(53 days)
MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:
- · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
- · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
- · Import, view, annotate, adjust, enhance, manage and archive images.
- · Compare radiation treatment plans and evaluate dose coverage.
- Design leaf plans for operation with radiotherapy treatment machines that have multi-leaf collimators.
- · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.
- · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup and communicates patient and machine setup instructions.
- · Record actual delivered radiation values in an electronic chart to track treatment.
- · Use stereotactic localization to calculate set-up coordinates for treatments.
- · Monitor Intrafractional motion with real time image overlay.
MOSAIQ® is not intended for use in diagnosis.
The MOSAIQ® Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilitates efficient patient care. It can be configured for Medical Oncology, Radiation Oncology, or both.
The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointments. Configurable flowsheet views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and screen for drug/drug and drug/allergy interactions. MOSAIQ also performs standard calculations such as Body Surface Area (BSA) and Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple sites of administration, etc. MOSAIQ's Medical Oncology functions are designed for adult patient care. It is labeled accordingly and calculates all doses accordingly.
The Radiation Oncology configuration is also a charting solution with Computerized Physician Order Entry (CPOE) capability, along with added features for image management, patient setup and positioning, verify and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAIQ's Radiation Oncology functionality can be used to support a wide variety of treatment modalities including Intensity Modulated Radio Therapy (IMRT), Image Guided Radio Therapy (IGRT), particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from Therapy Planning Systems (TPS) via DICOM import/DICOM RT import.
The provided text is a 510(k) summary for the MOSAIQ® Oncology Information System. It details the device's intended use, comparison to a predicate device, and non-clinical performance data. However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop study with specific metrics like sensitivity, specificity, or reader improvement.
The document states:
- "Verification and Validation testing was performed ensure that the system is working as designed. A significant number of test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. MOSAIQ passed testing and was deemed safe and effective for its intended use and well as meeting identified user needs."
This is a general statement about V&V testing but lacks the specifics required for your request. The device is primarily an Oncology Information System designed to manage workflows, calculate dosages, manage images, compare treatment plans, and perform pre-treatment checks and record-keeping, rather than an AI-driven diagnostic or image-interpretation device where metrics like sensitivity, specificity, and human reader improvement are typically reported.
Therefore, many of the specific questions you asked cannot be answered directly from the provided text as the information is not present. Based on the document, I can infer some points and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with specific quantitative metrics (e.g., sensitivity, specificity, AUC) for the system's performance, nor does it report such detailed performance. It generally states that "MOSAIQ passed testing and was deemed safe and effective for its intended use and well as meeting identified user needs."
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| Not specified in document | Not specified in document |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "a significant number of test procedures" but no specific sample size for any test set (e.g., number of test cases, patient records, or images).
- Data Provenance: Not specified. It's unclear if data for testing was retrospective or prospective, or its country of origin.
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. The document does not describe the use of experts to establish a "ground truth" for a test set, as would be typical for image-analysis AI devices. The system's functions (workflow management, calculations, data comparison) suggest different validation methods.
4. Adjudication Method for Test Set:
- Not specified. This is typically relevant for expert-driven ground truth establishment, which is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No evidence. The document does not describe an MRMC study comparing human readers with and without AI assistance. The MOSAIQ system's primary function is an information system, not an AI for image interpretation or diagnosis that would typically warrant such a study for its core functionality.
6. Standalone (Algorithm Only) Performance:
- Not specified directly in quantitative terms. The document states "Verification and Validation testing was performed ensure that the system is working as designed" including "tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests." This implies testing the functionality of the algorithms/software, but specific standalone performance metrics (e.g., for an automated diagnostic task) are not provided.
7. Type of Ground Truth Used:
- The concept of "ground truth" as typically used for AI diagnostics (e.g., pathology, outcomes data) is not explicitly detailed. For an oncology information system, "ground truth" would likely refer to the correctness of calculations, data integration, workflow execution, warnings, and record-keeping accuracy as per predefined rules and specifications, rather than clinical outcomes or expert consensus on image findings.
8. Sample Size for Training Set:
- Not specified. The document does not mention a "training set" as it would for a machine learning model, further indicating that the clearance is not for an AI / ML diagnostic device in the traditional sense that generates a model from data.
9. How Ground Truth for Training Set Was Established:
- Not applicable as no "training set" is mentioned in the context of machine learning. The "ground truth" in the context of this device's development would be its design specifications and user requirements, against which its functions are validated.
In summary: The provided document is for an Oncology Information System (MOSAIQ) which is primarily a data management and workflow system, not an AI-powered diagnostic tool. Therefore, the types of performance data (e.g., sensitivity, specificity, MRMC studies, AI training/test sets) commonly associated with AI/ML medical devices are not present in this 510(k) summary. The acceptance criteria and performance data are described in general terms of meeting design specifications and ensuring safety and effectiveness through software verification and validation.
§ 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.