ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Device Description

ExacTrac is a patient positioning and monitoring system providing the following main features: Patient positioning based on comparison between ExacTrac acquired X-ray images and calculated DRR (Digital Reconstructed Radiographs) using data provided by a treatment planning system. Patient positioning based on comparison between a CBCT scan, acquired by a 30 Imaging Device and imported into ExacTrac, and CT data provided by a treatment planning system. Both modalities can be based on: anatomical landmarks or implanted markers. Patient monitoring during treatment.

AI/ML Overview

The provided text doesn't explicitly state quantitative acceptance criteria or a specific study that proves the device meets them with performance metrics. It rather discusses the general clinical evaluation methods used to support the substantial equivalence decision for the ExacTrac system. However, I can extract and organize the available information relevant to your request.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific accuracy thresholds) or corresponding reported device performance values. The clinical evaluation focuses on supporting "substantial equivalence."

Study Information

The document describes the methods used for clinical evaluation rather than a single, detailed study with specific results.

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the given text. The document focuses on general methods of clinical evaluation rather than specific numerical acceptance criteria and performance outcomes.
Sample Size Used for the Test Set and Data Provenance:
- Test Set (Implicit):
  - For X-ray images: "Analysis of existing x-ray image datasets acquired with ExacTrac 5.5 during routine clinical use." No specific sample size is given.
  - For CBCT datasets: "Analysis of existing CBCT datasets during routine clinical use for retrospective clinical study." No specific sample size is given.
- Data Provenance: The data comes from "routine clinical use," implying it is retrospective and likely from various clinical sites using ExacTrac 5.5. The country of origin is not specified but given the manufacturer (Brainlab AG, Germany), it's plausible the data could be international, including European and potentially US data.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: This information is not provided in the text. The document does not detail how ground truth was established for the "existing x-ray image datasets" or "existing CBCT datasets."
Adjudication Method for the Test Set: This information is not provided in the text.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication of an MRMC comparative effectiveness study being performed to assess the effect size of human readers improving with AI vs. without AI assistance. The ExacTrac device is a patient positioning and monitoring system, not primarily an AI-driven diagnostic or interpretation tool that directly assists human readers in making diagnoses.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study: The document describes "Patient positioning based on comparison between ExacTrac acquired X-ray images and calculated DRR" and "Patient positioning based on comparison between a CBCT scan... and CT data." This implies the system (algorithm) performs an alignment task. While these are standalone functions of the algorithm, the text does not quantify or provide the results of a specific standalone performance study in terms of accuracy metrics. The clinical evaluation mentions "Simulated treatment of anthropomorphic human-bone phantoms," which would involve standalone system performance, but again, no quantitative results are given.
Type of Ground Truth Used:
- For the "Simulated treatment of anthropomorphic human-bone phantoms": The phantom's known anatomical landmarks or implanted markers would serve as a form of ground truth, established by the phantom's design and potentially precise measurements.
- For the "Analysis of existing x-ray image datasets" and "existing CBCT datasets": The text doesn't explicitly state the ground truth establishment method. It's likely that ground truth for alignment tasks would be based on:
  - Comparison to calculated DRRs or CT data: The "Indication for use" and "Device description" mention comparing acquired images to DRRs/CT data from a treatment planning system. The treatment planning system's calculated (expected) positions might serve as the reference.
  - Anatomical landmarks or implanted markers: The device description explicitly states both modalities can be based on these, which would inherently provide a ground truth for positioning.
Sample Size for the Training Set: This information is not provided in the text. As ExacTrac is a patient positioning system leveraging image comparison and potentially markers, it's not described as a deep learning or AI system that requires a distinct "training set" in the modern sense. It uses existing image data (DRRs, CTs) and acquired images for comparison.
How the Ground Truth for the Training Set Was Established: This information is not applicable in the context of the provided text, as a specific "training set" for an AI model is not mentioned. The device's operation is based on comparing acquired patient images to reference images (DRRs, CTs) from a treatment planning system, where the ground truth is implicitly defined by the initial treatment plan or the known positions of markers/anatomy in those reference images.

Summary

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510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR EXACTRAC

AUG 1 4 2012 Manufacturer: Brainlab AG Kapellenstrasse 12 85622 Feldkirchen Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33 Submitter: Rainer Birkenbach Contact person: Alexander Schwiersch June 11, 2012 Summary date: Device: ExacTrac ExacTrac® X-Ray, ExacTrac® Infrared Monitoring, ExacTrac® IGRT, Trade name: ExacTrac® Snap Verification, ExacTrac® Room-based IGRT, ExacTrac® CBCT Alignment Common/Classification Patient Positioning System with respiratory Gating, Radiation Therapy, Name: Charged-Particle, Medical ExacTrac 5.5 (K072506) Predicate Device: Varian On-Board Imager Device (K042720) Device classification System, Radiation Therapy, Charged-Particle, Medical name: Regulatory Class: Class II Regulation Number: 21 CFR 892.5050 Product Code: IYE ExacTrac is intended to be used to place patients at an accurately defined Indication for use point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also,be used to monitor the patient position during the treatment. ExacTrac is a patient positioning and monitoring system providing the Device description: following main features: Patient positioning based on comparison between ExacTrac acquired . X-ray images and calculated DRR (Digital Reconstructed Radiographs) using data provided by a treatment planning system. Patient positioning based on comparison between a CBCT scan, . acquired by a 30 Imaging Device and imported into ExacTrac, and CT data provided by a treatment planning system.

. Both modalities can be based on:
- anatomical landmarks 0
  - implanted markers 0
Patient monitoring during treatment .

FORM 04-195

REVISION 3

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margins i.e. 4x or 8x its weight

Heat resistance tests to make sure that the material does not change due . to a change in temperature e.g. as a result of sterilization
. Biocompatibility tests
Prototyping
EMC testing in accredited laboratory .

Statement of the clinical test:

For the Clinical Evaluation the following validation methods and data sources have been used:

� Literature review
. Simulated treatment of anthropomorphic human-bone phantoms within a real clinical environment
. Analysis of existing x-ray image datasets acquired with ExacTrac 5.5 during routine clinical use
. Analysis of existing CBCT datasets during routine clinical use for retrospective clinical study.

Application performance testing

On different levels of development (module, subsystem, system) specific bench and integration tests were conducted. Internal standards were tested and documented as conformance report, environment compatibility and interfaces. Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols.

Conclusions

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Alexander Schwiersch Regulatory Affairs Manager BrainLab AG R&D Radiosurgery Kapellenstrabe 12 FELDKIRCHEN BAVARIA 85622 GERMANY

AUG 1 4 2012

Re: K120789

Trade/Device Name: ExacTrac Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 12, 2012 Received: June 18, 2012

Dear Mr. Schwiersch:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the . Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number (if known):

K120789

Device name: ExacTrac

Indication for use:

Prescription Use (Per 21 CFR 801 Subpart D). AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Radiological Devices
510k K120789

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.