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ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.

ASCEND Image Viewer is for prescription use only.

The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.

The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:

• . 2D
• Color Doppler
• M-mode
• . Spectral Doppler (Pulsed Wave and Continuous Wave)

The ASCEND Image Viewer provides Cine play review and control.

Standard Review supported study types include:

• TTE
• TEE
• Cath
• . Stress Echo
• Vascular

Supported Measurements include:

• Linear
• . Volume (method of discs)
• Velocity time integral
• Pressure half-time
• . Area
• Time
• Velocity
• Angle (measurement of two lines with a common vertex drawn on the image) .

The user can make measurements which persist for later use within the ASCEND Image Viewer.

Here's a breakdown of the acceptance criteria and study information for the ASCEND Image Viewer, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the ASCEND Image Viewer as a software-only medical device for displaying and measuring echocardiograms. The comparison is made against a predicate device, TomTec-Image Arena (K132544). The clinical testing and "Brief Discussion of Test Results Submitted: Bench Testing" section indicate that the device performed effectively and was found to be substantially equivalent to the predicate where functionality intersected.

However, the document does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., accuracy of measurements, speed of image display) or provide reported numerical performance values for the ASCEND Image Viewer in a table format. Instead, the acceptance is based on demonstrating substantial equivalence in functionality, intended use, technological characteristics, and typical users, along with adherence to design specifications and risk assessment.

The document states:

• "The Graphic User Interface conforms to the ASCEND Image Viewer functional specification."
• "The comparison ASCEND Image Viewer with the predicate devices shows that the ASCEND Image Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices."
• "Verification and validation activities ensure that the design specifications are met, and that ASCEND Image Viewer does not introduce new issues concerning safety and effectiveness."

Given this, I will describe the characteristics compared rather than specific quantitative acceptance criteria and reported performance, as those are not provided in a measurable format.

Study Information

The document describes both Bench Testing and Clinical Testing.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of cases or images for either bench or clinical testing.
   • Data Provenance:
     • Bench Testing: The test plan covered "all aspects of the functionality, exercising every user interface, all menus and submenus, as well as the measurement tools." No specific data type or origin is given for the bench tests beyond general functional and DICOM compliance verification.
     • Clinical Testing: The testing occurred "in US city-hospital environments." The data used would have been clinical echocardiograms from these environments. The studies appear to be prospective in the sense that the device was evaluated during its development cycle with "clinical testers" in a real-world setting, but it's not a formal prospective clinical trial for efficacy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Clinical Testing: The test involved "resident cardiologists, cardiology fellows, and sonographers." The number of these experts is not specified. Their role was to assess the effective performance of the device's intended use and its substantial equivalence to the predicate. The document doesn't explicitly state they established a "ground truth" for specific diagnostic findings, but rather that they evaluated the device's functional performance in a clinical context.
   • Bench Testing: No experts are mentioned for ground truth establishment during bench testing.

3. Adjudication method for the test set:

   • Not specified. The clinical testing describes users evaluating the device's performance, rather than an adjudication process for a diagnostic outcome.

4. 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 formal MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The ASCEND Image Viewer is described as an image viewing and measurement tool, not an AI-assisted diagnostic algorithm in the sense of providing automated interpretations. The comparison was to a predicate image viewer.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device itself is a "software-only medical device intended for use by trained clinicians to display medical images." Its performance is inherently linked to human interaction (displaying images and making measurements). The bench testing would represent a form of standalone functional testing of the algorithm's capabilities (e.g., DICOM compliance, measurement calculations), but not an evaluation of its diagnostic performance in a "standalone" context separate from clinical use. The clinical testing explicitly involved "trained clinicians."

6. The type of ground truth used:

   • For Bench Testing: "Ground truth" was conformity to the ASCEND Image Viewer functional specification and DICOM standard compliance. Risk analysis according to ISO 14971 was also a benchmark.
   • For Clinical Testing: "Ground truth" was implicitly based on the consensus or clinical judgment of the "resident cardiologists, cardiology fellows, and sonographers" during their use of the device, where they determined if it "performed effectively its intended use" and was "substantially equivalent" to the predicate. It was an evaluation of the tool in practice rather than against a predefined diagnostic gold standard (e.g., pathology report) for individual cases.

7. The sample size for the training set:

   • Not applicable/Not provided. The ASCEND Image Viewer is described as an image viewing and measurement system, not a machine learning or AI algorithm that would typically require a "training set" in the context of image analysis. The functionality described (display, measurements, Cine play) suggests a deterministic software rather than one that learns from data.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set for a machine learning model is mentioned.

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