(129 days)
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.
| Acceptance Criterion Type | Description of Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials in contact with the body must be biocompatible. | Complies with ISO 10993-1:2018. The evaluation report concluded that the device is biocompatible. |
| Electrical Safety | Device must meet electrical safety standards. | Complies with IEC 60601-1. |
| EMC (Electromagnetic Compatibility) | Device must meet electromagnetic compatibility standards. | Complies with IEC 60601-1-2. |
| Software Verification & Validation | Software must be verified and validated. | Verified and validated according to FDA guidance. |
| Bench Testing (General Performance) | Differences between the subject and predicate devices do not raise new questions of safety and effectiveness. | Rigorous bench testing conducted to demonstrate product performance. |
| Audio Performance | Acoustic performance (amplification, filtering) must be adequate for intended use. | Testing conducted to verify audio performance. (Specific metrics not detailed in summary) |
| Electrical & Mechanical Function | Electrical and mechanical functions (e.g., buttons, display, connectivity) must operate as intended. | Testing conducted to verify electrical and mechanical function. (Specific metrics not detailed in summary) |
| Heart Rate Measurement | Heart rate detection must be accurate based on PCG data. | Testing conducted to verify heart rate measurement. (Specific metrics not detailed in summary) |
| ECG Frequency Range | While different from predicate (0.1-250 Hz vs 0.15-200 Hz), the wider range should not raise new safety/effectiveness questions. | Deemed acceptable as it "does not raise different questions of safety and effectiveness." |
| Number of ECG Electrodes | While different from predicate (3 dry electrodes vs 2 dry electrodes), the change should not raise new safety/effectiveness questions. | Deemed acceptable as it "does not raise different questions of safety and effectiveness." |
| Hardware Interface | While different from predicate (additional display, capacitive touch), the added features should not raise new safety/effectiveness questions. | Deemed acceptable as the "additional interfaces do not raise different questions of safety and effectiveness." |
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.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.