The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Device Description

The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

The beam delivery system is composed of the following components:

Gantry Room
- Rotating Gantry
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT / X-ray Imaging System
Fixed Beam Room
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT

The beam production system is composed of the following components:

Accelerator system (LINAC, Synchrotron)
Beam transport system (Low/High Energy Beam Transport systems)

AI/ML Overview

The provided text is a 510(k) summary for the PROBEAT-V proton beam therapy system. It describes the device, its intended use, and performance data. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and a study proving the device meets those criteria, particularly regarding AI performance, expert ground truth, sample sizes for training/test sets, and adjudication methods, as this is neither an AI device nor does it have relevant information about AI device testing.

Here's a breakdown of what can be extracted from the document:

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

The document provides a general statement about performance testing without specific quantitative acceptance criteria. It broadly states that the device "functioned as intended and met its specifications."

Acceptance Criteria (Stated broadly)	Reported Device Performance
Mechanical performance of rotating gantry and patient couch	Functioned as intended and met specifications
Beam dose shape and beam dose	Functioned as intended and met specifications
Beam stop control, dose monitor, area safety, and mechanical interlocks	Functioned as intended and met specifications
Electrical safety (IEC 60601-1)	Met specifications
Electromagnetic compatibility (IEC 60601-1-2)	Met specifications

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

This information is not provided in the document. The document describes general performance testing but does not specify sample sizes or data provenance.

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)

This information is not applicable/provided. The PROBEAT-V is a therapeutic device (proton beam therapy system), not a diagnostic or AI-driven decision support system that typically requires expert-established ground truth for image interpretation or diagnosis. The performance testing focuses on the physical and functional aspects of the hardware and beam delivery.

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

This information is not applicable/provided for the same reasons as the previous point. Adjudication methods are typically used in studies involving subjective assessments or classifications by human readers, which is not the nature of the described performance testing for a proton beam therapy system.

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

There is no indication that an MRMC comparative effectiveness study was done, nor is AI assistance mentioned. The device is a proton beam therapy system, not an AI-driven image analysis or decision support tool.

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

This information is not applicable/provided. The PROBEAT-V is a physical medical device for radiation therapy, not an algorithm. Its performance testing relates to its mechanical, electrical, and beam delivery functionalities.

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

The concept of "ground truth" as typically applied to diagnostic studies (e.g., pathology for a tumor diagnosis) is not directly applicable here. The performance testing described (mechanical, beam, safety interfaces, electrical safety, EMC) likely uses objective, measurable physical parameters and engineering standards as its "ground truth" or reference for meeting specifications. For example, a "beam dose shape" would be compared against a pre-defined expected profile, or electrical safety against a standard like IEC 60601-1.

8. The sample size for the training set

This information is not applicable/provided. The PROBEAT-V is a hardware medical device; it does not involve a "training set" in the context of machine learning. Its design and manufacturing are based on engineering principles and established medical device standards.

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

This information is not applicable/provided for the same reasons as the previous point.

Summary

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

November 2, 2015

Hitachi, Ltd., Health Care Company % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016

Re: K152592

Trade/Device Name: PROBEAT-V Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: September 10, 2015 Received: September 10, 2015

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'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)

K152592 Device Name

PROBEAT-V Indications for Use (Describe)

The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

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 PROBEAT-V

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hitachi, Ltd., Health Care Company 4-14-1 Sotokanda, Chiyodaku, Tokyo, 101-8010, Japan Telephone: +81 (3) 45643563 Facsimile: +81 (3) 45642882

Contact Person: Naoya Nishimura

Date Prepared: September 10, 2015

Name of Device and Name/Address of Sponsor

PROBEAT-V Proton Beam Therapy System

Hitachi, Ltd. Power Systems Company 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan

Common or Usual Name

Proton beam therapy system

Classification Name

Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN

Predicate Devices

Hitachi Ltd. PROBEAT with Discrete Spot Scanning System (K073059)

Hitachi Ltd. PROBEAT-V (K151132)

Intended Use / Indications for Use

The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

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Technological Characteristics

The beam delivery system is composed of the following components"

o Gantry Room
- . Rotating Gantry
- . Scanning Nozzle
- . Patient Positioning System
- . Cone Beam CT / X-ray Imaging System
o Fixed Beam Room
- Scanning Nozzle
- . Patient Positioning System
- . Cone Beam CT

The beam production system is composed of the following components"

Accelerator system (LINAC, Synchrotron) o
Beam transport system (Low/High Energy Beam Transport systems) о

Performance Data

The company performed testing, as follows:

The mechanical performance of the rotating gantry and patient couch O
Beam performance testing to evaluate beam dose shape and beam dose O
Safety interface testing to evaluate beam stop control, dose monitor, area safety, O and mechanical interlocks.

Further, electrical safety and electromagnetic compatibility testing was also performed in accordance with IEC 60601-1 and IEC 60601-1-2.

In all instances, the PROBEAT-V functioned as intended and met its specifications.

Substantial Equivalence

The PROBEAT-V has the same intended use and indications for use, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT with DSSS (K073059) and a previously cleared version of the PROBEAT-V (K151132). Each of the systems comprises the same components of the beam production and beam delivery subsystems. The minor differences between the PROBEAT-V that is the

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subject of this submission and the cleared PROBEAT and PROBEAT-V do not raise different questions of safety or effectiveness. Thus, the PROBEAT-V is substantially equivalent to its predicate devices.

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.