(50 days)
MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users:
- Supply electronic patient charts and assemble care plans, order diagnostic . tests, and prescribe medications.
- Import, view, annotate, manipulate, enhance, and archive images. .
- Import, keep, and export information related to patient treatments to ● monitor treatment progress from a central location. This includes orders, documents, lab information, and other related information from compatible programs.
- Generate and keep medication and formulary lists and calculate applicable . medication dosages for medical oncology.
- Design leaf plans for operation with radiotherapy treatment machines that . have multileaf collimators. Users can give, view and change geometric data related to treatment fields, including the MLC accessory.
- Ensure plans imported from treatment planning systems agree with . treatment machine constraints.
Additionally, MOSAIQ: - . Supplies other administrative functionality necessary to operate medical and radiation oncology departments.
- . Shows reference images for setup purposes, refers to predefined settings to help treatment machine setup, and tells clinicians of necessary steps before treatment.
- Reads actual settings from the treatment machine through the machine's ● communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system inhibits treatment.
- . Verifies the actual treatment against radiation treatment plans. At applicable points during the treatment, it records the actual delivered values to provide treatment tracking.
MOSAIQ supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. MOSAIQ is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users. MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery.
Previously, three of the components within MOSAIQ were cleared through the 510(k) process individually. The ViewStation software (K011694) provides the ability to to import, view, annotate, manipulate, enhance, manage and archive medical images and includes patient positioning functionality. The MLC Fit software (K991133) allows users to define MLC leaf shapes for radiation treatment plans. The SEQUENCER software (K981313) connects to the treatment unit (e.g. linear accelerator) and compares its setup to the predefined treatment field in the treatment chart. SEOUENCER inhibits treatment if errors are detected, records actual treatment unit parameters, and allows this information to be stored and/or printed as part of the treatment record.
MOSAIQ includes the ViewStation, MLC Fit and SEQUENCER software applications as well as other applications that were not classified as medical devices when considered as individual products.
The provided document is a 510(k) Premarket Notification for the MOSAIQ Oncology Information System. It does not contain information about acceptance criteria or specific studies demonstrating the device's performance against such criteria.
The document explicitly states:
- "Clinical trials were not performed as part of the development of this product." (Page 3)
- "Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk." (Page 3)
- "Bench testing was performed... using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data. The product was deemed fit for clinical use." (Page 3)
Therefore, the specific information requested in the prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical studies is not available within this document.
The document asserts substantial equivalence to predicate devices based on intended use, safety, and effectiveness, citing its components (ViewStation, MLC Fit, SEQUENCER) that were previously cleared individually. The main claim for this 510(k) is the integration of these components and other non-medical device applications into a comprehensive oncology management system, with the highest concern being the "verify and record" functionality which interfaces with linear accelerators to detect mismatches between planned and actual machine settings.
§ 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.