(105 days)
SntryPACS is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.), Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. SntryPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records. Typical users of the system are trained medical .professionals (e.g. physicians, radiologists)
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
SntryPACS Server is a fully integrated DICOM Storage and DICOM Application Server, compatible with any DICOM modality and most DICOM viewing workstations.
SntryPACS server runs under the QStar storage server environment and provides PACS services such as storage provider and query retrieve provider. Both of these services runs as Linux daemons and utilizes DBMS system and file indexers for managing the medical images and reports. A typical SntryPACS network consists of a central SntryPACS server which stores a database containing the images, and of multiple clients that can retrieve and display these images on medical imaging software. The images are stored in DICOM format. The modalities (MRI, CT, PET, Ultrasounds, etc.) send the images to the PACS Server by using a DICOM "push" (DICOM C-Store). The server and the client workstations communicate by using the DICOM protocol (DICOM C-Store or Query & Retrieve). The clients display the images by using medical imaging software such as a DICOM viewer or a radiology review workstation client software system.
This appears to be a 510(k) summary for the SntryPACS™ device, which is a Picture Archiving Communications System (PACS). For such a device, the acceptance criteria and study information related to device performance in a clinical context (e.g., diagnostic accuracy) are typically not included as they are for AI/CADe systems.
A PACS system like SntryPACS™ primarily focuses on the technical performance of archiving, communicating, processing, and displaying medical images reliably and efficiently, rather than performing diagnostic interpretations itself. The "performance" of such a system is usually related to data integrity, speed, compatibility, and display capabilities.
Based on the provided text, the document focuses on establishing substantial equivalence to a predicate device (Voyager PACS System) by demonstrating similar technological characteristics and indications for use. It does not describe a clinical study in the same way an AI diagnostic device would.
Therefore, many of the requested fields (like sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not provided in this type of 510(k) submission for a PACS system.
Here's an analysis based on the information provided, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria with numerical targets. The "acceptance" is based on demonstrating substantial equivalence to the predicate device in terms of technological characteristics and indications for use. The document implicitly accepts that if the device performs its core functions (storage, retrieval, display, compatibility) similarly to the predicate, it is acceptable.
- Reported Device Performance:
- "Fast transfer and access time (limited by the network bandwidth) for store and retrieval." (Qualitative statement)
- "Support concurrent storage and retrieval of multiple modalities and clients." (Functional statement)
- "Provides scalable storage architecture for images/report data and includes support for removable media solutions." (Functional statement)
- Support for DICOM protocol, web-based UI for admin, patient and study root query retrieval. (Functional statements)
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | |
| - DICOM compatibility & storage services | - "fully integrated DICOM Storage and DICOM Application Server, compatible with any DICOM modality" |
- "provides PACS services such as storage provider and query retrieve provider."
- "complete DICOM protocol support to handle all different types of DICOM images and reports." |
| - Query & Retrieval capabilities | - "supports patient root and study root query retrieval." - "The server and the client workstations communicate by using the DICOM protocol (DICOM C-Store or Query & Retrieve)." |
| - Image Communication & Display | - "Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations." - "The clients display the images by using medical imaging software such as a DICOM viewer or a radiology review workstation client software system." |
| - Integration with HIS/RIS | - "SntryPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records." |
| - Performance (Speed, Scalability, Concurrency) | - "Fast transfer and access time (limited by the network bandwidth) for store and retrieval." - "Support concurrent storage and retrieval of multiple modalities and clients."
- "Provides scalable storage architecture for images/report data and includes support for removable media solutions." |
| - System Administration | - "Web-based user interface for system administration." |
| Safety Considerations: | |
| - No patient contact / life support control | - "SntryPACS™ is a device that does not contact the patient, nor does it control any life sustaining devices." |
| - Human intervention for interpretation | - "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." |
| - Mammography specific use restrictions | - "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation." - "Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. For a PACS system, a "test set" in the diagnostic performance sense is not typically used or reported in this type of 510(k). The evaluation would likely involve system integration testing, performance benchmarking (e.g., for speed and throughput), and compatibility testing with various modalities, which are not detailed here as a "study" with a specific data sample.
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)
- Not applicable / Not provided. This information is relevant for devices that provide diagnostic output. Since SntryPACS™ is a data management and display system, it does not itself generate a "ground truth" that needs expert validation in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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. This is a PACS system, not an AI/CADe device. An MRMC study is not relevant for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a PACS system, not an AI/algorithmic diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided.
8. The sample size for the training set
- Not applicable / Not provided. This is relevant for machine learning models, which is not the primary function or focus of a PACS described in this document.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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).