(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.
§ 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.