(29 days)
TeleScan™ is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data. Images and data can be stored, communicated, and displayed within the system or across computer systems. TeleScan™ provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis.
TeleScan™ is used by appropriately trained healthcare professionals. including radiologists, sonographers, technologists, and clinicians, in a medical facility. TeleScan™ may provide information to be used for screening and diagnostic procedures. TeleScar™ allows remote qualified radiologists and clinicians to provide a diagnosis remotely.
TeleScan™ is used by trained medical professionals, including radiologists, sonographers, technologists, and clinicians, and may provide information to be used for screening and diagnostic procedures. These individuals are referred to as Healthcare Workers (HCWs) for the purposes of this submission.
Similar to tele-radiology solutions, TeleScan™ allows remote, qualified radiologists and clinicians to provide a diagnosis remotely. TeleScan™ receives ultrasound DICOM images transmitted from leqally marketed ultrasound machines and displays images. This includes videos (cineloops), diagnostics tools for annotation, and a simplified workflow for report creation. TeleScan™ is compatible with ultrasound images acquired by appropriately trained healthcare professionals in medical facilities.
The software provides the Sonographer tools to display patient measurements and observations. The application also calculates gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated due date and estimated fetal weight is calculated.
The report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports such as physicians, specialists, and nurse practitioners. For the purposes of this submission, these individuals are referred to as "Physicians".
TeleScan™ is offered as software as a service (SaaS) and complies with digital health and data related laws, including but not limited to HIPAA.
Here's a summary of the acceptance criteria and study information for the TeleScan™ device based on the provided document:
This device (TeleScan™) is a medical image management and processing system for ultrasound images. The 510(k) submission states that no clinical studies were performed to support substantial equivalence. The performance testing conducted was non-clinical. Therefore, there are no specific performance criteria or a study that directly proves the device meets those criteria in a clinical setting as would be
expected for AI/ML devices that perform diagnostic, screening or prognostic functions.
The document indicates "The performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate (Unifi Workspace, K190694) for specific application features."
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) from clinical studies are provided, the "acceptance criteria" here are inferred from the substantial equivalence claim based on functional and technical comparisons to predicate devices. The device's "performance" is stated as being equivalent in these non-clinical aspects.
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Ability to receive, process, manipulate, display, print, and archive ultrasound medical images and data. | Demonstrated equivalent performance to predicate devices (Unifi Workspace, K190694, and Viewpoint 6, K203677) for these functions. |
| Measurement & Calculation | Ability to calculate gestational age, growth percentiles, estimated due date, and estimated fetal weight based on anatomical measurements. | Functionally equivalent to the reference device (Viewpoint 6, K203677). |
| Image Processing Tools | Provision of image viewing and manipulation tools (Window/Level, Pan, Zoom, Measure, Annotate, Cine, etc.). | Functionally equivalent to predicate and reference devices. |
| Reporting Capabilities | Ability to enable quick diagnostic reporting with standardized terminology. | Functionally equivalent to predicate and reference devices. |
| Safety & Effectiveness | No new issues of safety or effectiveness compared to predicate devices. | Non-clinical testing demonstrated equivalent safety and effectiveness. |
| Software Level of Concern | Moderate | TeleScan™ is a Moderate Level of Concern software, matching both predicate and reference devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described is "nonclinical testing," "bench testing, including functional testing and usability testing." No details on the sample size or provenance of images/data used for this non-clinical testing are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As no clinical test set requiring expert ground truth was performed, this information is not provided.
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set was used, no adjudication method 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
No. The document explicitly states: "No clinical studies have been performed to support substantial equivalence." TeleScan™ is described as a medical image management and processing system with various tools, not an AI/ML diagnostic algorithm that directly assists human readers in such a way that would be assessed through an MRMC study comparing performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. The device is a "software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving ultrasound medical images and data," and "provides various image processing and measurement tools to facilitate the interpretation of ultrasound DICOM medical images and enable diagnosis." It is not a standalone diagnostic algorithm that operates without human interaction or interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Given the nature of the non-clinical testing and the absence of clinical studies, no "ground truth" for diagnostic accuracy (e.g., from pathology or expert consensus on clinical cases) was established or used. The "ground truth" for functional testing would typically involve verifying software outputs against expected calculations or displays.
8. The sample size for the training set
Not applicable. The document describes TeleScan™ as a medical image management and processing system with tools, not an AI/ML model that would require a "training set" in the conventional machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML model.
§ 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).