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510(k) Data Aggregation
(71 days)
Medsynapse RIS PACS Software is intended for use as a fully web based application on an off-the shelf PC which is networked with a Medsynapse RIS PACS server. The Medsynapse RIS PACS software can process medical images from DICOM compliant modalities and non DICOM sources. The Medsynapse RIS PACS software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports.
It enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, cardiologists, technologists, sonographers, technicians, nurses and clinicians. MIP, MPR, and Fusion are not intended for Mammography use.
Medsynapse VNA is an open standards based archiving methodology used for storing images in non-proprietary format.
The Medsynapse RIS PACS Software may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.
Medsynapse RIS (Radiology Information System) PACS is a fully web based, enterprise-wide application intended for communication, storage, display, printing, and processing of medical images. Its software components perform operations related to image manipulation and measurements relevant to radiology and cardiology. As a software-only device, it does not control image acquisition. Typical users of Medsynapse RIS PACS are radiologists, technologists, sonographers, technicians, nurses, and clinicians. The software runs on standard PC equipment using MS Windows operating systems meeting minimum system requirements. Medsynapse VNA (Vendor Neutral Archive) is an open standards-based archiving methodology used for storing images in non-proprietary format.
The provided document describes a 510(k) premarket notification for Medsynapse RIS PACS & Medsynapse VNA, claiming substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, often through a comparison of technological characteristics and performance testing.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for the Medsynapse RIS PACS & Medsynapse VNA itself. Instead, the submission for this PACS system focuses on demonstrating substantial equivalence to a predicate device (K190232, Fujifilm Synapse PACS) by comparing their characteristics.
The "acceptance criteria" in this context are implicitly that the new device performs equivalently to the predicate device and meets relevant regulatory and safety standards. The reported device performance is largely a qualitative comparison against the predicate.
| Feature/Characteristic | Acceptance Criteria (Implicit - Equivalent to Predicate) | Reported Device Performance (Medsynapse RIS PACS & VNA) |
|---|---|---|
| Indications for Use | Functionally identical to predicate for processing, display, measurement, calculations, reporting, 3D display (MIP/MPR) for CT, MR, PET, SPECT, and lossless/non-compressed mammography. | "The indications mean the same thing with slightly different wording." (Directly stated in comparison table). |
| DICOM Compatibility | DICOM compatible. | DICOM compatible (SAME as predicate). |
| Application Type | Multipurpose, enterprise-wide application for communication, storage, display, printing, and medical image processing. | SAME (as predicate). |
| Typical Users | Radiologists, cardiologists, technologists, sonographers, technicians, nurses, clinicians. | SAME (as predicate). |
| Supported Modalities | Plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, DICOM compliant modalities, mammography with appropriate display resolution. | SAME (as predicate). |
| HIPAA Compliance | YES (HIPAA compliant). | SAME (as predicate). |
| Computer/Operating System | Windows PC. | SAME (as predicate). |
| Software Validation & Risk Analysis | No new issues of safety or effectiveness; meets guidance documents: Content of Premarket Submissions for Software, Off-The-Shelf Software Use, Cybersecurity, Content of Premarket Submissions for Management of Cybersecurity; Risk management in accordance with IEC 14971. | "The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific test set or clinical data for assessing the performance of Medsynapse RIS PACS & Medsynapse VNA against a ground truth in a clinical setting. The evaluation is based on "Bench/Performance Testing" which refers to software validation and risk analysis, not a clinical study involving a test set of patient data.
3. Number of Experts and Qualifications for Ground Truth Establishment
Since no clinical test set or ground truth establishment is described, there is no information provided regarding the number or qualifications of experts used for establishing ground truth.
4. Adjudication Method for the Test Set
As no clinical test set is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was conducted. The submission focuses on demonstrating substantial equivalence by comparing technological characteristics and software validation, not by measuring improvement in human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The device itself is a PACS (Picture Archiving and Communications System) and VNA (Vendor Neutral Archive) software, which are tools for managing, displaying, and processing medical images. It does not appear to be an AI algorithm designed for automated interpretation or diagnosis. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study in the context of diagnostic AI is not applicable to this device as described. The software provides "toolsets for performing measurements," "solving clinical calculations," and "creating and distributing structured reports," implying it assists human users rather than performing standalone diagnostic tasks.
7. Type of Ground Truth Used
Given that no clinical performance study involving a test set is described, no specific type of ground truth (expert consensus, pathology, outcomes data, etc.) was used for this submission. The validation relies on software engineering principles and comparison to the predicate.
8. Sample Size for the Training Set
Similar to the test set, the document does not mention a training set sample size. This device is a PACS/VNA system, not a machine learning model that would typically require a training set for its development.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set, the question of how its ground truth was established is not applicable.
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(22 days)
With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms.
MEDSYNAPSE ZERO FOOTPRINT VIEWER allows distribution of images within and outside the Hospital. It acquires, transmits, stores, retrieves, and displays digital images and related patient information from a variety of imaging sources and communicates the information over a network. It facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short- or long-term storage devices. MEDSYNAPSE ZERO FOOTPRINT VIEWER allows communication using local or wide-area networks, public communications services, systems that include modality interfaces, and gateways to healthcare facility and departmental information systems.
The Medsynapse Zero Footprint Viewer is a Picture Archiving and Communications System (PACS) software. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed acceptance criteria and a comprehensive study report for the device's performance.
Based on the information provided, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative or pass/fail format typical for device performance metrics. Instead, it relies on demonstrating technological similarities and equivalence to a predicate device.
The "Technological Comparison" table (pages 4-5) serves as the primary "performance" demonstration in this context, showing that the Medsynapse Zero Footprint Viewer shares identical characteristics and functionality with the predicate device, RapidResults (K141881, RamSoft, Inc.).
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Medsynapse Zero Footprint Viewer) |
|---|---|---|
| Indications for Use | "This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms." | "With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms." |
| Features | Zero-download Image Viewer, Devices: Windows, Android, MAC, iPhone, iPad, Touch or Keyboard and Mouse, Multiple browser support, Diagnostic use on desktops but not mobile devices, Window/Level, Zoom, Rotation, Flip, Pan, Measure, and Annotation. Does not produce or alter any images and medical data. | Identical features as the predicate device. |
| Modalities Supported | View all image modalities, including Xray, CT, MRI, color ultrasound and XRay angiography. | Identical modalities supported as the predicate device. |
| HIPAA Compliance | Secured connection to PACS using HTTPS. Images stay in PACS, not on the device. Images and information are gone from the device when the browser/app is closed, no storage on user's device. | Identical HIPAA compliance characteristics as the predicate device. |
| Architecture | Server-based software solution that displays images and reports from a PACS using a zero-footprint application (HTML5), no installation needed. | Identical architecture as the predicate device. |
| Technology Standards | Use of various technology standards (LDAP, SSO, HTTPS, HTML, HTML5, CSS, XML, web services, etc.) | Identical technology standards use as the predicate device. |
The study proving these "acceptance criteria" (i.e., equivalence to the predicate) is the Bench/Performance Testing described in Section 6 of the 510(k) Summary. It states: "The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device."
2. Sample sized 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. The document refers to "bench testing" and "software validation" but does not detail the specific test cases, datasets, or their provenance.
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 applicable/not provided. For a PACS viewer claiming substantial equivalence based on technological characteristics and software validation, detailed expert-established ground truth for a test set (like in an AI algorithm validation) is typically not required or reported in this format. The validation would focus on software functionality and image display accuracy against established standards, not diagnostic accuracy against expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. See point 3.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. This type of study is relevant for AI-powered diagnostic aids, not for a PACS viewer which is a tool for displaying images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study is not applicable/not done in the context of this device. A PACS viewer does not operate as a standalone algorithm in the way an AI diagnostic tool would. Its function is to display images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of a PACS viewer's validation for 510(k) clearance. The ground truth for such a device would relate to the accurate display of medical images according to DICOM standards and its own specifications, rather than diagnostic outcomes.
8. The sample size for the training set
This information is not applicable/not provided. The Medsynapse Zero Footprint Viewer is a PACS software, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. See point 8.
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