(104 days)
RayCare is an oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below.
RayCare is a software-only system 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.
- Patient clinical data
- Care administration
- Clinical notes and documents
- Workflow and task management
- Charge capture
- Scheduling and calendar functions
- PACS
- Image viewer
- Simulation and imaging
- System administration
- Authentication, authorization and audit logging
- Hospital system integrations
The provided text is a 510(k) summary for the RayCare 3.1 device, an oncology information system. However, it does not contain specific acceptance criteria, performance metrics, or detailed study information that would allow a comprehensive answer to your request.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (RayCare 2.3) by highlighting similar technological characteristics and stating that verification and validation were performed according to relevant standards.
Therefore, I cannot provide a complete answer to your request based solely on the provided input.
However, I can extract the available information and indicate where details are missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states, "The summary of the performed non-clinical tests shows RayCare 3.1 is as safe and effective and performs as well as the predicate device." However, no specific metrics or thresholds are provided for "safe," "effective," or "performs as well." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the document.
- Data provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified in the document.
- Qualifications of experts: Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the document.
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
- MRMC study: Not specified in the document.
- Effect size: Not applicable, as no MRMC study or AI assistance is described. The device is an oncology information system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that verification and validation were done on the device's functionalities, but it does not detail specific "standalone" performance studies in the context of an algorithm's diagnostic or analytical capability. RayCare 3.1 is an information system, not primarily an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the document. The document refers to "intended use and functionalities included in a standard oncology information system" for its verification and validation, implying functional rather than diagnostic ground truth.
8. The sample size for the training set
- Not applicable/Not specified. This device is an oncology information system, not an AI/ML model that typically requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as it's not an AI/ML model with a typical training set.
Summary of what is available in the document regarding testing:
- Assessment of non-clinical performance data: "The verification and validation of RayCare 3.1 is based on the intended use and functionalities included in a standard oncology information system, and on the standards ISO 14971, IEC 61217, IEC 62304 and IEC 62366."
- Test conclusion: "The summary of the performed non-clinical tests shows RayCare 3.1 is as safe and effective and performs as well as the predicate device."
This document focuses on demonstrating substantial equivalence to an existing predicate device by showing that the new device has the same technological characteristics and has undergone standard verification and validation processes applicable to medical software. It does not contain the kind of detailed performance study data often found for AI/ML-driven diagnostic devices.
§ 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.