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EchoGo Core is intended to be used for quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.

EchoGo Core 2.0 is a software application manufactured by Ultromics to provide a report of left ventricular cardiac function, in the form of secondary capture DICOM files and/or as a structured DICOM report, to aid interpreting physicians with diagnostic decision-making process. EchoGo Core 2.0 applies to ultrasound images of the heart (echocardiograms).

EchoGo Core 2.0 utilizes artificial intelligence (AI) for the operator-assisted automatic quantification of commonly measured echocardiographic metrics. Independent training, test and validation datasets were used for training and performance assessment of the device.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were formalized in terms of Root Mean Square (RMS) error against reference values generated using the comparator device, TomTec Arena TTA2. The text states that "the acceptance criteria were formalized such that EchoGo Core 2.0 would produce measures of left ventricular (LV) length, volume at end diastole (ED), and end systole (ES), ejection fraction (EF), stroke volume, cardiac output, global longitudinal strain (GLS) and segmental longitudinal strain (SLS) with an RMS error below a set, pre-determined threshold." While the exact pre-determined thresholds for acceptance are not explicitly listed in numerical values, the "Performance against the comparator device is summarised as follows," implying these are the reported performance values that met the (unspecified) acceptance thresholds.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 214 previously unseen studies.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is from Ultromics Limited in the United Kingdom.
  • Retrospective or Prospective: Retrospective. The study was described as a "formal retrospective, non-interventional validation study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the test set was established using a comparator device, TomTec Arena TTA2 (K150122), not human experts providing a direct ground truth. The acceptance criteria were formalized in terms of Root Mean Square (RMS) error against reference values generated using the comparator device. There is no mention of experts establishing ground truth for the test set; instead, the comparator device served as the reference.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was established by a comparator device rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size

No, an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance was not conducted or reported. The study focused on the device's performance against a comparator device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The primary performance study described seems to align with a standalone assessment against a comparator device. The text states, "EchoGo Core 2.0 would produce measures... with an RMS error below a set, pre-determined threshold" and "Performance against the comparator device is summarised as follows." This suggests the algorithm's output was directly compared to the output of the TomTec Arena TTA2.

However, it's crucial to note the device description also states: "EchoGo Core 2.0 requires an operator at key steps to confirm or relabel automatically labeled acquisition views (if required) and approve the left ventricle segmentations (contours) proposed by the AI." And "The operator will review the report produced and may be asked to approve cautions that are added to the report." This indicates that while the core performance metrics were evaluated in an algorithm-centric manner against a comparator, the device's intended use involves a "human-in-the-loop" for confirmation/approval steps. The reported performance metrics (RMS error) are likely for the algorithm's core measurements before potential human override, as the study compared them to an automated comparator device.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device (TomTec Arena TTA2, K150122). Values generated by the TomTec Arena TTA2 served as the reference values for calculating RMS error.

8. The Sample Size for the Training Set

The sample size for the training set is not specified in the provided text. The text only mentions that "Independent training, test and validation datasets were used for training and performance assessment of the device" and that "Test datasets were strictly segregated from algorithm training datasets."

9. How the Ground Truth for the Training Set was Established

The method for establishing ground truth for the training set is not explicitly detailed in the provided text. It only states that "Independent training, test and validation datasets were used for training and performance assessment of the device."

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