(203 days)
RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology.
For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course.
In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery.
RayCare is not intended for use in diagnostic activities.
RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology.
For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course.
In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery.
As an oncology information system, RayCare supports healthcare professionals in managing cancer care treatments. The system provides functionalities as described briefly in the sections below. These functionalities are not provided separately in different applications and have a joint purpose for the treatment of the patient.
RayCare is a software-as a Medical Device with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.
This document describes the premarket notification for RayCare (2024A SP1), an oncology information system. The relevant sections for acceptance criteria and study details are primarily found under "VII. Non-Clinical and/or Clinical Tests Summary" and the tables within it.
Based on the provided text, RayCare (2024A SP1) is not an AI/ML device in the sense of making autonomous diagnostic decisions or image-based classifications. It is an Oncology Information System that supports clinical workflows for radiation therapy and other oncology disciplines. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the software verification and validation (V&V) activities. Therefore, the information provided focuses on demonstrating the software's functional correctness, safety, and effectiveness compared to a predicate device, rather than performance metrics specifically for an AI model (e.g., sensitivity, specificity, AUC).
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Software V&V)
The acceptance criteria for RayCare (2024A SP1) are implicitly defined by the successful completion of various software verification and validation activities designed to demonstrate that the device performs as intended and is as safe and effective as its predicate. These are primarily functional and system-level criteria.
Table of Acceptance Criteria and Reported Device Performance:
Since this is a software verification and validation summary for an oncology information system, the "performance" is demonstrated through successful compliance with system specifications and validated functionality. The "acceptance criteria" are the "Pass criteria" of the specific tests.
| Acceptance Criteria (from "Criteria" or "Pass criteria" of listed V&V) | Reported Device Performance |
|---|---|
| Treatment Course Management (TCM) Workspace: The TCM workspace shall show the treatment course and its related series, treatment fractions, and assigned beam sets for the care plan selected in the global care plan selector. | |
| Specific criteria: | |
| • The treatment series related to the selected care plan is displayed. | |
| • The fractions in the fractions table are only related to the treatment series related to the selected care plan. | |
| • The assigned beam set table only displays the beam set related to the selected care plan. | Passed. "The successful validation of this feature demonstrates that the device is as safe and effective as the predicate device." |
| Extended RayCare Scripting Support (Unit Testing): Queries shall only be available for scripting if explicitly declared as scriptable (whitelisted data). | Passed. "The successful validation of this feature demonstrates that the device is as safe and effective as the predicate device." |
| Extended RayCare Scripting Support (System Level Verification): It is possible to run a script by clicking a RayCare script task, and the script has performed the expected action within RayCare. | Passed. "The successful validation of this feature demonstrates that the device is as safe and effective as the predicate device." |
| Offline and Online Recording of Treatment Results: Offline import is requested, received, and possible to sign with device and radiotherapy record selected for import for a selected session. | |
| Specific criteria: | |
| • Verify treatment course table and beam delivery result table in TC overview gets updated with corresponding data for the first session. | |
| • Verify the device selected for offline import is the delivered device on the session. | Passed. "The successful validation of this feature demonstrates that the device is as safe and effective as the predicate device." |
| Treatment Delivery Integration Framework (Varian TrueBeam): The treatment flow for treatment delivery is verified. | |
| Specific criteria: | |
| • The fraction is fully delivered, and the status of the fraction, session, and beams is set to "Delivered". | |
| • Compare the delivered meterset, the couch positions and angles. They should be the same. | |
| • The online couch corrections are calculated as the difference between the planned and the delivered couch positions. | Passed. "The successful validation of this feature demonstrates that the device is as safe and effective as the predicate device." |
Overall Conclusion:
"From the successful verification and validation activities, the conclusion can be drawn that RayCare 2024A SP1 has met specifications and is as safe, as effective and performs as well as or better than the legally marketed predicate device."
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of patient cases or images for evaluating an AI model. Instead, it refers to software verification and validation ("V&V") activities including unit testing, integration testing, system-level testing, cybersecurity testing, usability testing, and regression testing. These involve testing against requirements and specifications, often using simulated data, test cases, or specific user scenarios, rather than a fixed "dataset" of patient images.
- Data Provenance: The document does not explicitly state the country of origin of testing data or if it was retrospective or prospective. Given it's software V&V for an oncology information system, the "data" would primarily be test inputs and expected outputs generated internally during the development process (e.g., test scripts, simulated patient data to exercise specific functionalities). It's not a study on real patient data for diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable as this is a software verification and validation summary for an oncology information system, not a study evaluating an AI model's diagnostic or prognostic performance against expert-determined ground truth. The "ground truth" for V&V activities is the system's specified behavior and functional requirements. Software engineers and QA professionals establish whether the software meets these pre-defined requirements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies involving human readers to resolve discrepancies in annotations or diagnoses, especially when establishing ground truth for AI model evaluation. This document describes software V&V.
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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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No Clinical trials were required to demonstrate substantial equivalence."
- This type of study is relevant for AI-assisted diagnostic devices. RayCare is described as an oncology information system, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While the system has automated functions, the concept of "standalone performance" as it relates to an AI algorithm making a clinical decision (e.g., classifying a lesion) is not directly applicable here. The V&V described focuses on the system's ability to correctly manage and process information, integrate with other systems, and support user workflows, which are inherent to its "standalone" operation as an information system. The "performance" is demonstrated through successful execution of its intended software functions as per its specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the software verification and validation described here is the functional specifications and requirements of the RayCare system. Successful "verification" means the design output meets the requirements, and "validation" means the software conforms to user needs and intended uses. This is established through internal testing against defined expected behaviors.
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The sample size for the training set:
- Not applicable. RayCare (2024A SP1) is an oncology information system, and the document does not indicate that it incorporates a machine learning model that was "trained" on a dataset in the way an AI diagnostic or predictive algorithm would be. The device's "development" involved standard software engineering practices.
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How the ground truth for the training set was established:
- Not applicable. As there is no mention of an AI/ML training set, the concept of establishing ground truth for it does not apply.
In summary, this FDA review document pertains to the clearance of an Oncology Information System (OIS) through the 510(k) pathway, demonstrating substantial equivalence to a predicate device. The "acceptance criteria" and "proof" come from a robust set of software verification and validation activities (unit, integration, system, cybersecurity, usability, regression testing) rather than clinical studies or the evaluation of an AI model's diagnostic performance against a clinical ground truth. The device is not presented as an AI-driven diagnostic tool.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.