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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.

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The CORE 500 Digital Stethoscope is intended to be used by clinicians 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).

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

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 health care providers. 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.

CORE 500 features three auscultation modes for 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.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Eko CORE 500 Digital Stethoscope:

Note: The provided document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not detail a clinical study with specific acceptance criteria related to diagnostic performance involving human subjects and ground truth established by experts. The "acceptance criteria" discussed below are based on the non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an electronic stethoscope, the "acceptance criteria" are derived from the performance data provided to show equivalence and functionality. The document doesn't explicitly list pass/fail criteria with numerical thresholds in the same way a clinical trial might, but it states that "the CORE 500 Digital Stethoscope complies with" or "demonstrated compliance" with various standards and performance benchmarks.

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

The provided document describes non-clinical bench testing rather than a clinical study with a "test set" of patient data. Therefore, there is no patient sample size or provenance information in the sense of a clinical trial (e.g., country of origin, retrospective/prospective). The testing involved physical devices and simulated or controlled environments to assess performance properties.

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

As this was non-clinical bench testing, no medical experts were explicitly used to establish "ground truth" for a patient test set. The tests focused on objective electrical, mechanical, and software performance criteria verified against technical standards and internal specifications, not diagnostic accuracy in a clinical context.

4. Adjudication Method for the Test Set

Since there was no patient test set requiring expert interpretation or diagnosis, there was no adjudication method (like 2+1 or 3+1) used.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance data for substantial equivalence, not a study assessing how human readers improve with or without AI assistance.

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

The document pertains to the CORE 500 Digital Stethoscope hardware, which amplifies, filters, and transfers body sounds and ECG waveforms, and displays ECG waveforms and heart rate. While the device processes signals, it's a diagnostic tool, and the indications for use explicitly state: "The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data." This indicates that the device is intended for human-in-the-loop use. Therefore, a standalone algorithm-only performance assessment in a diagnostic context was not the focus of this submission. The "heart rate detection" is a standalone function of the device, but its diagnostic interpretation is with a clinician.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1:2018 standards and laboratory testing results.
• Electrical Safety & EMC: Ground truth is established by compliance with IEC 60601-1 and IEC 60601-1-2 standards.
• Software V&V: Ground truth is established by meeting FDA Guidance for Premarket Submissions for Software and internal software requirements.
• Bench Testing (Audio, Electrical/Mechanical, Heart Rate): Ground truth is based on engineering specifications, established physical principles, and comparison to calibrated reference instruments/signals.

8. The Sample Size for the Training Set

The document describes premarket notification for a hardware device (digital stethoscope) with integrated capabilities. It does not mention machine learning or AI algorithms requiring a "training set" in the context of diagnostic interpretation (e.g., for automated murmur detection or arrhythmia classification). While heart rate detection is mentioned, the details of its underlying algorithm training are not provided. No specific "training set" size is part of this 510(k) summary.

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

Since no explicit "training set" for a diagnostic AI algorithm is described as part of this submission, the method for establishing its ground truth is not applicable here.

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