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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.

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.

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.

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THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.

THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below.

Hardware platform and Operating System: Pentium PC, Windows NT

Peripherals and accessories: Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi.

Main software features:
Unit Modelling of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators.
Source Modelling of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life.
Patient Data Acquisition by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units.
Anatomy Modelling to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning.
Brachytherapy Planning may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Timedomain calculations may also be performed based on the pattern of sources and their halflives.
External Beam Planning may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled.

The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.

The provided text for the THERAPLAN Plus Version 1.2 510(k) submission describes the device, its features, and intended use, and concludes that its development and validation are in compliance with Theratronics product development procedures. These procedures reportedly ensure that system testing and validation demonstrate that the system meets its published specifications, performs as well as or better than predicate products, and is safe and effective for its intended use.

However, the provided document does not explicitly state specific acceptance criteria (metrics with numerical thresholds) or detail a standalone study that directly proves the device meets these criteria. The text primarily focuses on describing the device's functionality and its substantial equivalence to predicate devices. The "Conclusion" section makes a general statement about meeting specifications and performing comparably to predicate devices, but lacks the specific data requested regarding acceptance criteria and a dedicated study to prove it.

Therefore, the following information is not explicitly available in the provided text:

• A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are listed, nor are numerical results presented against such criteria.
• Sample size used for the test set and the data provenance: No information about a specific test set, its size, or its origin (e.g., country, retrospective/prospective) is provided for a performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details are given about how ground truth was established for any test data.
• Adjudication method for the test set: No adjudication method is mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a "Radiation Therapy Treatment Planning System" which assists healthcare professionals, but it's not an AI specifically designed to improve human reader performance in a diagnostic sense.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document does not describe a standalone performance study. The device is intended to be used by healthcare professionals.
• The type of ground truth used: No specific type of ground truth (e.g., pathology, outcomes data) is mentioned for any performance evaluation.
• The sample size for the training set: No information regarding a training set or its size is provided.
• How the ground truth for the training set was established: No information regarding ground truth establishment for a training set is provided.

Based on the provided text, the THERAPLAN Plus Version 1.2 is a "Radiation Therapy Treatment Planning System." Its validation focused on compliance with Theratronics product development procedures, aiming to ensure it meets published specifications and performs as well as or better than predicate products. However, the document does not furnish the specific details of a performance study demonstrating quantitative acceptance criteria.

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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.

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.

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.

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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

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.

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Ask a specific question about this device