(39 days)
Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by modality and user; rotate images in 90-degree increments; flip image horizontally or vertically; customize display of on-screen user and patient demographics; sharpen, edge and blur filters; key image creation for communicating with other physicians, and multiple display support. Images can be displayed in any configuration or format the user specifies and associates with that specific user's profile. All display protocols and user configurable settings follow the user throughout the enterprise.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.
Emageon UV, Inc.'s Ultravisual™ software is integrated client-server software package comprised of features that were previously cleared in Vortex TM 510(k): K012097. The main difference is that the software will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as specific performance metrics. The underlying claim is substantial equivalence to a cleared predicate device. | The Ultravisual™ software is stated to have features previously cleared in Vortex™ (K012097) and will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user. |
| The device must not pose new issues of safety and effectiveness compared to its predicate. | The device is deemed substantially equivalent to the original Vortex 130 software, 510(k) K012097, and does not pose any new issues of safety and effectiveness. |
| Compliance with general controls and regulations (registration, listing, GMP, labeling, etc.) | The FDA's substantial equivalence determination allows marketing, subject to general controls and existing major regulations. |
| Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. | Explicitly stated as a condition for use. |
| Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA. | Explicitly stated as a condition for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set or a study with a test set for evaluating the performance of the Ultravisual™ software against defined performance criteria. The submission relies on substantial equivalence to a previously cleared device. Therefore, details about sample size or data provenance for a direct performance study are not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new performance study with a test set is described, this information is not available.
4. Adjudication Method for the Test Set
As no specific test set or performance study is described, adjudication method information is not available.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is described in the provided text. The submission focuses on substantial equivalence based on the predicate device's features and the addition of digital mammography display capability. Therefore, this information is not available.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone performance study for the Ultravisual™ software is described. The device's primary function is an image processing, communication, and visualization workstation intended for human interpretation. Therefore, this information is not available.
7. The Type of Ground Truth Used
As no new performance study is described, information on the type of ground truth used is not available. The basis for clearance is substantial equivalence.
8. The Sample Size for the Training Set
The document does not describe a training set as it relies on substantial equivalence and does not detail the development of a de novo algorithm requiring new training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, this information is not available. The device's validation and effectiveness are explicitly linked to the procedures documented in the predicate device's 510(k) (K012097), suggesting that any software development and testing followed a similar approach, focusing on functionality and safety rather than a new discriminative algorithm requiring a separate training set and ground truth.
§ 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).