(263 days)
The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration.
The provided text describes a 510(k) premarket notification for a Medical Device, the "Real Time Image Gating System for Proton Beam Therapy Systems." While the document outlines performance tests conducted, it does not provide detailed acceptance criteria or the specific results of these tests in a quantitative manner that would allow for a complete table of acceptance criteria and reported performance.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and general safety/effectiveness. It lists the types of performance tests performed but lacks the specific metrics (e.g., "accuracy > 95%") and the outcome of those metrics.
Therefore, for aspects requested in the prompt that are not explicitly present in the provided text (e.g., exact acceptance criteria values, specific performance metrics, sample sizes for test/training sets, detailed ground truth establishment for training, number of experts, adjudication methods, MRMC study details), the answer will state that the information is not provided in the source document.
Here is a summary of the information available and what is missing based on your request:
Overview of Device Performance and Equivalence Study
The Real Time Image Gating System for Proton Beam Therapy Systems is designed to generate gating signals to deliver a proton beam when the position of an implanted fiducial marker (tracked by X-ray fluoroscopy) is within a given tolerance from its planned position. The system uses pattern recognition technology to automatically extract the marker's location and calculates its spatial position in 3D throughout treatment.
The performance data presented in the 510(k) summary aims to establish substantial equivalence to predicate devices (MedCom GmbH's Verisuite and Elekta Ltd.'s XVI R5.0). The study was conducted by Hitachi, Ltd. Healthcare.
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not explicitly list quantitative acceptance criteria or specific reported device performance values for the tests conducted. It only lists the types of tests performed.
| Criterion Type (e.g., Accuracy, Latency) | Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|---|
| Recognition accuracy of static fiducial | Not specified | Not specified |
| System latency | Not specified | Not specified |
| Tracking of moving marker | Not specified | Not specified |
| Dose measurement of fluoroscopic X-ray | Not specified | Not specified |
| Interlock interface testing | Not specified | Not specified |
| Interplay effect | Not specified | Not specified |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for any of the performance tests (e.g., number of images, number of instances of fiducial tracking, or number of patients/phantoms).
- Data Provenance (e.g., country of origin, retrospective/prospective): The document does not explicitly state the country of origin for the data used in the performance tests. The submitter is Hitachi Ltd. Healthcare in Japan. It also does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify if human experts were involved in establishing ground truth for the performance tests, nor does it mention the number or qualifications of any such experts. The system uses "pattern recognition technology" to automatically extract marker positions.
4. Adjudication Method for the Test Set
As there is no mention of human expert involvement in ground truth establishment for the test set, an adjudication method (e.g., 2+1, 3+1) is not applicable or not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
An MRMC study was not conducted or described in this 510(k) submission. The performance tests appear to be focused on the device's technical specifications and functionality, not a comparison of human reader performance with and without AI assistance. Therefore, an effect size of human reader improvement with AI assistance cannot be determined from this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The performance tests described (Recognition accuracy of a static fiducial marker, System latency, Tracking of moving marker, etc.) appear to be standalone assessments of the device's technical capabilities, without human intervention as part of the primary performance evaluation. The device is described as an "accessory" that processes images and sends timing signals automatically.
7. The Type of Ground Truth Used
The document implies that the ground truth for "recognition accuracy of a static fiducial marker" and "tracking of moving marker" would be based on the known, controlled, or planned positions of the fiducial markers (e.g., in a phantom or controlled experimental setup). It does not mention expert consensus, pathology, or outcomes data as sources for ground truth in these specific performance tests. The system itself "recognizes the position" and "tracks the implanted marker," suggesting a comparison against a known physical position.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of detail is typically not required for a 510(k) submission focused on substantial equivalence where the device's core technology (pattern recognition) is presumed to be developed prior to the specific product's submission.
9. How the Ground Truth for the Training Set Was Established
Since no information about a training set is provided, how its ground truth was established is also not described in the document.
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December 26, 2017
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Hitachi, Ltd. Healthcare % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street. NW WASHINGTON DC 20016
Re: K171049
Trade/Device Name: Real Time Image Gating System for Proton Beam Therapy Systems Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2017 Received: December 1, 2017
Dear Mr. Kahan:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K171049
Device Name
Real Time Image Gating System for Proton Beam Therapy Systems Indications for Use (Describe)
The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Hitachi Ltd.'s Real Time Image Gating System
Submitter
Hitachi Ltd. Healthcare Hitachi Works 3-1-1, Saiwai-cho, Hitachi-shi lbaraki, JAPAN 317-8511
Phone: +81-294-555232 Facsimile: +81-294-559946
Contact Person: Tomoyuki Seino Date Prepared: April 7, 2017
Name of Device:
Real Time Image Gating System for Proton Beam Therapy Systems
Common or Usual Name:
System, radiation therapy, charged-particle, medical
Classification Name:
Medical charged-particle radiation therapy system (21 CFR 892.5050)
Regulatory Class:
Class II
Product Code:
LHN
Predicate Devices
K133914 MedCom GmbH's Verisuite K131965 Elekta Ltd.'s XVI R5.0
Reference Devices
K160432 Anzai Medical's AZ-733VI
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Device Description
The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller.
This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration.
Intended Use / Indications for Use
The Real-time Image Gating System is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
Summary of Technological Characteristics
The RGS is a software-based accessory installed in the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. Similarly, the Verisuite and XVI predicates use software-based image processing systems for verification.
This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the fluoroscopic X-ray imaging systems of the PBTS. Similarly, the Verisuite and XVI use fluoroscopic X-ray during treatment to identify implanted fiducial markers.
Although neither the XVI nor the Verisuite includes a gating functionality, each can be used with separately-controlled gating system. Although the inclusion of the gating functionality could impact the safety or effectiveness of the device, it does not raise new questions of safety or effectiveness. In addition, other legally-marketed devices with respiratory gating systems have been cleared by the agency to control the delivery of radiation therapy, including Anzai Medical's AZ-733VI respiratory gating system (K160432). The gating of the proton beam is an
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additional safety feature of the RGS that reduces proton beam exposure to areas outside of the target treatment area
Performance Data
The following tests were performed to establish equivalence of the Real Time Gating System:
- . Dose measurement of fluoroscopic X-ray at the isocenter and skin surface position on the X-ray tube side
- Recognition accuracy of a static fiducial marker .
- System latency
- . Tracking of moving marker
- Interlock interface testing ●
- Interplay effect ●
Conclusions
The Real Time Gating System is as safe and effective as the VeriSuite and XVI devices. The Real Time Gating System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Real Time Gating System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Real Time Gating System is as safe and effective as the predicate devices. Thus, the Real Time Gating System is substantially equivalent.
§ 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.