(191 days)
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
The Theratron 1000E 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 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.
This document is a 510(k) summary for the Theratron 1000E. It describes a medical device, a Cobalt Teletherapy unit used for cancer treatment. The document states that the device's development and validation comply with Theratronics product development procedures and that the validation demonstrates the device meets its published specifications and performs as well as or better than the predicate device (Theratron 1000).
However, the provided text does not contain the specific acceptance criteria, detailed results from a study proving these criteria were met, or most of the requested information about such studies. It is a summary statement of compliance for a 510(k) submission to the FDA, asserting that validation was done, but not describing the validation study itself in detail.
Therefore, I cannot fulfill most of your request directly from the given text.
Here's what I can provide based on the given information, and what is explicitly missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/Missing) | Reported Device Performance (Inferred/Missing) |
|---|---|
| Specific quantitative criteria are missing. The document generally states the device should: | The document states: "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." |
| - Deliver intended dose at specified position | - Device demonstrated to meet specifications. |
| - Deliver radiation according to selected relationship (fixed/moving beam, modifying device) | - Device demonstrated to meet specifications. |
| - Deliver radiation without unnecessary risk to patient, operator, others, or environment | - Device demonstrated to be safe and effective. |
| - Perform as well as or better than predicate device (Theratron 1000) | - Device demonstrated to perform as well or better. |
| - Have improved safety features | - Design includes "improved safety features." |
| - Have improved radiation shielding in collimator area | - Design includes "improved radiation shielding in the collimator area." |
Missing:
- Specific numerical or measurable acceptance criteria (e.g., dose accuracy within X%, leakage radiation below Y mSv/hr, specific safety interlock performance metrics).
- Quantitative results demonstrating the device actually met these criteria.
2. Sample size used for the test set and the data provenance
Missing: This information is not provided in the 510(k) summary. The document mentions "validation," but does not specify the sample size (e.g., number of units tested, number of measurement points) or the type of data (e.g., experimental data from a specific facility, clinical data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: This is not applicable in the context of this device, which is a Cobalt Teletherapy unit, not an AI/diagnostic device that typically uses expert ground truth for interpretation. For a physical device, "ground truth" would be established by physical measurements and engineering specifications, often against industry standards or regulatory limits.
4. Adjudication method for the test set
Missing: Not applicable for a physical device performance validation in the way it's used for AI/diagnostic studies.
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
Missing: Not applicable. This is a physical radiation therapy device, 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
Missing: Not applicable. This is a physical device, not an algorithm. Performance would be assessed based on its physical output (radiation dose, beam shaping, safety features).
7. The type of ground truth used
The "ground truth" for this device's performance would be:
- Engineering Specifications: The device's design specifications for dose delivery, beam characteristics, and safety interlocks.
- Regulatory Standards: Compliance with relevant national and international standards for medical electrical equipment and radiation safety.
- Predicate Device Performance: The established performance metrics of the legally marketed predicate device (Theratron 1000), which the new device aims to match or exceed.
Missing: The document does not explicitly detail these "ground truths," but rather asserts that the device meets its published specifications and performs as well as the predicate.
8. The sample size for the training set
Missing: Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Missing: Not applicable.
In summary: The provided text is a high-level regulatory summary for a medical device's 510(k) submission. It asserts compliance and substantial equivalence to a predicate device but does not contain the detailed study information (acceptance criteria, sample sizes, expert involvement, specific performance data) you requested. Such details would typically be found in the full design validation documentation or testing reports, which are not included here.
{0}------------------------------------------------
MAY 2 8 1997
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 1000E |
| Common name: | Cobalt Teletherapy device |
| Classification name: | Radionuclide Radiation Therapy System |
| Equivalent device: | Theratron 1000, 510(k) number K894165/B |
Description of device:
The Theratron 1000E 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 1000 with improved safety features and radiation shielding in the collimator area of the unit head assembly.
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 1000E 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.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three heads.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.MAY 28 1997
E. S. Martell Vice President Quality Assurance and Regulatory Affairs THERATRONICS International Limited 413 March Road P.O. Box 13140 Ontario, Canada K2K 2B7
Re: K964607
THERATRON T 1000E Cobalt Teletherapy Unit Dated: February 27, 1997 Received: March 3, 1997 Regulatory Class: II 21 CFR 892.5750/Procode: 90 IWD
Dear Mr. Martell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decembed 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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions sgainst misbranding 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 san 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 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 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Foderal 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 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 (2) CFR Part 801 and additionally 809.10 for in viter diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, 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,
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
{2}------------------------------------------------
Page 1 of _1
Number (if known): K964607
Device Name: THERATRON 1000E
Indications For Use: ¯
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.
1000
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Hegemann
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiclogical Devices
510(k) Number K96 4607
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.