacTrac Dynamic 1.0. The aim of this technology is to treat the patient only during breath-hold phases where the breast is at a defined position with a maximum distance to critical structures like the heart. Additionally, the surface tracking functionality was extended, which monitors the patient after an initial 3rd party positioning.

3. Substantial Equivalence

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Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
Indications forUse	ExacTrac Dynamic is intended to position patientsat an accurately defined point within the treatmentbeam of a medical accelerator for stereotacticradiosurgery or radiotherapy procedures, tomonitor the patient position and to provide a beamhold signal in case of a deviations in order to treatlesions, tumors and conditions anywhere in thebody when radiation treatment is indicated.	ExacTrac Dynamic is intended to position patientsat an accurately defined point within the treatmentbeam of a medical accelerator for stereotacticradiosurgery or radiotherapy procedures, tomonitor the patient position and to provide a beamhold signal in case of a deviations in order to treatlesions, tumors and conditions anywhere in thebody when radiation treatment is indicated.	No changes
Localizationtechnique	The camera detects both the patient surface andthe patient thermal surface which together, can beused to track the patient geometries.Stereo X-ray is acquired and compared with theplanned position (room based).CBCT data are imported from a from 3rd partyCBCT Device and compared with the plannedposition.	The camera detects both the patient surface andthe patient thermal surface which together, can beused to track the patient geometries.Stereo X-ray is acquired and compared with theplanned position (room based).CBCT data are imported from a from 3rd partyCBCT Device and compared with the plannedposition.	Same as the predicate device.
Generalworkflow:Patientpreparationbefore usingExacTrac	Uses implanted radio opaque fiducial markers orusing Body Markers Performing CT scanData import from treatment planning system	Uses implanted radio opaque fiducial markers orusing Body Markers Performing CT scanData import from treatment planning system	Same patient preparationmethod as the predicate
SoftwareUserManagement	Done via Windows user management according toour instructions	Done via Windows user management according toour instructions	Identical to the predicate
Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
DeepInspirationBreath-Hold(DIBH)	N/A	ExacTrac Dynamic 1.1 features a Deep InspirationBreath-Hold (DIBH) functionality to treat breastcancer. This functionality includes special featuresand workflows to correctly position the patient to adeep inspiration breath-hold level and then tomonitor this position using the ExacTrac surfacetracking and x-ray positioning technology. The aimof this technology is to treat the patient only duringbreath-hold phases where the breast is at adefined position with a maximum distance tocritical structures like the heart. These featureresults in an optional use of the patient feedbacksystem.	New feature added
Surface Only	N/A	Additionally, a separate workflow offers thepossibility to position the patient with a third-partypositioning device e.g., CBCT. The patientposition defined by the third-party device can beset as a reference for ExacTrac Dynamic whichallows monitoring the patient using ExacTrac'ssurface camera and X-ray system relative to thisposition. ExacTrac Dynamic 1.1 shall offerperforming this third-party positioning andExacTrac Dynamic monitoring workflow by onlyusing the surface tracking system - contrary toExacTrac Dynamic 1.0 where it was necessary toacquire X-ray images to set the third party definedpatient position as a reference for ExacTracDynamic	New feature added
X-rayGenerator	The X-ray Generator consists of two HFe 601 X-ray Generators. Each generator controls one X-ray tube. Software control of X-ray settings.Updated electronic board for the updated tubes.	No change compared to ExacTrac Dynamic 1.0	No changes
Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
ExacTracConsole	ExacTrac Console (System start/shut down, X-rayacquisition)Image: ExacTrac Dynamic 1.0 K201276 Console	ExacTrac Console (System start/shut down, X-rayacquisition)Image: ExacTrac Dynamic 1.1 Console	No change
X-ray Sources	Varex G-892 Sources (Housing: Varex B-130)	Varex G-892 Sources (Housing: Varex B-130)	No change
Flat PanelDetectorincludingPower Supply	Flat Panel DetectorVarex PaxScan 3030DX	no change compared to predicate	No change

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Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
Cameras	3D and Thermal CamerasManufacturer (3D): Cognex Ireland Limited Type:A5060Manufacturer (Thermal): Flir Systems AB Type:A65 F25Image: CameraThe camera is used to detect the patient's thermaland spatial surface. The thermal topology is usedto prevent the surface registration algorithm fromfalling into local minima. Thus, both surfaces areused to track patient's position.	3D and Thermal CamerasManufacturer (3D): Cognex Ireland Limited Type:A5060Manufacturer (Thermal): Flir Systems AB Type:A65 F25Image: CameraThe camera is used to detect the patient's thermaland spatial surface. The thermal topology is usedto prevent the surface registration algorithm fromfalling into local minima. Thus, both surfaces areused to track patient's position.	no change
Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
Wall mountedTouch ScreenMonitor	Image: ExacTrac Dynamic 1.0 K201276	Image: ExacTrac Dynamic 1.1	No change
On Floor X-ray sourcescovers	X-ray tubes within On-Floor BoxesX-ray Tubes within Floor	X-ray tubes within On-Floor BoxesX-ray Tubes within Floor	No change
Features	ExacTrac Dynamic 1.0 K201276 (PrimaryPredicate)	ExacTrac Dynamic 1.1 (Subject Device)	Comments
In Floor	The In-Floor is used to install on Varian andElekta LINAC's	Update of In- Floor Covers including a yellow lightand updated design.	Update of design, includingadded light. No functionalchange
PatientFeedbackSystem	Not included	The Patient Feedback System helps patientsvisualize their own respiration and to achieve acorrect breath hold.Therefore, the mirror is attached the patient headand they can see the in Room Monitor.The Monitor shows the live respiratory status andthe DIBH Gating Window. The System is only forsupporting the patients, a treatment without is alsopossible.	New part introduced due to theaddition of DBIH feature.
X-rayCalibration	Image: X-ray Calibration	Image: X-ray Calibration	No change
CameraCalibration	Thermal to 3D Calibration PhantomA phantom to calibrate the 3D camera and thethermal camera added.	Thermal to 3D Calibration PhantomA phantom to calibrate the 3D camera and thethermal camera added.	No change

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4. Performance Data

The following tests were conducted:

. Compatibility Tests:
Cybersecurity Tests: ●
- o ETD Pen Test
- o Vulnerability Test
. Accuracy Test: The test objective is to verify that accuracy specifications for positioning and monitoring of ExacTrac Dynamic are not affected by the selected workflow, treatment parameters and different phantom positions. Also, within this test plan the correct display of deviation indicators and X-ray/DRR overlays as well as the correct transfer and adjustment of shifts and rotations to the patient support system.
. Biological Evaluation: It examines the materials used in the device, considers the application of biological and chemical tests, and the history of safety and efficacy of the device materials in humans.
. Usability Evaluation
Routine Software verification to confirm that the specifications met the requirements

Clinical Validation

For the new feature, a clinical evaluation was performed which was based on literature review, performance evaluation on phantoms and a clinical investigation for DIBH.

Overview of the Pre-market, single-center Clinical Investigation:

Since the functionality to generate a respiratory signal is new to the Subject Device, a clinical investigation was performed to evaluate the surface camera system-based components of the ETD DIBH module.

Study Objectives:

1. ETD can assist a human eligible for DIBH (Paul Keall, 2006) to reproduce a defined state of deep inspiration breath-hold (DIBH) within +/- 3 mm.
1. Regarding the pre-positioning within the DIBH workflow based on ETD's 3D' surface imaging, the surface of a patient - being in state of free-breathing - can be prepositioned with a translational accuracy better than 6 mm.

Study population: 13 female subjects.

The first study population (patient population), consisted of subjects who are women who were diagnosed with breast cancer that is indicated for a treatment with radiation therapy with the DIBH technique and who are currently, or who have currently been treated with this technique.

The second study population (volunteer population) consisted of subjects who are healthy women who resembled patients that are typically diagnosed with breast cancer as far as possible, concerning their physiognomy and age, and who can perform sufficiently deep and long DIBHs.

All acceptance criteria for the successful completion of the study were passed. No adverse events or adverse device deficiencies were observed.

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5. Conclusion

Based on the clinical and non-clinical testing conducted for the Subject Device as listed above and based on the Substantial Equivalence discussion, the Subject Device was demonstrated to be as safe and effective as the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.