(88 days)
UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
UniWeb™ will be used to display FFDM (Full Field Digital Mammography) postprocessed images in DICOM for presentation only formats.
UniWeb™ will NOT utilize digitized film images, only images from FFDM modalities.
UniWeb™ will be utilized for interpretation of mammography images in a primary diagnostic setting.
UniWeb™ will be utilized only on FDA approved monitors used for mammography.
Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians.
This product will only use lossless compression or no compression when displaying mammography images.
For image diagnosis, this device can only be used by trained professionals.
UniWeb™ is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the UniWeb™ device:
This document is a marketing clearance letter for a Picture Archiving and Communications System (PACS) named UniWeb™, version 5.0. It is not a detailed study report or clinical trial summary. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving performance against them is not present in this specific document.
The document primarily focuses on the device's substantial equivalence to a legally marketed predicate device, its intended use, and regulatory compliance. It does not contain primary data from performance studies.
However, based on the "Indications for Use Statement," we can infer some operational acceptance criteria for the device itself and constraints on its use, rather than strict performance metrics.
Acceptance Criteria and Device Performance (Inferred from "Indications for Use")
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Image Handling: | |
| Receives digital images from various sources | Stated capability: Receives images from digital mammography, MR, ultrasound, CT scanners, R/F Units, computed & direct radiographic devices, secondary capture, scanners, imaging gateways, or other imaging sources. |
| Stores, communicates, processes, and displays images and data within the system or across a network | Stated capability: Images and data can be stored, communicated, processed and displayed within the system and/or across a computer network at distributed locations. |
| Displays FFDM post-processed images in DICOM for presentation only formats | Stated capability. |
| Will NOT utilize digitized film images | Stated limitation. |
| Image Quality/Compression: | |
| Uses lossless compression or no compression for mammography images | Stated as a requirement for displaying mammography images. |
| Clinical Use: | |
| Utilized for interpretation of mammography images in a primary diagnostic setting | Stated intended use. |
| Utilized only on FDA approved monitors used for mammography | Stated requirement for use. |
| For image diagnosis, can only be used by trained professionals | Stated user requirement. |
| User Base: | |
| Typical users are trained professionals (physicians, nurses, technicians) | Stated as the typical user base. |
Missing Information and Explanation:
The provided document (an FDA 510(k) clearance letter) does not contain the following information:
- Sample size used for the test set and the data provenance: This document does not describe a specific test set or clinical study data. The 510(k) pathway often relies on demonstrating substantial equivalence to a predicate device, which may involve engineering benchmarks rather than extensive clinical efficacy trials.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as detailed ground truth establishment for a specific test set is not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as a test set and ground truth adjudication are not described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not described. PACS systems typically demonstrate equivalence for image display and handling rather than comparative diagnostic performance studies like those for AI algorithms.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a PACS for display and management of images. It is not an AI algorithm performing diagnosis independently.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed ground truth is not described.
- The sample size for the training set: Not applicable. This PACS is not an AI/ML device that requires a training set in the conventional sense. Its "training" would be more akin to software development and testing based on DICOM standards and image processing algorithms.
- How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.
Summary regarding the "study that proves the device meets the acceptance criteria":
The provided text does not describe a specific study that proves the UniWeb™ device meets detailed performance acceptance criteria in the manner one would expect for a diagnostic AI algorithm. Instead, the FDA's 510(k) clearance process determined that the device is "substantially equivalent" to legally marketed predicate devices for its stated "Indications for Use." This equivalence typically relies on demonstrating that the device performs as intended and introduces no new safety or effectiveness concerns compared to existing devices. The "Indications for Use" statement implicitly defines the scope within which the device is deemed safe and effective based on this equivalence.
§ 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).