The NPTC is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.

Device Description

The equipment installed in the NPTC is comprised of the following two main components: (1) the beam delivery equipment and (2) the beam production equipment. The primary responsibility of the beam delivery equipment is to direct the proton beam to the patient's treatment site within the patient treatment location and to ensure that the patient critical functions are properly and safely carried out. The beam production equipment is necessary to produce the proton beam and direct it to the appropriate treatment room. In addition to the main components, the equipment in the NPTC also includes: (1) a Therapy Safety System ("TSS"); and (2) a computer-based Therapy Control System ("TCS").

AI/ML Overview

The provided text is a 510(k) summary for a medical device: the Northeast Proton Therapy Center (NPTC). This document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a clinical study evaluating the performance of a diagnostic or predictive algorithm.

Therefore, many of the requested categories (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set details) are not applicable or cannot be determined from this type of regulatory submission. This submission describes a treatment facility that produces and delivers a proton beam, not a diagnostic device that generates a "performance report" in the typical sense of AI/ML.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Intended Use/Technological Characteristics)	Reported Device Performance (from "Performance Data" and "Substantial Equivalence Discussion")
Create and direct (deliver) the proton beam appropriately to the patient treatment location.	Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers beam delivery).
Produce a transverse and longitudinal dose distribution appropriate for the patient treatment.	Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers dose distribution).
Deliver the designated dose to the patient's treatment site.	Performance testing conducted to demonstrate that the device meets its performance specifications. (Specific metrics not provided, but implicitly covers dose delivery).
Beam range similar to predicate Loma Linda facility.	The beam range in the NPTC facility is similar to the Loma Linda facility.
Safety and control systems are equivalent to predicate devices (Loma Linda and HCL).	The safety and control systems for the NPTC, Loma Linda, and HCL facilities are equivalent.
Engineering principles underlying accelerators are the same as predicate devices.	Even though the NPTC and its predicate devices use different accelerators, the engineering principles underlying their design are the same.

2. Sample size used for the test set and the data provenance:

Not Applicable. This is not a study of a diagnostic algorithm or a device that uses a "test set" in the traditional sense of AI/ML evaluation. The "performance data" refers to engineering and operational tests of the physical facility and beam, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2.

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

Not Applicable. See point 2.

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:

No. This is a proton therapy delivery system, not an AI-assisted diagnostic tool for human readers.

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

Not Applicable. This is a physical facility and its equipment for radiation therapy, not a standalone algorithm. The "performance data" would refer to the facility's ability to produce and deliver the proton beam as specified.

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

For the "performance data" mentioned, the ground truth would typically be engineering specifications, physical measurements, and industry standards for proton beam generation and delivery. For example, measurements of beam energy, intensity, shape, and dose distribution compared against design specifications.

8. The sample size for the training set:

Not Applicable. This device is a physical therapy center; it does not utilize a "training set" in the context of machine learning. The design and construction were based on established physics and engineering principles.

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

Not Applicable. See point 8.

Summary

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JUL 2 0 2001

983332

510(k) SUMMARY Massachusetts General Hospital Northeast Proton Therapy Center

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

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109

Phone: (202) 637-5794 Facsimile: (202) 637-5910

Contact Person: same as above

September 21, 1998 Date Prepared:

Name of Device and Name/Address of Sponsor

Northeast Proton Therapy Center

Massachusetts General Hospital Northeast Proton Therapy Center 30 Fruit Street Boston, MA 02114

Classification Name

Medical Charged-Particle Radiation Therapy System (21 C.F.R. § 892.5050)

Predicate Devices

Loma Linda University Medical Center's Proton Beam Therapy Center (1) (K872369)
Harvard University Cyclotron Laboratory's Proton Beam Therapy (2) Center (preamendments device)

Intended Use

The Northeast Proton Therapy Center ("NPTC") is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a

DC - 57171/5 - 0363497.07

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proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.

Technological Characteristics

Substantial Equivalence Discussion

The NPTC is substantially equivalent to both the Loma Linda (K872369) and the Harvard Cyclotron Laboratory proton therapy devices, the latter of which is a preamendments device. Like its predicate devices, the NPTC is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized tumors or other diseases that are susceptible to treatment by radiation.

The NPTC and its predicate devices provide the same or substantially equivalent functions, characteristics, and accessories as the NPTC. All of these devices are comprised of beam delivery systems that shape, direct, and monitor the protons delivered to the patient. They are also comprised of beam production equipment that generates the beam used by the beam delivery systems. All of the facilities include patient treatment rooms, but each has a different number of rooms.

The beam range in both the NPTC and Loma Linda facilities is similar. Even though the NPTC and its predicate devices use different accelerators. the engineering principles underlying their design are the same. The safety and control systems for the NPTC, Loma Linda, and HCL facilities are equivalent.

Although there are some differences between the NPTC and its predicate devices, these differences are minor and raise no new questions of safety and effectiveness.

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Performance Data

The submission includes performance testing that Massachusetts General Hospital conducted to demonstrate that the device meets its performance specifications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Massachusetts General Hospital % Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109 Re: K983332

Northeast Proton Therapy Center (Proton Therapy Center) Dated: June 4, 2001 Received: June 5, 2001 Regulatory Class: II 21 CFR 892.5050/Procode: 90 LHN

Dear Mr. Kahan:

Down has a market to a finent to market the device referenced above and we have deemning the We have reviewed your Section 5 (1){ } houtleation of much onclosure) to legally marketed prochisat devices
device is substantially equivalent (for the indications of the enc device is substantially equivalent (of the macantist to tas sation and the Medical Device Amendments, or to devices of to devices of to devices of to devices of to devices of marketed in interstate commerce prior of the Federal Food, Drug, and Comments Act (Act.). Tou may,
that have been reclassified in accordance with the provisions of the are that have been reclassified in accordance will the provisions of the reason on the provisions of the Act .
therefore, market the device, subject to the general controls provi therefore, market the device, subject of the general controls of the rear magazine of the ground of the mainst misbranding and adulteration.

If your device is classified (see above) into either class II (Premaket Approval), it may be subject If your device is classified (see above) into ellier coass of (optude control in the Code of Federal Regulations, to such additional controls. Existing major regulations arectives with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalent decembriation C Title 21, Parts 800 to 895. A substantialion (QS) for Medical Devices: General regulation (21 CFR Part
Practice requirements, as set forth in the Qualine (Device (DVA) Vecif Practice requirements, as set forth in the Qualified (40) for and Drup (402) will bently such assumptions. Failure
820) and that, through periodic QS inspections, the Food an 820) and that, through periodic QS inspections, the Programs Program Prohish further announcements
to comply with the GMP regulation may result in regulatory action. In acce to comply with the GMP regulation may result in regulations on more notification sumission doss not
concerning your device in the Federal Register. Please not of the Alectio concerning your device in the Federal Register. Ticase noter in the respections under the Electronic Product arroot any obtigations, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in the PDA finding for your device and This letter will allow you to begally marketing your device to real procession 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 Part 01 and additionally for questions on the promotions on the promotions on the promotions If you desire specific advice to your device of Compliance at (301) 584-4639. Additionally, for questions on the promotion diagnostic devices), please contact the Office of Compliation in (301) 594-4639. Also, please not the regulation of version of version on version on version on version on ve entitled, "Misbranding by reference to premarket notification". Other general information on your a entitled, "Misbranding by reterence to premaint notine of Sconel Manufactures assistance at its toll-free number (800)
responsibilities under the Act may be obtained from the responsibilities under the Act may be oblamed from the Drilston of Birlines of Suites
638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsma

Sincerely yours,

Nancy Crogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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510(k) Number (if known): 1 98 333 Z

Device Name:

Northeast Proton Therapy Center

Indications for Use:

The NPTC is a facility intended to produce and deliver a proton beam of known The NPTC is a factify intended to product of a patient. It is indicated for use in the energy, intensity and shape for treatment or a parcelor of I localized tumors or
therapeutic application of a proton beam for the treatment of the facility is ther diseases that are susceptible to treatment by radiation. The facility is
other diseases that are susceptible to treatment by proton heam other diseases that are susceptions to dreated direct (deliver) the proton beam designed so that it will. (1) create and includes a transverse and appropriately to the patient Libaton locator, (or process treatment; and (3) deliver
longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

Prescription Use	OR	Over-the-Counter Use
------------------	----	----------------------

(Per 21 C.F.R. 801.109)
(Optional Format 1-2-96)

Signature
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number .

\DC . 57171/5 . 0383487.08

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.