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510(k) Data Aggregation
(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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