(119 days)
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting. syngo.plaza is a "software only"-system. which will be delivered on DVD to be installed on common IT hardware, matching the syngo.plaza hardware requirements. syngo.plaza will be installed by Siemens implementation engineers. The integration into customer specific 17 environments is offered based on professional services. Updates / upgrades are offered based on service contracts and fulfilled by trained service technicians.
The provided text describes the Siemens syngo.plaza VB10A, a Picture Archiving and Communication System (PACS), and its substantial equivalence to a predicate device (syngo.plaza VA20A). It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of submission generally does not include extensive clinical studies or detailed performance metrics against specific acceptance criteria. Instead, it relies on demonstrating similar technical and functional characteristics to a previously cleared device.
Therefore, many of the requested details regarding acceptance criteria, specific performance metrics, and detailed study information are not present in the provided document, as they are not typically required for a 510(k) submission for a PACS device of this nature. The information below is extracted or inferred from the provided text where possible, and explicitly states where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission for aPACS device, "acceptance criteria" are primarily related to functional equivalence, adherence to standards, and safety. There are no quantitative diagnostic performance metrics presented for the device itself in this document. The "performance" is largely described in terms of functional parity with the predicate device and adherence to listed standards.
| Acceptance Criteria Category | Description of "Acceptance" (as inferred from document) | Reported Device Performance (as described in the document) |
|---|---|---|
| Functional Equivalence | The device must have substantially equivalent intended use and similar technical characteristics as the predicate device (syngo.plaza VA20A) for specific functionalities. This is the primary "acceptance criterion" for a 510(k) submission of this type. | The document provides extensive tables comparing the functionalities of syngo.plaza VB10A with syngo.plaza VA20A, detailing features such as image communication, data compression, storage, user administration, OEM interfaces, user interface, RIS communication, hardware, client installation, application packages, image processing features, and image processing algorithms. The conclusion states that "syngo.plaza VB10A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device." New features like "Token view," "Smart Read feature," "Angle on Stack" functionality, and "Patient ID" are introduced, but the overall functionality is deemed equivalent. |
| Safety and Effectiveness (General) | The device labeling must contain instructions for use, cautions, and warnings to ensure safe and effective use. Risk management processes must identify potential hazards and control them through software development, verification, and validation testing, adhering to recognized industry practices and standards. | The device labeling includes instructions, cautions, and warnings (updated for clarity and scope compared to predicate). Risk management was performed via a risk analysis (RIM115291/mv300_risk_1-11.1 and RIM115372/plaza_risk_PatientIdentification-Truncation_CDR) during software development, verification, and validation to minimize identified hazards. The device is classified as Safety Class B according to IEC 62304. |
| Adherence to Standards | The software verification and validation (Unit Test, Integration Test, System Test) for all newly developed components and the complete system must be performed according to specified international and FDA-recognized standards. | Verification and validation were performed according to: ISO 14971:2007 (DIN EN ISO 14971:2012 used in Germany), AIMI/ANSI ES 60601-1:2005/(R) 2012 + C1:2009/(R) 2012 (clause 14), IEC 62304:2006, IEC 62366:2007, DICOM Standard [2011], HL7 [2006], ISO / IEC 10918-1:1994 + TC 1:2005, ISO / IEC 15444-1:2005+TC 1:2007, ISO / IEC 13818:2009. The device conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards. |
| Mammography Imaging | For primary image diagnosis in Mammography, only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Additionally, monitors (displays) and printers which have received FDA clearance for Mammography must be used. | The device's intended use explicitly states these requirements for mammography images. This is a user requirement, not a direct performance metric of the software itself, but rather a proper use condition it is designed to support. |
Note: This document does not contain quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image interpretation, as the device is a PACS for display and management, not a diagnostic algorithm that provides an output needing validation against clinical outcomes. The "study" here is primarily a series of verification and validation activities against engineering and regulatory standards, and a comparison against a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing including Unit Test Level, Integration Test Level, and System Test Level performed for newly developed components and the complete system. This implies testing against technical specifications and requirements, rather than a "test set" of patient data in the clinical sense for performance evaluation.
- Sample Size for Test Set: Not specified. The document does not refer to a "test set" in terms of patient cases or images for evaluating diagnostic performance. Testing was for software functionality, safety, and adherence to standards.
- Data Provenance: Not applicable/Not specified. As this is primarily software verification and validation, there is no mention of country of origin for clinical data or whether it was retrospective or prospective. The testing would have involved simulated data, test cases designed to check functionalities, and potentially a range of DICOM images to ensure compatibility and correct display/processing.
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)
- Number of Experts: Not applicable/Not specified. Since this is a PACS system and the application is for functional equivalence, there is no mention of expert radiologists establishing ground truth for diagnostic purposes within this 510(k) summary. The "ground truth" for software functionality would be the defined specifications and expected behavior, tested by software engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Given that the testing is focused on software functionality, safety, and adherence to standards, the concept of "adjudication" for a clinical test set is not present in this document.
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
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers utilized AI. The device is a PACS system, not an AI-powered diagnostic aide.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This device is a PACS and its function is to display, process, and manage medical images for human interpretation, not to provide standalone diagnostic outputs. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/Not specified for clinical outcomes. For the software verification and validation, the "ground truth" would be the documented functional requirements, design specifications, and expected outputs of the software features (e.g., correct image display, accurate measurements, proper storage, and retrieval). There is no mention of clinical ground truth (like pathology or outcomes data) being used to evaluate the device's performance in a diagnostic capacity.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As the device is a PACS system and not an AI/ML algorithm that requires training data in the diagnostic sense, there is no mention of a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. See point 8.
§ 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).