(75 days)
This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.
Retrieval and storage of both passive and active ultrasound images
Analysis of ultrasound images
Reconstruction and display of three dimensional images.
The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, and connecting cables.
This device, the Toshiba PowerView Ultrasound Workstation, UIDM-400A, is a Picture Archiving and Communications System (PACS) and, as such, there are no specific performance acceptance criteria or a dedicated study described to "prove" the device meets such criteria in the provided documents.
The submission is a 510(k) for a new product, and the claim for substantial equivalence relies on comparison to existing predicate devices (Toshiba Workstation, UIWS-300A, Dicomit Image Manager, Tomtec Echo-Scan). The primary focus of the 510(k) process for this type of device is often on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to legally marketed predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: Device performs functions similar to predicate devices (capture, storage, review, analysis of ultrasound images, 3D image reconstruction). | "The user features of the UIDM-400A PowerView Ultrasound Workstation are similar to the functions included in the three predicate device does not offer any new functions that have not received previous market clearance from the Agency." |
| No New Safety or Efficacy Concerns: Device does not introduce new safety or efficacy issues compared to predicates. | "This system poses no new safety concerns or efficacy concerns that were not addressed in previous submissions." |
| Verification and Validation Testing: Equivalent to testing reported in previous 510(k) submissions for similar software components. | "The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions." (Note: Specific parameters or results of this testing are not provided.) |
| Compliance with General Controls: Adherence to annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." And, "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
| Manufacturing Standards: ISO-9001 certified and follows Quality System Regulations. | "The manufacturing facility is ISO-9001 certified and follows the Quality System Regulations as administered by the Food and Drug Administration." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The provided documents describe a 510(k) submission for a PACS workstation, not a clinical study on a diagnostic algorithm. There is no mention of a specific "test set" of patient data in the context of diagnostic performance. The verification and validation testing mentioned refers to software and system functionality testing, not clinical performance studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As above, there is no mention of a clinical test set requiring expert ground truth establishment for diagnostic performance.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The documents do not mention or describe any MRMC comparative effectiveness study. This type of study is typically performed for diagnostic devices where human interpretation plays a significant role and the AI aims to assist or replace that interpretation. This device is a workstation for viewing and analyzing images, not an AI-powered diagnostic algorithm in itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a workstation, which is inherently designed for human interaction ("human-in-the-loop"). It is not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for this device would relate to its functional correctness (e.g., does it accurately display images, does it perform measurements as expected) and software quality, validated against technical specifications and predicate device equivalence, rather than a clinical outcome.
8. The Sample Size for the Training Set
Not applicable. This device is a workstation for image management and analysis, not an AI model that undergoes a "training" process with a dataset of images.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device in the AI sense.
Summary of the Study (as described in the 510(k) submission):
The "study" or justification for clearance in this context is a benchmarking and equivalence assessment against predicate devices, coupled with internal verification and validation (V&V) testing for software and system functionality.
- Objective: To demonstrate that the PowerView Ultrasound Workstation, UIDM-400A, is substantially equivalent to legally marketed predicate devices and does not raise new questions of safety or effectiveness.
- Methodology:
- Comparison to Predicate Devices: The submission highlights that the UIDM-400A offers similar user features and no new functions compared to the Toshiba Workstation (UIWS-300A), Dicomit Image Manager (K990248), and Tomtec Echo-Scan (K963807). This is a qualitative assessment of functional equivalence.
- Verification and Validation (V&V) Testing: The document states that "The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions" for the various vendor programs comprising the software. This implies internal engineering and software quality assurance testing (e.g., unit testing, integration testing, system testing, performance testing) to ensure the device performs as intended and meets its specifications. The specific details of this V&V are not provided in this summary.
- Safety Considerations: The claim is made that the system poses no new safety concerns, attributed to it being comprised of a standard personal computer and previously cleared software components.
- Manufacturing Standards: Compliance with ISO-9001 and Quality System Regulations is stated.
Conclusion:
The provided documents do not detail a clinical performance study with patient data, acceptance criteria related to diagnostic accuracy, or an AI algorithm’s performance. Instead, they describe a 510(k) submission focused on demonstrating substantial equivalence for a medical image management and analysis workstation by comparing its features and safety aspects to existing, cleared devices and referencing standard software verification and validation practices.
§ 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).