Search Results

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."

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.

Ask a specific question about this device

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 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 multileaf collimators.
• · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment 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.
• · Observation of Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

The MOSAIQ Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilities efficient patient care. It can be configured for Medical 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 appointment views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and druglallergy interactions. MOSAIQ also performs standard calculations such as Body Sufface 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. MOSAQ's Medical Oncology functions are . 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 record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAQ's Radiation Can be used to support a wide variety of treatment modalities including INRT. IGRT, particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from TPS systems via DICOM import DICOM RT import.

The provided document, a 510(k) Premarket Notification for the Elekta MOSAIQ Oncology Information System, states that clinical trials were not performed as part of this product's submission. Instead, it indicates that "Validation testing involved simulated clinical workflows" and that "Non-clinical testing was written and executed to ensure that the system is working as designed."

Therefore, based on the provided text, the device did not undergo a study involving human subjects or a multi-reader multi-case (MRMC) comparative effectiveness study to prove it meets specific acceptance criteria related to its performance in a clinical setting with human readers. The document explicitly states:

• No clinical trials: "Clinical trials were not performed as part of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effective can be performed such that no human subjects are exposed to risk." (Page 6)
• Validation through simulated workflows and non-clinical testing: "Validation testing involved simulated clinical workflows, described in section 16.8. The product was deemed fit for clinical use. Non-clinical testing was written and executed to ensure that the system is working as designed use executed, including tests to verify requirements for new product functionality, tests to ensure that instion as intended, and regression tests to ensure continued safety and existing functionality. MOSAIQ passed testing and was deemed safe and effective for its intended use." (Page 6)

Given this, it's not possible to provide the requested information regarding:

• Acceptance Criteria Table and Reported Device Performance (Table 1): The document does not describe specific quantitative acceptance criteria or clinical performance metrics for the device that would be typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Its validation focused on functional correctness against design specifications.
• Sample size and data provenance for test set: No test set of clinical cases is described.
• Number of experts and qualifications for ground truth: No experts were used for establishing clinical ground truth for a test set.
• Adjudication method for test set: Not applicable as there was no clinical test set.
• MRMC comparative effectiveness study: Explicitly stated as not performed.
• Standalone performance: While internal non-clinical testing was done, the document doesn't provide performance metrics in the way an AI algorithm's standalone performance might be reported (e.g., AUC, F1 score).
• Type of ground truth: The "ground truth" for the non-clinical and simulated workflow testing would be the predefined system requirements and expected outputs, rather than expert consensus, pathology, or outcomes data from real patients.
• Sample size for training set: No training set for an AI/ML model is mentioned, as the device is described as an "Oncology Information System" and not an AI-driven diagnostic or assistive tool in the context of this submission.
• How ground truth for training set was established: Not applicable.

Summary of Device Validation as per the Document:

The provided document indicates that the device's safety and effectiveness were demonstrated through:

• Substantial Equivalence: Comparison to legally marketed predicate devices (MOSAIQ K141572) and a reference device (The ViewRay (MRIdian) Linac System K162393) based on intended use and technological characteristics (detailed in tables on Pages 8-9).
• Non-Clinical Testing: Verification tests to ensure the system works as designed, including:
  • Verification of new product functionality requirements.
  • Ensuring installation as intended.
  • Regression tests for continued safety and existing functionality.
• Simulated Clinical Workflows: Validation testing performed using simulated clinical scenarios, without human subjects.

This approach is common for information systems and record-keeping devices where the primary function is workflow management, data integration, and safety checks, rather than direct diagnostic interpretation or image analysis using AI. The "level of concern" for the software was identified as "major" due to its interface with linear accelerators and responsibility for detecting mismatches, which could lead to serious injury if it failed. Therefore, the non-clinical and simulated testing would have rigorously focused on these critical safety functions.

Ask a specific question about this device

MOSAIO® 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 multileaf ● collimators.
• Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIO® 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. .

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, stereotactic localization, treatment plan review, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery.

This Premarket Notification addresses the addition of the Locate module for Radiation Oncology, which adds stereotactic localization capability to MOSAIQ.

The provided document is a 510(k) premarket notification for the MOSAIQ Oncology Information System. It describes the device's intended use, functionalities, and a comparison with predicate devices to establish substantial equivalence. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria.

Here's a breakdown of what can and cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding quantitative performance metrics for the MOSAIQ Oncology Information System. Instead, it describes a summary of non-clinical testing where "Verification tests were written and executed to ensure that the system is working as designed. Over 100 test procedures were executed, including tests to verify requirements for new product functionality were met, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Pass/fail criteria for this testing effort was similar to past testing efforts for the previous versions of MOSAIQ. MOSAIQ passed testing and was deemed safe and effective for its intended use."

While it confirms tests were performed and passed, specific numerical acceptance criteria (e.g., accuracy percentages, error rates, time limits) and the detailed study results meeting those criteria are not provided. The "reported device performance" is a qualitative statement of "passed testing and was deemed safe and effective."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Bench testing was performed...using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data."

• Sample Size for Test Set: The exact number of patient data samples used for testing is not specified. It mentions "actual patient data," but not how many cases or the size of this dataset.
• Data Provenance: The country of origin for the "actual patient data" is not specified. It does not indicate whether the data was retrospective or prospective, though the term "simulated clinical workflows" often implies a retrospective or synthetic approach.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The document refers to "actual patient data" and "simulated clinical workflows," but it does not describe the process of establishing ground truth for this data, nor does it mention the involvement or qualifications of experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. There is no mention of any adjudication process for the test results or the ground truth.

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

The document states, "Clinical trials were not performed as part of the development of this product. 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."
Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance was not performed. The device, an Oncology Information System, is not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are typically applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "Verification tests were written and executed to ensure that the system is working as designed." These tests would inherently represent a form of standalone testing of the software's functionality against its requirements.
However, the device is designed to interface with human users ("alerting the user," "warns the user") and is an "Oncology Information System" that "supports information flow among healthcare facility personnel." This implies a human-in-the-loop system where the software provides information and alerts, but human clinicians make final decisions. While individual sub-functions of the software (e.g., dose calculation, mismatch detection) would have been tested in a standalone manner, the overall system is not purely "algorithm only" without human interaction in its intended use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document uses "actual patient data" in its bench testing but does not specify the type of ground truth established for this data (e.g., whether it was based on pathology, expert consensus, or clinical outcomes). The testing focused on verifying the system's design and functionality rather than diagnostic accuracy against a specific ground truth. For instance, for the "mismatch" warning function, the ground truth would be whether a mismatch truly existed between planned and actual settings, rather than a clinical outcome.

8. The sample size for the training set

This information is not applicable or not provided. The MOSAIQ Oncology Information System, as described, appears to be a rule-based software system for managing workflows and information in oncology, rather than a machine learning or AI system that requires a "training set" in the conventional sense. The document does not mention any machine learning components that would necessitate training data.

9. How the ground truth for the training set was established

This information is not applicable or not provided as there is no mention of a "training set" or machine learning models.

In summary, the provided document focuses on establishing substantial equivalence for an Oncology Information System based on its functionalities and comparison with predicate devices, rather than detailed performance metrics against specific acceptance criteria relevant to diagnostic or AI algorithms. The "study" referenced is a series of "verification tests" performed internally, without the rigorous quantifiable metrics often associated with AI/ML device evaluations.

Ask a specific question about this device

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 multileaf . 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. .

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.

This Premarket Notification addresses the addition of the "Evaluate" module, which calculates and displays dose volume histograms (DVHs) for the purpose of review and evaluation of radiation treatment plans.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MOSAIQ Oncology Information System:

It's important to note that this document is a 510(k) Premarket Notification summary for software, specifically an Oncology Information System (MOSAIQ). Such notifications primarily focus on demonstrating substantial equivalence to a predicate device and usually involve software verification and validation, not clinical trials in the sense of demonstrating diagnostic accuracy or efficacy in a patient population. Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/algorithm-based diagnostic device will not be present.

Based solely on the provided text, many of the requested categories (especially those related to clinical performance, ground truth, and expert evaluation) are not applicable or not reported as they would be for a typical AI diagnostic device.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative performance-based acceptance criteria for a "device" in the sense of an AI algorithm producing a measurement or diagnosis. Instead, the "device" is an information system, and its acceptance criteria are implicitly tied to the successful completion of non-clinical verification and validation testing, ensuring it functions as designed and meets safety requirements.

Study Details: MOSAIQ Oncology Information System

This submission focuses on software validation rather than a clinical study evaluating diagnostic performance.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Test Set Description: "Bench testing was performed... using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data."
   • Sample Size: Not specified for the "actual patient data" used within the bench testing. The total number of test procedures was "Over 100."
   • Data Provenance: "actual patient data" implies retrospective, but no country of origin is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications: Not specified. For software verification and validation, "ground truth" would typically be defined by engineering specifications, expected outputs, and clinical input from subject matter experts (e.g., oncologists, physicists, dosimetrists) who validate the functional correctness of the system rather than establishing a diagnostic truth for patient cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable as this was not a human reader study requiring adjudication of interpretations. The "adjudication" would be through verifying test procedure results against expected outcomes defined during the software development lifecycle.

4. 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 MRMC comparative effectiveness study was done. The document explicitly states: "Clinical trials were not performed as part of the development of this product." and "Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device."

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense. The non-clinical testing was focused on the software's ability to perform its functions independently ("algorithm only") under simulated conditions, but the device's intended use is with a human in the loop, as an information system for workflow management and to warn users. The testing verified the software's functional correctness.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of software would be based on:
     • Functional Specifications/Requirements: The software must perform according to its design documents.
     • Clinical Domain Knowledge: Accuracy of calculations (e.g., dosage, DVHs) and correctness of comparisons (e.g., planned vs. actual machine settings) would be validated against established medical/physics principles and expected clinical outcomes.
     • Expected Outputs: For test cases, the correct output (e.g., a specific DVH curve, a warning message for a mismatch) would be predefined and compared to the software's actual output.

7. The sample size for the training set:

   • No "training set" in the context of machine learning was mentioned or indicated. This is a rule-based/deterministic software system, not an AI/ML-based system that requires training data.

8. How the ground truth for the training set was established:

   • Not applicable, as there was no machine learning training set mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device