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

EchoGo Core is a standalone software application that automatically measures standard cardiac parameters including Ejection Fraction (EF), Global Longitudinal Strain (GLS), and Left Ventricular (LV) volume. EchoGo Core provides a service to calculate those values and provide a report back to the clinician. EchoGo Core analyzes echocardiogram cardiac parameters. An echocardiogram is performed using standard echocardiograms protocols. The anonymized echocardiogram dataset is transferred to Ultromics and once received the images are processed through the application's workflow. Once the technical QC has been performed, the automated contour detection of the endocardium of the LV is reviewed and approved by trained operators. Identifying and outlining the LV is standard practice in echocardiography and present in many other cleared devices, including the predicate device TomTec Arena TTA2 (K150122). In the proposed device, an auto-contouring algorithm places points around the LV that sufficiently capture the LV shape. These contours are used in calculations for geometric parameters. As with the TomTec Arena TTA2, the following parameters are calculated for inclusion in the report: EF: calculated from Simpson's Biplane Method (SBM) LV Volumes. GLSAVG: standard calculations, averaged from 2 chamber and 4 chamber views. LV volume: SBM calculated left ventricular volumes. A worksheet is automatically generated from the calculated parameters which is returned to the interpreting clinician. This report is intended as an additional input to standard diagnostic pathways and is only to be used by qualified clinicians.

Here's a breakdown of the acceptance criteria and study details for the EchoGo Core device, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The exact numerical thresholds for "Below a set threshold" are not explicitly stated for all parameters, but the reported performance met these unquantified thresholds.)

2. Sample Size and Data Provenance for Test Set

• Sample Size: 378 previously acquired studies.
• Data Provenance: The text does not explicitly state the country of origin. It indicates the data was "previously acquired studies." The study was a "retrospective, non-interventional validation study."

3. Number of Experts and Qualifications for Ground Truth

The text states that the reference values, against which EchoGo Core was compared, were "generated using TomTec Arena TTA2 by a range of users (echocardiographers and cardiologists)." It also mentions that "EchoGo Core volume, ejection fraction and global longitudinal strain measurements were produced by a range of users (echocardiographers and cardiologists)."

• Number of Experts: "a range of users" (not a specific number provided).
• Qualifications of Experts: Echocardiographers and cardiologists.
• Note: The ground truth itself was not established by these experts directly, but rather by the predicate device (TomTec Arena TTA2) operated by these experts.

4. Adjudication Method for the Test Set

The text does not describe an explicit adjudication method for the test set. The primary comparison was between the EchoGo Core's output and the values generated by the predicate device (TomTec Arena TTA2). There's no mention of multiple experts independently evaluating and then adjudicating discrepancies for the ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a formal MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance. The study described focuses on the standalone performance of the EchoGo Core device compared to a predicate device.

However, the document does make a comparison related to user interaction with contours:

• "Inter and intra-operator variability (0% bias and RMSE) was eliminated" for EchoGo Core.
• "inter and intra-operator variability remained for the predicate, TomTec Arena TTA2 (5.3-12.0% and 2.5-4.7% RMSE for EF and GLS, respectively)."
• "manual contour editing was required in up to 100% of cases processed through the predicate, while contour rejection was required in up to 29% of cases processed through EchoGo Core."

This indicates an implicit benefit in eliminating operator variability, but it's not quantified in terms of improved human reader performance with AI assistance in a diagnostic task.

6. Standalone Performance Study

Yes, a standalone study was performed. The entire performance testing section describes the EchoGo Core device calculating parameters independently and then comparing these calculated values to those produced by the predicate device (TomTec Arena TTA2). The performance metrics (RMSE) directly refer to the algorithm's output.

7. Type of Ground Truth Used

The ground truth for the performance study was the measurements derived from the predicate device, TomTec Arena TTA2, operated by echocardiographers and cardiologists. This can be considered a form of "expert consensus/device-derived reference," where the extensively validated predicate device, used by experts, served as the reference standard.

8. Sample Size for the Training Set

The document explicitly states: "Test datasets were strictly segregated from algorithm training datasets." However, it does not provide the sample size for the training set.

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

The document states: "Test datasets were strictly segregated from algorithm training datasets." While it confirms segregation, it does not provide information on how the ground truth for the training set was established.

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