Search Results
Found 1 results
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.
Ask a specific question about this device
Page 1 of 1