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 Elite consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate devices Theratron 780E and 1000E. The key difference is that the 'push-button' style control console on the predicate devices has been replaced with a modern PC based remote control console with graphic user interface and 'Record and Verify' communication capability.

AI/ML Overview

The provided text describes a medical device, the Theratron Elite, which is a Cobalt Teletherapy device. The 510(k) summary indicates that the device's development and validation are in compliance with Theratronics product development procedures and that the validation demonstrates the device meets its published specifications.

However, the provided documentation does not contain specific acceptance criteria values or detailed results from a study proving these criteria were met. It only states a general conclusion that the device performs "as well or better than the predicate device."

Therefore, I cannot populate sections 1 through 9 of your request with specific numbers or detailed methodological descriptions because the information is not present in the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated with quantifiable thresholds. The summary mentions "published specifications" but does not detail them.
Reported Device Performance: Not explicitly stated with quantifiable metrics. The summary states it "performs as well or better than the predicate device" (Theratron 780E and 1000E).

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

Sample Size: Not mentioned.
Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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

Not applicable as no specific test set or ground truth establishment process is described for performance evaluation.

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

Not applicable as no specific test set or ground truth establishment process is described for performance evaluation.

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:

Not applicable. This is a Cobalt Teletherapy device, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers." The primary comparison is to a predicate device's technical specifications and performance in delivering radiation, not human reading performance.

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

This question is more relevant to AI-driven diagnostic tools. For a radiation therapy device, the performance is inherently "standalone" in terms of its mechanical and radiation delivery capabilities. The device's "performance" would be related to accuracy of dose delivery, beam shaping, and safety controls, which would be tested without human "interpretation" in the loop beyond operational controls. The text mentions "development and validation" but doesn't detail the studies.

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

Not applicable in the context of diagnostic interpretation. For a radiation therapy device, "ground truth" would relate to manufacturing specifications, radiation physics parameters, safety standards, and potentially clinical outcomes if a clinical trial were conducted. The document states "device meets its published specifications," implying engineering and physics testing against known standards.

8. The sample size for the training set:

Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.

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

Not applicable as this is not an AI/machine learning device.

Conclusion based on the provided text:

The 510(k) summary for the Theratron Elite primarily focuses on establishing substantial equivalence to predicate devices (Theratron 780E and 1000E) based on its design, intended use, and general performance claims. It states that "The validation demonstrates 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." However, it does not provide the specific data, metrics, or detailed study methodology that would allow for a comprehensive answer to your questions regarding acceptance criteria and performance study details.

Summary

{0}------------------------------------------------

Theratron Elite 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 & Regulatory Affairs
Date:	Nov 16, 1998
Trade name:	Theratron Elite
Common name:	Cobalt Teletherapy device
Classif. name:	Radionuclide Radiation Therapy System
Equivalent device:	Theratron 780E (K964606), Theratron 1000E (K964607)

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 Section 2.

Summary of conclusions drawn from nonclinical tests

The Theratron Elite development and validation is in compliance with Theratronics product development procedures. The validation demonstrates 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.

{1}------------------------------------------------

Image /page/1/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three heads, arranged in a vertical stack. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.

1000 4 DEC

E.S. Martell Vice President Quality and Regulatory Affairs Theratronics International, Ltd. 413 March Road Kanata, Ontario CANADA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983917 Theratron Elite 80 and 100 Dated: October 29, 1998 Received: November 4, 1998 Regulatory class: II Procode: 90 IWB CFR 892.5750

Dear Mr. Martell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 either class II (Special Controls) or 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 Federal Regulations, 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 assumptions. Failure to comply 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 submission 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 device as described in your 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 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 594-4613 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 at (301) 443-6597.

Sincerely yours,

Willian Yin
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

{2}------------------------------------------------

Intended use of device 3.

The device is intended to be used in:

Delivering the intended dose of radiation 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.

Vinid C. Flynn

sion Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109)__ and the image.

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.