(15 days)
The USWS-900A Ultrasound Workstation, when used by a qualified physician, is intended for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations.
The USWS-900A is a software package that may be applied to an existing workstation that is capable of receiving 2D, M-mode, spectral Doppler and 3D data sets via DICOM. This software consists of measurement packages that were cleared on the predicate device, SSH-880CV Artida Diagnostic Ultrasound System.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Toshiba USWS-900A, UltraExtend, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined criteria.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No specific performance metrics are mentioned for the USWS-900A itself. The document states it "does not offer new indications or functions that have not been cleared via the predicate devices" and that its measurement packages were cleared on a predicate device. This implies that its performance is presumed to be equivalent to the predicate devices, rather than being independently validated against new, quantitative acceptance criteria.
- The document is a regulatory submission, not a scientific publication detailing a clinical trial. Regulatory submissions for substantial equivalence often refer to existing clearances and general safety/effectiveness rather than presenting a full study design with detailed statistical analysis, sample sizes, and ground truth establishment methods for the new device.
Therefore, many sections of your request cannot be fulfilled based solely on the provided text.
However, I can extract the available information and explain what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device provides similar information to predicate devices. | The software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner similar to, or a combination of, the predicate devices. (This is a qualitative statement of equivalence rather than a quantitative performance metric). |
| Measurement Accuracy (Implied via predicate): Measurement packages perform as cleared on the predicate device. | The software consists of measurement packages that were cleared on the predicate device, SSH-880CV Artida Diagnostic Ultrasound System. (No specific quantitative performance metrics for these packages are stated for the USWS-900A itself, relying on prior clearance of the predicate). |
| Safety and Effectiveness: Designed and manufactured in compliance with QSR; no new safety concerns or functions. | This software package is designed and manufactured in compliance with the Quality System Regulation. This device does not offer new indications or functions that have not been cleared via the predicate devices, nor does it offer functions that are not already available through 510(k) cleared devices that are commercially available in the U.S. (This is a statement of compliance and absence of novel risks, not a measurable performance criterion). |
| Intended Use: Capable of displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations. | The USWS-900A is a software package that may be applied to an existing workstation that is capable of receiving 2D, M-mode, spectral Doppler and 3D data sets via DICOM. The intended use is for displaying and analyzing ultrasound images for medical diagnosis in cardiac and general examinations. (This confirms functionality of displaying/analyzing data types and adherence to intended use, but no performance metrics are given). |
The study proving the device meets the (implied) acceptance criteria is the 510(k) Pre-Market Notification process itself, which relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than a new standalone clinical study with specific performance endpoints for this particular software upgrade.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document does not describe a new clinical test set for this 510(k) submission.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified, as no new test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This device is an ultrasound workstation software package, not an AI-assisted diagnostic tool in the sense of comparing human reader performance with and without AI. It provides measurement packages cleared on a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No specific standalone performance study for the USWS-900A software package (e.g., algorithm accuracy or precision for its measurements) is described in this document. The existing measurement packages are stated to have been cleared on the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified, as no new clinical study with a defined ground truth method is described for this specific submission. Any ground truth establishment would have occurred during the clearance process of the predicate device's measurement packages.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development of a new machine learning algorithm with a training set. It refers to established measurement packages from a predicate device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as this document does not describe the development of a new machine learning algorithm with a training set.
§ 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).