(25 days)
The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.
The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.
The Hologic Secur View DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive at least two high-resolution gray scale displays (FDA cleared for Mammography), a PC mouse, a keyboard and an optional dedicated workflow keypad.
The software accepts standard or multi-frame mammography images that have been created according to the "FOR PRESENTATION" specification of the DICOM Standard with no compression or using lossless compression. Image processing is external to the SecurView DX software.
The software accepts multimodality images of US, MR, DR, CR, SC, CT, PET, and other DICOM formats for display and manipulation on the high resolution 5 MP gray scale displays or on a color 2 MP display in 2-D or 3-D view.
The SecurView DX software can be used in a single or in a multi-workstation configuration.
The minimum computer requirements to run the Secur View DX software are: Windows XP® Operating System Intel CPU with a clock rate of 2.0 GHz or greater 2.0 GB RAM or greater 140 GB Hard drive or greater, operating at 160 Mbs or greater CD-ROM/R 10/100 Base TX Network Interface
The provided document is a 510(k) summary for the Hologic SecurView DX, a software product for viewing and manipulating digital radiology images, primarily mammograms. The submission is a "Special 510(k)," meaning it's a modification to an already cleared device (K041555). Therefore, the study presented focuses on demonstrating substantial equivalence to the predicate device rather than establishing de novo performance criteria through a new clinical effectiveness study.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in the typical sense of a de novo device submission (e.g., specific sensitivity or specificity targets). Instead, the acceptance criterion for this Special 510(k) is substantial equivalence to its predicate device (SecurView DX K041555).
The reported device performance is demonstrated through its functional similarity and compliance with relevant standards.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (K041555) | - Maintains the same intended use. |
| - Similar computing requirements (CPU, RAM, Hard drive). | |
| - Compatible with the same network interface and peripheral devices (keyboard, workstation keypad, bar code reader). | |
| - Software developed under ISO 13485 and 21 CFR Part 820 Quality System. | |
| - Complies with ACR/NEMA DICOM Standard (PS 3.1-3.18 Set). | |
| - Displays and manipulates DICOM images for interpretation by trained personnel. | |
| - Functionality allows for recovery from partial/failed transmissions. | |
| - Incorporates passwords for security. | |
| - Hazards studied and controlled by a Risk Management Plan. | |
| - Differences are minor (e.g., Windows OS upgrade, DVD-R change, optional color display) and do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set or clinical study with patient data to evaluate diagnostic performance. As a Special 510(k) for a software modification, the focus is on verification and validation (V&V) of the software and hardware changes, demonstrating that the modified device performs as intended and is equivalent to the predicate. The "study" here is primarily an engineering and quality systems V&V process rather than a clinical trial.
Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided because such a study was not deemed necessary for this type of submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Since no clinical study with a test set of patient cases is described, there is no information provided on experts establishing ground truth for such a dataset. The "experts" involved would have been the Hologic engineering and quality assurance teams validating the software modifications.
4. Adjudication Method for the Test Set
As there is no described test set of patient cases, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not report on a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is a Special 510(k) focused on demonstrating substantial equivalence through software and hardware modifications, not on measuring the comparative effectiveness of human readers with or without AI assistance. The device itself is a viewing workstation, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The SecurView DX is a "Picture archiving and communication system" and a "multi-modality review workstation software." It is designed for "display, manipulation and interpretation of lossless compressed or non-compressed mammographic images using FDA cleared displays for screening and diagnostic mammography." This explicitly describes a human-in-the-loop device. Therefore, no standalone (algorithm-only) performance study was conducted or is relevant for this device's intended use.
7. Type of Ground Truth Used
Given that no clinical study with patient data is described, formal "ground truth" in the clinical sense (e.g., pathology, outcomes data) was not used for this submission to establish diagnostic accuracy. The ground truth for this submission relates to the functional correctness and compliance of the software and hardware modifications, established through internal testing, validation against DICOM standards, and verification against the predicate device's specifications.
8. Sample Size for the Training Set
No training set is mentioned because the SecurView DX is a software workstation for displaying and manipulating images, not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm mentioned, this information is not applicable.
§ 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).