(218 days)
VM PACS with VM Medical Workstation is a software designed to receive, store, distribute, process and display Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data throughout a clinical environment. The software performs digital communication and storage of the images and is meant to be administrated by a trained user.
VM Medical Workstation and VM Clinical Viewer are both softwares capable to perform image processing, measurement and other diagnostics tools, it is designed to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
VM PACS is designed to Store Medical Dicom Images and leave them available to be used for diagnostics or transferred to other Dicom devices.
VM PACS is not meant to create or modify DICOM images. VM PACS store the images and the Data Set send by an DICOM compatible image diagnostic equipment and store them making them available to be access by a workstation or viewer, or been transfer to another Dicom Compatible device.
VM PACS does not modify the images store in it.
User Graphic interface VM Medical Workstation is a complete Workstation which provides diagnostic tools for image diagnose, for CT, MR, PT, CR, DX, NM, MG, XA, RF, SC, US and ES, as zoom, Window & Level variation and presets, measurements and a complete set of diagnostics tools and includes a report tool for the studies.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
VM Clinical Viewer is the web access interface of VM PACS, which allows integration with any Operating System, brings to the institution the capacity to access the images remotely.
VM Clinical Viewer allows the specialist consultation and the communication between radiologists and referring physicians. The system enables authorized external users to have access to specific patient studies, is not intended for diagnostic purposes when used on mobile devices.
VM PACS with VM Medical Workstation is a software composed by a Picture Archiving and Communication System able to receive, transfer and display Dicom Images acquired and send by imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices, along with a Graphic interface used to configure the PACS and diagnose Medical Images Stored in it.
VM PACS is an affordable and scalable Picture Archiving and Communication System designed to optimize imaging workflow and simplify image management. Use a powerful database engine as client server data. The system architecture scalable, allowing to add storage media according to the volume of studies intended to store and be access online. This gives the possibility to increase gradually the investment in hardware storage as needed. All Image Storage and communications are according to the Dicom Standard. A configuration interface allows the system administrator to set the Application Entity Title (AE-TITLE) and listening port for the Dicom Communications with other devices. To protect the studies PACS has a full-featured fully automatic and programmable backup instance. VM PACS is capable to send query and retrieve studies from other Dicom Applications using the DICOM standard. For Monitoring the Dicom traffic, incorporating a tool which shows all the DICOM transfers in a lapse of time, also VM PACS can be set to auto send studies to other Dicom Application Entities (AEs), depending on the modality, the description, the patient, or any other Dicom Tag selected and also can send all the previous studies from the same patient to a tarqet Dicom AE.
VM Medical Workstation provides all the necessary tools needed for image diagnosis. VM Medical WS allows the user to visualize; report and print images and studies, whit a complete set of tools designed for diagnose medical images. VM Medical Workstation includes a report module to archive the diagnostic results, linked to the informed study. VM Medical WS allows the authorized user to burn studies in a CD/DVD along with the study have an autorun software with diagnostic Dicom tools. If the study has a report, this report is attached to the CD/DVD in a PDF format. The software also include an Advance Printing tool which allows the user to perform a personalized layout, changing window & Level, zoom, and pan to one or all images in the layout.
VM Clinical Viewer is the diagnostic web access interface of VM PACS, which allows integration with any Operating System, and allows the institution to access the images remotely. VM Clinical Viewer improves the specialist consultation and the communication between radiologists and referring physicians from any location in the world. The system enables authorized external users to have access to specific patient studies. VM Clinical Viewer is not intended to be use with diagnostics proposes in mobile devices.
The provided document is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS) with a medical workstation (VM PACS with VM Medical Workstation). This type of device is classified as a Class II medical device (21 CFR 892.2050) and is subject to general controls. The document aims to demonstrate substantial equivalence to a legally marketed predicate device (K123174 CENTRICITY PACS-IW WITH UNIVERSAL VIEWER by GE HEALTHCARE).
Crucially, this document is a regulatory submission for a PACS system, which is a software for storing, displaying, and managing medical images. It is not an AI/ML-driven diagnostic device that would typically have acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC, nor does it involve a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial demonstrating AI performance.
Instead, the "acceptance criteria" for a PACS system in a 510(k) submission generally revolve around demonstrating compliance with DICOM standards, functional equivalence to a predicate device, and verification of software functionality and safety. The "study" mentioned is not a clinical performance study but rather a demonstration of technical characteristics and functional equivalence.
Therefore, many of the requested points regarding AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this specific type of device and submission.
Here's how I can address the prompts based on the provided document:
Acceptance Criteria and Device Performance for VM PACS with VM Medical Workstation
Since this is a PACS system and not an AI/ML diagnostic tool, the "acceptance criteria" are derived from demonstrating substantial equivalence to a predicate device and adherence to relevant standards (primarily DICOM). The "reported device performance" refers to the system's demonstrated functionality as described in the submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence and DICOM Compliance) | Reported Device Performance (Summary) |
|---|---|
| DICOM Standard Compliance | VM PACS and VM Medical Workstation are designed by DICOM Standards (e.g., DICOM 3 compliance explicitly mentioned). |
| Image Storage and Retrieval | VM PACS is designed to store Medical DICOM Images and make them available for diagnostics or transfer to other DICOM devices. It can receive, send, query, and retrieve studies from other DICOM Applications. |
| Image Display and Manipulation | VM Medical Workstation provides diagnostic tools for image diagnosis (CT, MR, PT, CR, DX, NM, MG, XA, RF, SC, US, ES) including zoom, Window & Level variation and presets, measurements, and a reporting tool. VM Clinical Viewer provides web access for remote viewing. |
| Data Integrity (No Modification of Images) | VM PACS is explicitly stated not to create or modify DICOM images stored in it. |
| Compatibility with Modalities and Operating Systems | Supports all DICOM modalities, Dicom, JPEG, and JPEG 2000 compliant image sources, TCP/IP connectivity. Compatible with Microsoft Windows /XP Professional/7/8 and Windows Server 2003/2008/2012 (32/64 bits) for server and workstation. Web interface has Linux and iOS compatibility. |
| Equivalence in Intended Use and Indications | Intended use and indications for use are presented as substantially equivalent to the predicate device, focusing on receiving, storing, distributing, processing, and displaying DICOM and non-DICOM information throughout a clinical environment, and providing diagnostic tools for trained professionals. |
| Safety and Effectiveness (No New Issues) | "This device poses no new issues of safety or effectiveness, and is substantially equivalent to the predicate device." (This is a conclusion made by the applicant based on their comparison and nonclinical testing, not a specific performance metric.) "The device does not contact the patient, nor does it control any life sustaining devices." "A trained physician... interprets images and information displayed and printed by this software." |
| Software Development & Validation | Designed, developed, tested, and validated according to written procedures (though details not provided for specific "acceptance criteria" here, it's a general claim for regulatory compliance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it's not a clinical performance study involving a test set of patient data to measure diagnostic accuracy. The "testing" mentioned refers to nonclinical testing of technical characteristics, general function, and application (para 7.3.3).
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 and is not applicable to this type of device submission. There is no "ground truth" establishment in the context of image interpretation performance for a PACS system; its primary function is image management and display.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable. Since there is no clinical test set for diagnostic performance, there's no adjudication method.
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
There was no MRMC comparative effectiveness study and this is not applicable as the device is a PACS system, not an AI-driven diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a Picture Archiving and Communication System, which is a foundational system for medical imaging workflow, not a standalone diagnostic algorithm. Human users (physicians, radiologists) interact directly with the software for viewing and interpreting images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The device's function does not involve making diagnostic claims that would require a "ground truth" for diagnostic performance evaluation.
8. The sample size for the training set
This information is not provided and is not applicable. The device is not an AI/ML model trained on a dataset for diagnostic purposes.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).