A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the A Cobalt Teletherapy and is a do not of health care professionals in a radiation therapy clinic.

The unit is intended to be used in:

delivering the intended dose at a specified position; .
delivering the radiation in accordance with the selected relationship of the radiation to the . patient (fixed or moving beam therapy, beam modifying device, etc.);
. delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

Device Description

The Theratron 780E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 780C with improved safety features and radiation shielding in the collimator area of the unit head assembly.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Theratron 780E, a Cobalt Teletherapy device. The submission focuses on demonstrating substantial equivalence to a predicate device (Theratron 780C) and mentions general compliance with product development procedures.

However, the document does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, ground truth establishment, or sample sizes for an AI/device performance study. The provided text is a regulatory summary and approval letter, not a clinical or performance evaluation report.

Based on the provided text, I can only state that:

No acceptance criteria or device performance table is provided. The document states "The validation demontrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use," but no specific metrics or targets are given.
No specific study is described that details how the device meets acceptance criteria. The document refers to "Theratronics product development procedures" and "validation" but does not provide details on study design, sample sizes, or data provenance.
The document does not describe a test set, training set, or how ground truth was established.
There is no mention of experts, adjudication methods, MRMC studies, or standalone performance.
The device description and intended use indicate this is a hardware device (radiation therapy system), not an AI/software device that would typically undergo the type of performance evaluation you are asking about. The questions you've posed (e.g., sample size for test set, number of experts, MRMC, standalone performance, training set size) are highly relevant for AI/machine learning medical devices, but not for a device like the Theratron 780E, which is a physical radiation therapy unit.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The information is simply not present in this regulatory submission.

Summary

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JUN 26 1997

K9644606

Appendix 2 510(k) Summary

Submitter:	Theratronics International Limited413 March Road, P.O. Box 13140Kanata, OntarioCanada K2K 2B7
Phone:	613-591-2100
Fax:	613-592-3816
Contact person:	E. S. Martell, Vice President Quality Assurance & RegulatoryAffairs
Date:	October 21, 1996
Trade name:	Theratron 780E
Common name:	Cobalt Teletherapy device
Classification name:	Radionuclide Radiation Therapy System
Equivalent device:	Theratron 780C, 510(k) number K850543.

Description of device:

Intended use of device:

The unit is intended to be used in:

delivering the intended dose at a specified position; .
delivering the radiation in accordance with the selected relationship of the radiation to the . patient (fixed or moving beam therapy, beam modifying device, etc.);
. delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

Summary of comparison to predicate device.

See Appendix 5.

Summary of conclusions drawn from nonclinical tests

The Theratron 780E development and validation is in compliance with Theratronics product development procedures. The validation demontrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use.

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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image and is the only element in the image. The text is likely part of a document or presentation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1997

M.S. Martell Vice President Quality Assurance and Regulatory Affairs Theratronics Intl., Ltd. 413 March Road - ...... P.O. Box 13140 Kanata Ontario, K2K 2b7

Re: K964606

Theratron 780E Radionclide Radiation Therapy System Dated: June 2, 1997 Received: June 4, 1997 Regulatory class: II ...... 21 CFR 892.5750/Procode: 90 IWB

Dear Mr. Martell:

We have reviewed your Section 510(x) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for anuval registration, listing of devices, good manufacturing practice, labeling, and prohibitions and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feculations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note, this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-613 for Ear. Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
William Y

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of _1

Number (if known): K964606

Device Name: THERATRON 780E

Indications For Use:... . ... ......... . . . . . . . . .

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the A Cobalt Teletherapy and is a do not of health care professionals in a radiation therapy clinic.

(Please do not write Below This Line - Continue on another Page if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Flynn
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiologicai Devices 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.