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The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems.

Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

The Caption Guidance software is a radiological acquisition and/or optimization guidance system that provides real-time guidance to the users during acquisition of echocardiography to assist them in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.

Caption Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include:

• 1. Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below.
• 2. Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view.
• 3. Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it.
• 4. Save Best Clip: This feature continually assesses clip quality while the user is scanning and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.

The Caption Guidance software was trained using echocardiographic clips from studies performed by trained sonographers. The ideal probe pose for each cardiac view was used to determine the Prescriptive Guidance for maneuvering the probe to the ideal pose.

The Caption Guidance software is labeled for use with the Terason uSmart 3200t Plus, an FDA 510(k) cleared (K150533) ultrasound system. Caption Guidance is installed on the third-party ultrasound system. The user has access to both the Terason user interface (UI) and the Caption Guidance UI and will be able to switch between the two.

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

Acceptance Criteria and Device Performance

The primary acceptance criteria for the Caption Guidance device focused on the ability of medical professionals without specialized echocardiography training (represented by Registered Nurses, RNs) to acquire echocardiographic exams of sufficient image quality for clinical assessment.

Table of Acceptance Criteria and Reported Device Performance (Pivotal Study - RN Users):

The text explicitly states: "The four primary endpoints were satisfied and demonstrated the clinical utility of Caption Guidance for users without specialized echocardiography training." This indicates that the reported percentages met their predetermined success criteria.

Study Details: Pivotal (Nurse) Study

2. Sample Size and Data Provenance:
* Test Set Sample Size: 8 Registered Nurses (RNs) each completed scans of 30 patients, resulting in a total of 240 patient studies (8 RNs * 30 patients).
* Data Provenance: The study was a prospective clinical study conducted with US-based participants (implied by the FDA De Novo classification and the mention of Northwestern Memorial Hospital for the Human Factors study, which typically suggests local clinical trials).

3. Number of Experts and their Qualifications for Ground Truth:
* Number of Experts: Five (5) expert cardiologists.
* Qualifications: "Expert cardiologists" are described as providing independent assessments. While specific years of experience aren't stated, the term "expert" implies significant experience and board certification, aligning with qualifications needed for interpreting echocardiograms.

4. Adjudication Method for the Test Set:
* The panel of five (5) expert cardiologist readers independently provided assessments. The text does not describe an explicit adjudication method like "2+1" or "3+1" to resolve disagreements. Instead, it seems the data presented (e.g., percentages of sufficient quality) are based on a consensus or aggregated proportion from these independent assessments (likely using an MRMC statistical approach, as indicated by "MRMC CI"). "In addition, each of the cardiologist readers were asked to provide a repeat assessment on a certain percentage of the exams or clips they reviewed in order to assess intra-grader variability." This suggests independent review was a cornerstone, with variability being a key consideration rather than forced consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* Yes, a MRMC study was done, but not to directly compare human readers with AI vs. without AI assistance regarding effectiveness gains.
* The pivotal study used an MRMC design to evaluate the performance of RNs using Caption Guidance against a control arm where trained sonographers acquired images unassisted. The MRMC primary endpoints focused on the proportion of sufficient quality scans achieved by RNs with Caption Guidance.
* Effect Size of Human Readers Improve with AI vs. without AI Assistance: This specific metric (improvement of human readers who already know how to scan when assisted by AI) was not explicitly reported as a primary endpoint or effect size in the pivotal study results section.
* However, a descriptive "Specialist (Sonographer) Study" was conducted with 3 expert cardiologists. This study indicated that "sonographers obtained diagnostic quality images in a high proportion of clips from both study and control exams, demonstrating comparable image quality in clips acquired using Caption Guidance compared to unassisted acquisition." This implies that for already trained sonographers, the AI did not significantly improve their image quality but maintained comparability. The key benefit demonstrated by the pivotal study was enabling untrained users to achieve high-quality images.
* The pivotal study showed that RNs using Caption Guidance could achieve clinical assessments with high success rates, implicitly demonstrating a significant improvement for these untrained users compared to their performance without the device (which would presumably be very low or non-existent for standard views).

6. Standalone (Algorithm Only) Performance:
* Yes, standalone algorithm performance testing was done. The section "Algorithm Performance Testing" details this:
* "The Caption Guidance algorithm was tested for the performance of the supported features: Quality Meter, Auto-Capture, and Save Best Clip."
* Metrics included "Frame-level prediction of the current pose of the probe, as compared to the ideal pose," "Relative image quality prediction," and "Auto-Capture of clinically-acceptable images and clips."
* It also tested "Frame-level PG prediction of the probe maneuver needed to acquire an image/frame" and "Clip-level PG prediction."
* The text notes these results "provide evidence in support of the functionality of Caption Guidance fundamental algorithms" and "demonstrated a low-level verification of the algorithms."

7. Type of Ground Truth Used:
* For the pivotal study, the ground truth was primarily expert consensus (or independent assessment for subsequent aggregation/MRMC analysis) by expert cardiologists using the American College of Emergency Physicians (ACEP) scale for echocardiography quality for individual clips, and global assessment of "sufficient information to assess ten clinical parameters" for patient studies.
* Additionally, quantitative expert measurements by sonographers ("PLAX Sonographer Measurements") served as ground truth for assessing measurability and variability of linear measurements.
* For the initial algorithm training, "The ideal probe pose for each cardiac view was used to determine the Prescriptive Guidance," implying a form of expert-defined ideal states/positions as ground truth.

8. Sample Size for the Training Set:
* The document states: "The Caption Guidance software was trained using echocardiographic clips from studies performed by trained sonographers." A specific sample size for the training set is not provided in the given text.

9. How the Ground Truth for the Training Set Was Established:
* "The Caption Guidance software was trained using echocardiographic clips from studies performed by trained sonographers."
* "The ideal probe pose for each cardiac view was used to determine the Prescriptive Guidance for maneuvering the probe to the ideal pose."
* This implies the ground truth for training data likely involved:
* Labeled echocardiographic clips: Experts (sonographers) provided the "correct" (diagnostic quality, specific view) clips.
* Expert definition of "ideal probe pose": This would serve as the target for the prescriptive guidance and quality meter. This likely involved expert sonographers demonstrating and labeling ideal probe positions and maneuvers for each cardiac view.

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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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