Search Results

Ask a specific question about this device

Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.

The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Ejection Fraction ≤ 40% , who may use the result in conjunction with their own evaluation and clinical judgment. It is not a diagnosis or for monitoring of patients diagnosed with heart failure. This software is for use on adults (18 years and older).

Eko Low Ejection Fraction Tool (ELEFT) is an algorithm that is intended to aid clinicians to identify individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds from patients at risk for heart failure. The software uses signal processing as well as machine learning algorithms, to analyze the electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) recording signals generated by FDA-cleared Eko Stethoscopes and saved as .WAV file recordings in the Eko Cloud. ELEFT is a machine learning based notification software which employs machine learning techniques to suggest the likelihood of LVEF

The Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. The device takes ECG and heart sound inputs and processes them using signal processing and machine learning algorithms.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a numerical target format (e.g., "Sensitivity must be >= X%"). However, the clinical performance results presented demonstrate the device's capability to detect Low EF. The acceptance effectively hinges on the presented sensitivity and specificity values.

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

• Test Set Sample Size: 3,456 unique subjects. After excluding 307 recordings due to poor ECG quality, the performance analysis was based on the remaining suitable recordings.
• Data Provenance: Retrospective data collected from:
  • US, 5 sites: 2,960 patients.
  • India, 1 site: 496 patients.

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

• Number of Experts: Not explicitly stated as a number, but the ground truth for ejection fraction was "overread by a board-certified cardiologist." This implies at least one, and potentially multiple, board-certified cardiologists were involved in reviewing the echocardiogram results.
• Qualifications of Experts: Board-certified cardiologists.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for resolving discrepancies in ground truth establishment. It states that the "subject's true ejection fraction was measured by the echocardiogram machine's integrated cardiac quantification software at the echocardiogram and then overread by a board-certified cardiologist." This suggests a single expert review after automated measurement, with no mention of multiple reviewers or a formal reconciliation process if initial measurements or interpretations differed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focuses solely on the standalone performance of the ELEFT algorithm without a human-in-the-loop component or evaluating the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was conducted. The results for sensitivity, specificity, PPV, and NPV presented in Table 2 and the subsequent text (page 9) are for the ELEFT algorithm's performance in differentiating between Low EF (≤40%) and Normal EF (>40%).

7. Type of Ground Truth Used

The type of ground truth used was expert consensus / pathology based on instrumental measurements and expert review:

• Echocardiogram (Instrumental Measurement): The true ejection fraction was measured by the echocardiogram machine's integrated cardiac quantification software.
• Expert Overread: This measurement was "overread by a board-certified cardiologist."
• Categorization: Ejection status (Low EF or Normal EF) was then assigned based on these measured and reviewed values.

8. Sample Size for the Training Set

The sample size for the training set was 1,852 patients. This data was contributed from:

• US, 7 sites: 1,515 patients.
• India, 1 site: 337 patients.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly detail the exact process for establishing ground truth for the training set. However, given the consistency in the data description and the validation methodology, it is highly probable that the ground truth for the training set was established using the same methodology as the test set: gold standard echocardiogram measurements, subsequently overread by board-certified cardiologists, and then categorized into Low EF (≤40%) or Normal EF (>40%).

Ask a specific question about this device

The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

CORE 500 Digital Stethoscope (CORE 500) is an electronic stethoscope with integrated electrodes for electrocardiogram (ECG). The device consists of a chestpiece, detachable earpiece (Eko Earpiece) and a mobile application (Eko App) and is intended as a digital auscultation tool on patients requiring physical assessment by the clinicians or lay users. CORE 500 provides the ability to amplify, filter, and transfer body sounds with the chestpiece diaphragm, and three lead ECG through electrodes integrated around the chestpiece. The device can be used in a professional healthcare facility and for home use.

CORE 500 features three auscultation modes for a better auscultation experience by filtering acoustic data and enhancing the primary frequency range of particular body sounds: Cardiac Mode for heart sounds, Pulmonary Mode for lung sounds, and Wide Band Mode for general auscultation. CORE 500 also detects and computes the heart rate in real time based on the phonocardiogram (PCG) data.

This FDA 510(k) summary for the Eko Health, Inc. CORE 500 Digital Stethoscope (K233609) describes the device's technical specifications and how it compares to a predicate device. Regarding acceptance criteria and detailed study results, the document provides a general overview rather than specific performance metrics.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values for the CORE 500 Digital Stethoscope in the way one might expect for a clinical performance study. Instead, it lists the types of nonclinical testing performed and asserts that the device complies with standards or demonstrates performance.

Here's a summary of the reported performance without specific numerical acceptance criteria from the document:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for test sets, data provenance, or whether studies were retrospective or prospective. The performance data section focuses on nonclinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The performance data is described as "nonclinical testing" and does not appear to involve expert-adjudicated ground truth as typically found in clinical studies assessing diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. As the document focuses on nonclinical performance, an adjudication method on a clinical test set is not 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, the CORE 500 Digital Stethoscope, is primarily an electronic stethoscope for amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying ECG and heart rate. It is not described as having an AI diagnostic interpretation component that would typically be evaluated in an MRMC study with human readers.

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

The document does not explicitly state that a standalone (algorithm only) performance study was done for any specific AI functionality. The device displays ECG waveforms and heart rate, but the document does not describe it as having an autonomous diagnostic algorithm for complex conditions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that the performance data described is "nonclinical testing" (bench testing, biocompatibility, electrical safety, software V&V, usability), the concept of "ground truth" as it applies to clinical diagnostic accuracy (e.g., expert consensus, pathology) is not applicable or described in this section. The testing would have focused on meeting technical specifications and regulatory standards.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of information would typically be provided for devices involving machine learning or AI algorithms with extensive training phases, which is not the primary focus of the performance data in this submission.

9. How the ground truth for the training set was established

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary of Device and Performance Context:

The K233609 submission for the CORE 500 Digital Stethoscope primarily focuses on demonstrating substantial equivalence to its predicate device (K230111) and a reference device (K200776), particularly for its expanded "Over-The-Counter Use" and inclusion of "lay users." The performance data provided are centered on foundational nonclinical tests to ensure safety, efficacy, and compliance with general device regulations and standards. It's not a submission for a novel diagnostic AI algorithm requiring extensive clinical performance studies with ground truth establishment by experts. The "nonclinical testing" confirms the device's technical functionality, biocompatibility, electrical safety, software validation, and usability for its intended purpose of amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying basic heart rate and ECG.

Ask a specific question about this device