(161 days)
Not Found
No
The description focuses on image processing and comparison for positioning and monitoring, without mentioning AI/ML algorithms or training/testing data sets.
No
This device is for positioning and monitoring patients during radiation treatment; it does not directly administer therapy or treat disease itself.
No
This device is intended for patient positioning and monitoring during radiotherapy, not for diagnosing disease or medical conditions. It helps align the patient for treatment and ensures they remain in the correct position.
No
The device description explicitly mentions hardware components such as X-ray systems, thermal-surface cameras, workstations, and interconnection hardware. It is described as an "add-on system to standard linear accelerators (linacs)," indicating a physical integration with existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "positioning 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". This describes a device used in vivo (within the living body) during a medical treatment procedure.
- Device Description: The description details a system that uses imaging modalities (X-ray, CT, thermal-surface camera, CBCT) to determine and monitor the patient's position relative to a treatment beam. This is a physical positioning and monitoring system, not a device that analyzes biological samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is entirely focused on patient positioning and monitoring during radiotherapy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. ExacTrac Dynamic does not fit this definition.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
ExacTrac Dynamic (ETD) is a patient positioning and monitoring device used in a radiotherapy environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy treatment plans and the associated computed tomography (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, the patient is monitored with a thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient movement. Positioning and monitoring are also possible in combination with implanted markers. By defining the marker positions, ExacTrac Dynamic can position the patient by using X-rays and thereafter monitor the position during treatment.
Additionally, ExacTrac Dynamic features a breath-hold (BH) functionality to serve as a tool to assist respiratory motion management. This functionality includes special features and workflows to correctly position the patient at a BH level and thereafter monitor this position using surface tracking. Regardless of the treatment indication, a correlation between the patient's surface and internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this technique is to treat the patient only during breath hold phases where the treatment target is at a certain position to reduce respiratory-induced tumor motion and to ensure a certain planned distance to OARs such as the heart. In addition to the X-ray based positioning technique, the system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has been used to position the patient).
The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the X-ray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), X-ray, thermal-surface camera, Cone-Beam CT (CBCT)
Anatomical Site
Anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiotherapy environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing has been conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level.
Bench Tests:
- RIGID BODY SURFACE MONITORING ACCURACY TEST: The accuracy of the surface based monitoring functionality of ExacTrac Dynamic 2.0 was checked using a new camera revision (ETD 3D Camera A5060 (45401B) with a new LED) and an in-house phantom. The goal was to prove feasibility of surface based patient monitoring for use in radiotherapy, using AAPM Task Group 1472 guidelines as reference.
- WORKFLOW & ACCURACY TEST EXACTRAC DYNAMIC: This test was to verify that accuracy specifications for patient positioning and monitoring at phantom treatment with ExacTrac Dynamic are not affected by relevant conditions, settings and workflows.
- RESPONSE TIME MEASUREMENT: The test measures the time between phantom movement and the correspondingly created Beam-off signal. The time between phantom movement and the appearance of the "out of tolerance" signal on the monitor is tracked.
- VERIFICATION OF THE RADIATION ISOCENTER CALIBRATION IN ETD 2.0: This test is intended to demonstrate that the Radiation Isocenter Calibration in ETD 2.0 is not inferior to the previous, well-established Radiation Isocenter Calibration in ETD 1. by more than a given threshold.
No clinical testing was required for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
July 24, 2024
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Brainlab AG % Sadwini Suresh QM Consultant Olof-Palme Str.9 Munich, 81829 GERMANY
Re: K240431
Trade/Device Name: ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: February 13, 2024 Received: February 14, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Loran Werther
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
K240431
Device Name
ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
Exactrac Dynamic Surface
Indications for Use (Describe)
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.
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
July 24, 2024
| General Information | |
|---|---|
| Manufacturer | Brainlab AG |
| Olof-Palme-Str.9 | |
| Munich, 81829 | |
| Germany | |
| Establishment Registration | 8043933 |
| Device Name | ExacTrac Dynamic 2.0 |
| Trade Name | ExacTrac Dynamic; ExacTrac Dynamic Surface |
| Classification Name | Medical charged-particle radiation therapy system |
| Product Code | IYE |
| Regulation Number | 892.5050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device and K | |
| Number | K220338; ExacTrac Dynamic 1.1 |
| Contact Information | |||
|---|---|---|---|
| Primary Contact | Alternate Contact | ||
| Sadwini Suresh | Regulatory Affairs Brainlab | ||
| QM Consultant | Phone: +49 89 99 15 68 0 | ||
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 | ||
| Email: regulatory.affairs@brainlab.com | Email: regulatory.affairs@brainlab.com |
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 (ETD) is a patient positioning and monitoring device used in a radiotherapy environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy treatment plans and the associated computed tomography (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, the patient is monitored with a thermal-surface camera and X-ray imaging to
4
Image /page/4/Picture/0 description: The image shows a stylized, abstract symbol in a vibrant pink color. The symbol appears to be composed of three interconnected, flowing shapes, possibly resembling stylized letters or decorative elements. The shapes are stacked vertically, creating a unified design that is eye-catching and distinctive.
ensure that there is no misalignment due to patient movement. Positioning and monitoring are also possible in combination with implanted markers. By defining the marker positions, ExacTrac Dynamic can position the patient by using X-rays and thereafter monitor the position during treatment.
Additionally, ExacTrac Dynamic features a breath-hold (BH) functionality to serve as a tool to assist respiratory motion management. This functionality includes special features and workflows to correctly position the patient at a BH level and thereafter monitor this position using surface tracking. Regardless of the treatment indication, a correlation between the patient's surface and internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this technique is to treat the patient only during breath hold phases where the treatment target is at a certain position to reduce respiratory-induced tumor motion and to ensure a certain planned distance to OARs such as the heart. In addition to the X-ray based positioning technique, the system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has been used to position the patient).
The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the X-ray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).
3. Substantial Equivalence
For the Substantial Equivalence determination, comparison of the Subject Device features with the following predicate device(s) was carried out:
ExacTrac Dynamic 1.1; K220338
The predicate was chosen since it's the predecessor and similar to the subject device with respect to the indications for use, technological characteristics and use cases.
The main differences compared to the predicate device is providing the 'Surface Only' Workflow. The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the Xray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).
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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized caduceus symbol on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
| Topic/ Feature | Predicate Device | Subject Device |
|---|---|---|
| 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 deviations in order to treat | ||
| lesions, tumors and conditions anywhere in the body when | ||
| radiation treatment is indicated. | 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 deviations in order to treat lesions, tumors and | ||
| conditions anywhere in the body when radiation | ||
| treatment is indicated. | ||
| Localization | ||
| technique based | ||
| on: | The camera detects both the patient surface and the patient | |
| thermal surface which together, can be used to track the | ||
| patient geometries. | ||
| Stereo X-ray is acquired and compared with the planned | ||
| position (room based). | ||
| CBCT data are imported from a from 3rd party CBCT Device | ||
| and compared with the planned position. | ExacTrac Dynamic (ETD) :The camera detects both | |
| the patient surface and the patient thermal surface | ||
| which together, can be used to track the patient | ||
| geometries. | ||
| Stereo X-ray is acquired and compared with the | ||
| planned position (room based). | ||
| CBCT data are imported from a from 3rd party CBCT | ||
| Device and compared with the planned position. | ||
| ExacTrac Dynamic Surface (ETDS): | ||
| The camera detects both the patient surface and the | ||
| patient thermal surface which together, can be used | ||
| to track the patient geometries/ position. | ||
| No X-Ray acquisition required. | ||
| Topic/ Feature | Predicate Device | Subject Device |
| ETD Preparation | ||
| and Review | ||
| workflow | Preparation: | |
| • Import of RT Dicom | ||
| • Define patient related settings | ||
| • Define Template |
Review
• Review of treatment
• Approval of treatment | Preparation:
• Import of RT Dicom
• Define patient related settings
• Define Template
Review
• Review of treatment
• Approval of treatment
Additional minor Bugfixes |
| User Management
setup | Done via Windows user management according to our
instructions | Done via Windows user management according to
our instructions
Additional minor Bugfixes |
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Image /page/6/Picture/0 description: The image shows a stylized, abstract symbol in a bright pink color. The symbol appears to be composed of three stacked elements, each resembling a simplified, curved shape. The overall design has a flowing, organic feel, and the bright pink color makes it stand out against a white background.
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Image /page/7/Picture/0 description: The image shows a pink symbol that appears to be a stylized representation of three snakes stacked on top of each other. The snakes are facing to the left and have a curved shape. The symbol is simple and abstract, with no other details or background elements present.
| Topic/ Feature | Predicate Device | Subject Device |
|---|---|---|
| Deep Inspiration | ||
| Breath-Hold (DIBH / | ||
| Breath Hold (BH) | ||
| workflow | Deep Inspiration Breath-Hold (DIBH) functionality to assist | |
| respiratory motion management. This functionality includes | ||
| special features and workflows to correctly position the | ||
| patient to breath-hold level and then to monitor this position | ||
| using the ExacTrac surface tracking and x-ray positioning | ||
| technology. During breath-Hold the Linac Beam is enabled. | ||
| While the patient is not in position the beam of the LINAC will | ||
| be hold. | ||
| 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. | ExacTrac Dynamic: | |
| Additionally, ExacTrac Dynamic 2.0 extended the | ||
| deep inspiration breath hold to Breath-Hold (BH) | ||
| functionality to treat breast and thorax cancer | ||
| patients. | ||
| Additional minor Bugfixes | ||
| ExacTrac Dynamic Surface: | ||
| Workflow adaption to make a BH with external | ||
| imaging for positioning and Surface Tracking Unit | ||
| for monitoring | ||
| Additional minor Bugfixes | ||
| Topic/ Feature | Predicate Device | Subject Device |
| Surface Only | ||
| workflow | The ExacTrac Dynamic Surface Only workflow enables | |
| patient monitoring by surface tracking after 3rd party | ||
| positioning, e.g. by CBCT, without using X-ray images as | ||
| reference or for monitoring. X-ray imaging is disabled within | ||
| this workflow. | ExacTrac Dynamic: | |
| N/A, no change to ETD 1.1 | ||
| Additional minor Bugfixes |
ExacTrac Dynamic Surface
The Surface Only workflow is provided as for
ExacTrac Dynamic 1.1 with the following
modifications:
- Surface tracking during 3rd Party Positioning is
provided to set the reference point for the
treatment surface monitoring - Non-coplanar treatment angles are supported
until a limited range (Only up to +-30°) - Prepositioning can be based on surface
reference from previous treatment sessions
The workflow can be executed on a HW platform not
providing X-ray imaging components. For this setup
a specific calibration function is introduced. |
| Patient Feedback
Glasses | N/A | Patient Feedback Glasses provide an alternative
solution to the Patient Feedback System to allow the
patient to see the room monitor and on it the live
respiratory status and the BH Gating Window. |
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Image /page/8/Picture/0 description: The image shows a stylized, abstract symbol in a vibrant pink color. The symbol appears to be composed of three identical, curved shapes stacked vertically on top of each other. The shapes resemble a stylized letter or a decorative flourish, with a flowing, calligraphic quality. The overall impression is one of elegance and artistic design.
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Image /page/9/Picture/0 description: The image shows a stylized symbol in a bright pink color. The symbol appears to be composed of three curved shapes stacked vertically on top of each other. The shapes are abstract and do not resemble any specific object or letter, giving the symbol a unique and potentially logo-like appearance. The background is plain white, which makes the pink symbol stand out prominently.
4. Performance Data
The Subject Device has been verified and validated according to Brainlab processes for product design and development. A high level explanation of the testing provided in this submission for the Subject Device is provided below.
Software verification
Software verification and validation testing has been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level.
Bench Tests
-
-RIGID BODY SURFACE MONITORING ACCURACY TEST:
As ExacTrac Dynamic 2.0 uses a new revision of the ETD 3D Camera A5060 (45401B) with a new LED, the accuracy of the surface based monitoring functionality of ExacTrac Dynamic 2.0 was checked using this new camera revision and an in-house phantom. The goal of the test was to prove the feasibility of the surface based patient monitoring of ExacTrac Dynamic 2.0 for use in radiotherapy. The quality assurance guidelines for nonradiographic radiotherapy localization and positioning systems, that were defined by AAPM Task Group 1472, shall be used as reference. -
। WORKFLOW & ACCURACY TEST EXACTRAC DYNAMIC:
This test is to verify that accuracy specifications for patient positioning and monitoring at phantom treatment with ExacTrac Dynamic are not affected by relevant conditions, settings and workflows. -
-RESPONSE TIME MEASUREMENT:
The test measures the time between phantom movement and the correspondingly created Beam-off signal. The time between phantom movement and the appearance of the "out of tolerance" signal on the monitor is tracked. -
-VERIFICATION OF THE RADIATION ISOCENTER CALIBRATION IN ETD 2.0:
This test is intended to demonstrate that the Radiation Isocenter Calibration in ETD 2.0 is not inferior to the previous, well-established Radiation Isocenter Calibration in ETD 1. * by more than a given threshold.
No clinical testing was required for the subject device.
5. Conclusion
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Image /page/10/Picture/0 description: The image shows a stylized, abstract symbol in a vibrant pink color. The symbol appears to be composed of three stacked elements, each resembling a curved or flowing shape, possibly inspired by calligraphy or a stylized letter. The overall design is compact and eye-catching, with a sense of movement and fluidity conveyed through the curved lines.
The comparison of the Subject Device with the predicate device shows that it has similar functionality, intended use and technological characteristics as the predicate device. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate device.