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510(k) Data Aggregation
(181 days)
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(168 days)
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(77 days)
The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.
The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection.
Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.
The TheraSphere 360 Y-90 Management Platform is an end-to-end, browser-based platform that will host a wide range of resources (e.g. radioembolization activity calculations, ordering, tracking, and education) that support Authorized Users of TheraSphere Microspheres.
The TheraSphere 360 Platform includes treatment planning functionality, activity calculation functionality, vial selection and ordering, and post-treatment analysis functionality. The treatment planning functionality and the activity calculation functionality include an interactive tool intended for calculating the activity of TheraSphere Microspheres required at the treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.
The Vial Selector function allows users to select and order TheraSphere Microspheres dose vials from inventory that match desired results.
The post-treatment analysis functionality is intended as an optional tool for post-treatment evaluation following TheraSphere Microspheres treatment.
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(202 days)
Sirona Advanced Imaging Suite is a Medical Image Management and Processing System and consists of four PET (Positron Emission Tomography) viewing features which is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: PET and CT.
These features are as follows:
- a. PET-CT overlay/fusion
- b. Measurement of Standardized Uptake Value on PET image series and generated PET-CT overlay/fusion
- c. Maximum Intensity Reconstruction of PET image series
- d. Multiplanar Reconstruction of PET image series and PET-CT overlay/fusion
Sirona Advanced Imaging Suite is intended to be used with the Sirona PACS (or MIMPS) Viewer.
The intended users of the PET Module are trained radiologists, medical professionals, or other healthcare providers within a healthcare organization.
Sirona Advanced Imaging Suite is a software-based imaging solution designed to facilitate the review, analysis, and interpretation of positron emission tomography (PET) and computed tomography (CT) imaging studies. Intended to be used with the Sirona PACS (or MIMPS) Viewer, this module enables healthcare professionals, including radiologists and nuclear medicine physicians, to visualize, manipulate, and analyze multi-modality medical images for diagnostic and clinical decision-making. Sirona Advanced Imaging Suite provides image fusion and co-registration capabilities, allowing users to overlay PET and CT images for combined anatomical and functional assessment. It supports multi-planar reconstructions (MPRs), maximum intensity projections (MIP), and standardized uptake value (SUV) calculations for metabolic activity assessment. The software is fully compatible with DICOM standards, ensuring seamless integration with imaging modalities and healthcare IT infrastructure.
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(70 days)
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning.
The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- Viewer 5.4.2 (General Viewing)
- Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
Universal Atlas Performer
Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer
Software that provides medical image data auto-segmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then "cloned" into the virtual image space of connected mixed reality glasses. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
The provided document describes the FDA 510(k) clearance for Brainlab AG's Viewer device. However, it explicitly states, "Viewer is not intended for diagnosis nor for treatment planning." This means the device primarily focuses on image display, manipulation, and basic measurements rather than making diagnostic or clinical decisions.
As such, the performance data presented is related to technical functionality and accuracy of measurements rather than diagnostic accuracy against a ground truth for a medical condition. Therefore, many of the requested sections regarding diagnostic performance, ground truth, experts, and comparative effectiveness studies are not applicable in the context of this specific regulatory submission.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
Given the nature of the device (medical image management and processing system, not for diagnosis), the acceptance criteria and performance reported are largely functional and technical.
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance/Outcome |
|---|---|---|
| Software Functionality | Successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing, cybersecurity tests. (General V&V) | Passed: Documentation indicating successful completion of these tests was provided, as recommended by FDA guidance. (Enhanced level) |
| Ambient Light Test | Determine Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions. | Passed: The display quality was determined to be sufficient. (Specific results not detailed beyond "sufficient visualization") |
| Hospital Environment Tests | Test compatibility of the Subject Device with various hardware platforms and compatible software. | Passed: Compatibility was confirmed. (Specific platforms/software not detailed) |
| Display Quality Tests | Measure and compare optical transmittance, luminance non-uniformity, and Michelson contrast of the head-mounted display (Magic Leap 2) to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. Tests were conducted with and without segmented dimming. | Passed: The tests ensured seamless integration, high visibility, and image quality. (Specific numerical results not detailed, but the outcome implies they met internal quality standards). |
| Measurement Accuracy Test | Inexperienced test persons (3) able to place distance measurements using a Mixed Reality user interface (Magic Leap controller) with a maximal deviation of less than one millimeter in each axis compared to mouse and touch on desktop as input methods. | Passed: The test concluded that the specified accuracy was achieved, meaning the maximal deviation was less than one millimeter. |
Study Details
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Sample size used for the test set and the data provenance:
- Measurement Accuracy Test: 3 inexperienced test persons. No information on the number of measurements or specific datasets used.
- Other Tests (Ambient Light, Hospital Environment, Display Quality): The sample sizes for these bench tests are not explicitly stated in terms of patient data or specific items tested, but represent functional validation of the system and its components.
- Data Provenance: Not applicable for the described functional and accuracy tests. The device deals with DICOM data, but the specific source of that data for these tests is not mentioned as the tests focus on the device's capabilities rather than clinical diagnostic performance on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Measurement Accuracy Test: No experts were explicitly mentioned for establishing "ground truth" for the measurement accuracy test. The comparison was between different input methods (Magic Leap controller vs. mouse/touch). The "ground truth" for these measurements would likely be the known distances within the virtual environment or the established accuracy of the mouse/touch methods themselves, assumed to be accurate. The "inexperienced test persons (3)" were the subjects performing the measurements, not experts establishing ground truth.
- Other Tests: Not applicable, as these were functional and technical performance tests not involving clinical ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests described are bench tests and functional validations, not clinical studies requiring adjudication of findings.
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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 MRMC comparative effectiveness study was done or is applicable. This device is cleared as a "Medical Image Management And Processing System" and explicitly states it is "not intended for diagnosis nor for treatment planning." Therefore, there is no AI assistance for human readers in a diagnostic context described, and no effect size would be reported.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the conventional sense of a diagnostic algorithm. The device's core function is to display and manipulate images with some basic automated measurements. The measurement accuracy test (3D measurement placement) involves human interaction with the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the Measurement Accuracy Test, the ground truth appears to be based on the established accuracy of desktop input methods (mouse and touch) for placing measurements, and the expectation of how accurately the mixed reality controller should perform relative to those. It is not an expert consensus on a clinical condition, pathology, or outcomes data.
- For other tests (Ambient Light, Hospital Environment, Display Quality), the "ground truth" refers to engineering specifications and visual quality standards.
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The sample size for the training set:
- Not applicable. This document describes a software update and clearance for an image viewing and manipulation device, not an AI/ML algorithm that requires a "training set" for diagnostic or predictive tasks.
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How the ground truth for the training set was established:
- Not applicable, as there was no training set mentioned.
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(93 days)
Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. Enterprise Imaging Desktops are intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.
MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling, image registration and segmentation can be used to enhance image viewing. Automatic spine labelling provides the capability to semi-automatically label vertebrae or disks.
As a comprehensive imaging suite, Enterprise Imaging Desktops integrates with servers, archives, Radiology Information Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records (EPR), reporting and 3rd party applications for customer specific workflows.
Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
When deployed as a hospital-wide Solution (Enterprise Imaging for Multispecialty Departments), Agfa HealthCare's Enterprise Imaging Desktops provides order generation, image acquisition, quality control, image reading, reporting, and review workflows for departments that have no such systems available including (but not limited to) dermatology, ophthalmology, gastroenterology, dental and general hospital use.
AGFA HealthCare's Enterprise Imaging XERO Viewer is a software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
This premarket notification is for AFGA HealthCare's Enterprise Imaging - Vessel Tracking functionality. The Vessel Tracking functionality is available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product.
Enterprise Imaging is a standalone software device (SaMD). AGFA HealthCare Enterprise Imaging Vessel Tracking functionality provides the capability to automatically create vessel centrelines, read the contour points and angles as well as provide minimum and maximum diameter of cross sections.
AGFA HealthCare's Enterprise Imaging Desktops is a medical image management and processing system (MIMPS), product code LLZ, which provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
AGFA HealthCare's XERO Viewer is a medical image management and processing system (MIMPS), product code LLZ, which is a web based software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data with associated reports and documents. XERO Viewer enables healthcare professionals to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer.
AGFA HealthCare's Enterprise Imaging Vessel Tracking adds the following new functionality available in both AGFA HealthCare's Enterprise Imaging Desktops product and Enterprise Imaging XERO Viewer product: a vessel analysis tool that provides the capability to automatically create vessel centrelines that can be used to monitor and analyze the progression of vascular diseases.
Vessel tracking is new functionality not included in the previous 510(k) clearances for Enterprise Imaging Desktops and Enterprise Imaging XERO Viewer. The vessel tracking algorithm however was previously included in AGFA HealthCare's IMPAX Volume Viewing 3.0 510(k) primary predicate K133135. The new device is substantially equivalent to the primary predicate device's (K133135) vessel analysis functionality.
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(160 days)
ProKnow DS is intended to be a data archive and processing software which supports review, analytics, and clinical decision-making with a focus on the data specific to radiation oncology patients.
ProKnow DS should be used in healthcare facilities by trained medical professionals including, but not limited to physicians, medical technologists, physicists and dosimetrists.
ProKnow DS provides a high-performance, scalable medical image management and processing system. It allows users to archive, inspect, analyze, and interact with radiation therapy patient data for both retrospective and prospective studies. Its features are centered on two primary areas of interaction: (1) single patient datasets and (2) collections of patient datasets, i.e., patient cohorts. Users are able to import patient data from existing imaging, contouring, and treatment planning systems (via DICOM formats). Once imported, patient data is archived for long-term storage and is also available for inspection and analysis (examples of supported inspection and analysis tasks include: visualizing images, structures, and dose distributions; inspecting plan information; inspecting dose volume histograms; and extracting metrics).
ProKnow DS also allows users to edit physical models associated with a patient for use in retrospective studies or to be exported to commercially available radiation treatment planning systems. Once a set of patients have been established in ProKnow DS, users may create collections of related patients allowing them to analyze and correlate dosimetric values of interest and clinical endpoints across large treatment populations.
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(268 days)
HPACS is a web-based software solution intended for storing, retrieving, transmitting, viewing, and processing medical images for non-diagnostic purposes. It operates in conjunction with a PACS server to enable access to imaging data.
HPACS supports the display and comparison of images from CR, CT, DX, MR, US, XA, and SC modalities that are compliant with the DICOM standard.
The system is designed for use by radiologists, technologists, and clinicians for reference and review purposes only. It is not intended for primary diagnostic interpretation.
HPACS supports operation on Windows 10 or higher and macOS 12 or higher platforms, exclusively via Google Chrome browser. Compatibility with other browsers or operating systems is not claimed.
HPACS is not intended for diagnostic image reading and should be used under standard indoor lighting conditions for optimal viewing; use in direct sunlight or high-glare environments is not recommended, and mobile or tablet devices are not supported. HPACS is not supported on any OS that is no longer officially supported by its manufacturer (e.g., Windows 7).
HPACS is a software system that allows healthcare professionals to access and manipulate medical images in real time using any web browser without device/location restrictions, without installing client software. The PACS application program runs on the AWS Cloud server. It stores, searches, and retrieves medical images and meta information using an initialization database based on secure communication, logging, DICOM tags stored in the DB, and file storage information stored in the AWS Cloud. AWS Cloud provides storage, query, and retrieval functions only to authorized users, and blocks unauthorized access. It also provides a web browser-based PACS/Web Viewer UI that can interact with the PACS application program to store and retrieve medical images and meta information.
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(167 days)
Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
Philips IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The solution also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow–up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.
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(257 days)
The uWS-Angio Pro is a post-processing software based on the uWS-Angio Basic for viewing, processing, evaluating and analyzing CT, MR, 3D XA images, and overlaying 2D medical images to support image guidance during interventional procedures. It has the following application:
The uWS-Angio Pro uTarget view application is intended to provide tools for adding the trajectory to the lesion. It also supports overlay of 3D datasets on 2D fluoroscopy images.
The uWS-Angio Pro uEmbo View application is intended to provide users with tools for planning and guiding interventional procedures. It offers a suite of features to mark targets, detect feeder vessels, and overlay the 3D image with the feeders and the corresponding anatomical X-ray image. When the overlay function is activated, it supports automatic 2D-3D image registration specifically for head neuroimaging, while the manual registration function is not restricted to any specific anatomical region.
The uWS-Angio Pro uCardiac View application is intended to provide users tools to plan and guide the interventional procedures. This application can use CT angiography images for vascular access analysis, aortic root analysis and angle management, and overlay registration display with 2D XA images.
uWS-Angio Pro is a software intended for viewing, processing, evaluating and analyzing medical images that comply with the DICOM 3.0 protocol. It supports interpretation and evaluation of examinations within healthcare institutions. It can be deployed on independent hardware such as a stand-alone diagnostic review and post-processing workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, it can be deployed on systems of the United Imaging Healthcare Angiography system family.
uWS-Angio Pro contains the following applications:
- uWS-Angio Pro uTarget View
- uWS-Angio Pro uEmbo View
- uWS-Angio Pro uCardiac View
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