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510(k) Data Aggregation
(29 days)
TeleScan
TeleScan® is a software application that is intended for use in receiving, manipulating, displaying, printing, and archiving ultrasound medical 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 diagnostic procedures. TeleScan® allows remote qualified radiologists and clinicians to provide a diagnosis remotely.
TeleScan® is used by trained medical professionals, including radiologists, sonographers, and clinicians, and may provide information to be used for diagnostic procedures. These individuals are referred to as healthcare workers for the purposes of this submission.
Like tele-radiology solutions, TeleScan® allows remotely located qualified radiologists and clinicians to provide a diagnosis. TeleScan® receives DICOM images transmitted ultrasound machines and displays the patient images. This includes cineloops (videos), 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.
TeleScan® software provides sonographers with tools to display patient measurements and observations (annotations). The application displays calculated gestational age and growth percentiles based on measurements of anatomical structures. Through a diagnostics function, the estimated fetal weight are calculated.
A draft patient report is prepared for further interpretation by medical professionals licensed to sign diagnostic reports, such as physicians, specialists, and nurse practitioners (providers).
TeleScan® is offered as software as a service (SaaS) and complies with and data-related laws, including but not limited to HIPAA.
The provided text describes a 510(k) submission for a medical device called TeleScan. While it mentions evaluation and validation studies, it does not provide specific quantitative acceptance criteria or detailed results of a comparative effectiveness study (like an MRMC study) in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device and software validation activities.
Therefore, many of the requested details, particularly the quantitative performance metrics and specifics of clinical study designs and outcomes (like MRMC results or standalone algorithm performance), are not present in the provided text. The information is more aligned with a regulatory submission outlining verification and validation activities rather than a detailed scientific paper on performance studies.
However, I can extract and infer some information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document emphasizes "equivalency" and "no differences in performance" compared to the predicate device, especially regarding the switch from PNG to JPG image format and the introduction of a specified output quality setting. Specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, AUC values) are not reported.
| Acceptance Criterion (Inferred from Text) | Reported Device Performance (Inferred from Text) |
|---|---|
| Diagnostic acceptability of new JPG usage specification and lower limit. | "demonstrate and support the safety and effectiveness of the proposed design update." "no differences in performance as reported with data provided by the physician user group." "continues to meet and satisfy user requirements and the indications for use statement." |
| Functionality of ultrasound output quality monitoring. | "continues to meet and satisfy user requirements and the indications for use statement." "The same functionality is carried for receiving, processing, manipulating, displaying, printing, and archiving ultrasound (US) images." |
| Clarity and adequacy of image quality warning messages/labels. | "clarity and adequacy of wording uses for image quality information that is displayed, the pop-up notification...and the permanent messaging added to images." (Implies satisfactory evaluation, but no quantitative metric). |
| Overall safety and effectiveness maintained with 2.0 software. | "The evaluations and resulting data support that safety and effectiveness are maintained with the proposed TeleScan with the 2.0 software." |
| Continued equivalency to predicate device. | "The results of the evaluations demonstrate the equivalency of the proposed TeleScan® with 2.0 software update for JPG image type use with a specification, lower limit, and image quality monitoring." "TeleScan® with 2.0 software performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions a "large group of prenatal sonographers" and a "large group of physicians" for evaluations. However, specific sample sizes (number of images, number of cases, number of subjects) are not provided. The data provenance (country of origin, retrospective/prospective) is also not stated. The nature of the study is framed as "evaluations" and "validations" for a design update rather than a de novo clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The text states that evaluations involved "a large group of physicians" for "diagnostic acceptability" and "physician diagnosis process acceptability." It also mentions "appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians" as users.
The expertise for "diagnosis" would typically fall to radiologists or other licensed medical professionals.
However, the exact number of experts for ground truth establishment for a test set and their specific qualifications (e.g., years of experience, board certification) are not explicitly provided.
4. Adjudication Method for the Test Set:
The document describes "sequential and side-by-side image reviews by healthcare professionals." This implies a comparison, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus, or independent adjudication) to establish a definitive ground truth where disagreements occurred.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with AI assistance versus without AI assistance was not performed or reported. The study described focuses on validating the updated software's performance (specifically the change to JPG and image quality monitoring) and its equivalency to the predicate, not on how an AI component improves human reader performance. The device TeleScan, as described, is a "Medical Image Management And Processing System," which contains "image processing and measurement tools" and facilitates "interpretation" and "diagnosis," but it is not presented as an AI-powered diagnostic aid that makes its own findings or enhances human detection capabilities in the way an MRMC study would typically evaluate.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance evaluation was not reported. The device is described as a system used "by appropriately trained healthcare professionals" for "receiving, manipulating, displaying, printing, and archiving ultrasound medical images" and providing "image processing and measurement tools." It's a tool for human use, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used:
The text implies that the "ground truth" or "reference standard" for evaluating the diagnostic acceptability and performance was based on the diagnoses and interpretations of a "large group of physicians". This sounds like expert consensus/opinion based on their review of the images. It does not mention pathology results, long-term outcomes data, or other definitive types of ground truth often used in diagnostic accuracy studies.
8. The Sample Size for the Training Set:
The document describes "non-clinical testing" and "design verification and validation" for a "design update," but it does not mention or specify a training set sample size. This is common for regulatory submissions where the focus is on validation of a completed software update rather than the initial development and training of an AI model.
9. How the Ground Truth for the Training Set was Established:
Since a training set is not explicitly mentioned or implied for an AI model in the context of this submission (which focuses on a software update for image management and processing), the method for establishing ground truth for a training set is not applicable/not provided. The "ground truth" discussed relates to the evaluation of the updated system's functionality and diagnostic acceptability by human experts.
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(29 days)
TeleScan
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.
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