(14 days)
The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e.
- Displaying
- Processing
- Reading
- Reporting
- Communicating / distributing
- Storing / archiving of radiological softcopy images and
- Storing / archiving of structured (DICOM) reports.
The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and primary diagnosis of mammography images).
Therefore CHILI PACS supports the following generic imaging workflow:
- Receive scheduled exams from IS at the CHILI PACS archiving component CHILI . Server
- Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces
- Receive and store new exams from the Modalities at the CHILI Server
- · Prepare images for reading
- Report new images, if required by comparing them with prior exams and reports
- · Demonstrate exams at Radiological Demos
- View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).
Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.
CHILI PACS is a "software only" - solution. It is a modular system, consisting of modules which can be combined for the specific needs of a customer, including a backend communication and storage component and different workplace deployments for medical imaging tasks and applications.
CHILI PACS is the integrated radiology suite for radiological practices and community hospitals. Important factors are the centralized server structure, the wide-ranging data distribution and the overall integrated concept, ranging from reporting and archiving as well as image and report distribution.
The three CHILI PACS workplace deployments
- a) CHILI Web for image distribution (web-based viewing application suited for primary diagnosis)
- b) CHILI Workstation for reporting, inside as well as outside of the radiology (standalone workstation or client workstation connected to server)
- c) CHILI 3D-Plugln (optional) for 3D- and 4D reconstructions of image slices generated by digital modalities and stored in the DICOM format (not intended for primary diagnosis)
are medical diagnostic and viewing workstations intended for manipulating, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allows radiologists, radiological technicians and health care professionals to receive and process all data needed.
Data Management: CHILI Server.
Ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.
The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.
Integration: CHILI Workflow Integration.
The Workflow Management enables by integration of any HL7- / DICOM-compatible HIS, RIS (IHE Year 5) and other information systems to the CHILI PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.
The medical device being described is "CHILI PACS," a Picture Archiving and Communication System (PACS). This submission does not include a study or acceptance criteria related to device performance in diagnosing or treating conditions, as it is a PACS system primarily focused on image management, display, and distribution, rather than diagnostic AI capabilities.
The primary objective of this 510(k) submission (K070796) is to establish substantial equivalence to an existing legally marketed device (syngo Imaging Version V20A K052461), implying that the new device meets the same safety and effectiveness standards without introducing new risks. Therefore, the "acceptance criteria" here relate more to regulatory compliance and equivalence to the predicate device, rather than specific performance metrics for a diagnostic algorithm.
Here's the breakdown based on the provided text, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a PACS system designed for image management and viewing, rather than a diagnostic AI, there are no specific performance metrics like sensitivity, specificity, or AUC provided in the submission for a diagnostic task. The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and adhering to general safety and effectiveness standards.
| Acceptance Criterion (Implicit for PACS) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Functional Equivalence | CHILI PACS performs functions similar to predicate device (image display, processing, reading, reporting, communication, distribution, storage, archiving). |
| Technical Characteristics Equivalence | CHILI PACS has similar technical characteristics to predicate device (software-only, supports DICOM, client/server architecture). |
| Safety - No new potential safety risks introduced | Risk analysis conducted, hazards controlled via software development, verification, and validation testing. Adherence to recognized industry practices and standards. |
| Effectiveness - Safe and effective use provided by labeling | Device labeling contains instructions for use, cautions, and warnings. |
| Compliance with Regulatory Standards | Adheres to guidance documents for medical image management devices and software, and off-the-shelf software use. |
| Intended Use Equivalence | Intended use is consistent with the predicate device for enhancing imaging workflow and assisting physicians in diagnosis/treatment planning (excluding mammography primary diagnosis/screening). |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical performance study using a "test set" in the context of diagnostic accuracy. The testing mentioned refers to "verification and validation testing" which is standard software quality assurance, not device performance testing on patient data for diagnostic accuracy.
- Sample Size for Test Set: Not applicable in the context of a diagnostic performance study.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no diagnostic performance study on a test set with expert-established ground truth is described.
4. Adjudication Method for the Test Set
Not applicable, as no diagnostic performance study on a test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate PACS system for image management and viewing, not on the comparative diagnostic performance of human readers with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of a diagnostic algorithm was not done. CHILI PACS is a "software only" solution for image management and viewing, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
Not applicable, as no diagnostic performance study requiring clinical ground truth (like pathology, expert consensus, or outcomes data) is described. The device is a PACS system for managing medical images.
8. The Sample Size for the Training Set
Not applicable. CHILI PACS is an image viewing and management system and does not mention any machine learning or AI components that would require a "training set" for diagnostic algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a diagnostic algorithm is described.
§ 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).