(62 days)
The StatPacs™ is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatView™ with the Exam Manager™ application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacs™, is not to be used for mammography imaging.
The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis. Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.
This submission package for StatPacs™ refers to a Picture Archiving and Communications System (PACS) software. A PACS is a system that allows for the storage, retrieval, distribution, and presentation of medical images. These systems are well-established, and the regulatory filing here is for a new version or offering of such a system. The key to understanding this document is recognizing that the primary claim is for substantial equivalence to existing PACS devices. This means the manufacturer is arguing that their device is so similar to previously cleared devices (predicates) that it doesn't raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" and "study" information you're asking for in the context of an AI-powered device or a study proving device performance in a clinical diagnostic sense, is not present here. This document primarily focuses on demonstrating that the StatPacs™ system behaves like other PACS systems already on the market. There is no mention of AI, specific diagnostic performance metrics like sensitivity/specificity, or clinical studies designed to show a performance benefit.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Algorithm Performance:
This submission does not contain specific "acceptance criteria" or reported "device performance" in the sense of diagnostic accuracy or clinical utility metrics (e.g., sensitivity, specificity, AUC) for an AI algorithm. The device, StatPacs™, is a PACS software, and its claimed performance is its ability to function as a PACS system, similar to its predicate devices. The acceptance criteria for such a device are typically related to:
- Functionality: Transmit, receive, display, and store 2D/3D images.
- Connectivity: Interface with various modalities (CT, MRI, US, CR, DR, NM, PET, digitized films) via industry standards (DICOM, LAN/WAN, VPNs).
- Image Handling: Image compression and encryption adhering to standard industry protocols.
- Safety & Effectiveness: No new issues of safety or effectiveness compared to predicate devices.
The "reported device performance" is essentially that it meets these functional requirements and is substantially equivalent to predicate PACS systems. There is no standalone (algorithm-only) performance study described because it's a PACS system, not a diagnostic AI algorithm.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This 510(k) submission does not describe a clinical study with a test set of patient cases to evaluate diagnostic performance. The substantial equivalence argument relies on comparing the technical and functional characteristics of StatPacs™ to predicate PACS devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no clinical diagnostic performance study is described, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. No test set or corresponding adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done or reported in this document. The submission is for a PACS system, not an AI-assisted diagnostic tool that would typically undergo such a study to assess human reader improvement.
7. Type of Ground Truth Used:
Not applicable. No ground truth is established or used in the context of diagnostic performance for this submission, as it's a PACS system.
8. Sample Size for the Training Set:
Not applicable. As this is not an AI diagnostic algorithm, there is no mention of a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. Since there is no training set mentioned, there is no information on how ground truth for it would be established.
Summary regarding the nature of the submission:
This 510(k) summary is for a Picture Archiving and Communications System (PACS). It emphasizes software-based functionality for image handling (transmit, receive, display, store) and connectivity with various medical imaging modalities. The core of the submission is the claim of substantial equivalence to existing, legally marketed PACS devices (predicates). This means the StatPacs™ system behaves in a functionally similar manner to already approved PACS, rather than introducing new diagnostic capabilities that would require a detailed clinical performance study with acceptance criteria, test sets, ground truth, and AI-specific evaluations. The FDA's letter confirms substantial equivalence based on the provided information, not on a clinical performance study demonstrating unique diagnostic accuracy.
§ 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).