(12 days)
The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
The Eko CORE (OTC) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It enables physicians transition between traditional and digital auscultation. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians.
lt consists of two primary components: 1) The CORE: an electronic attachment for an analog stethoscope and 2) Eko App, and application that pairs with the CORE attachment.
- . CORE is used to record audio in the stethoscope, convert it to digital data points, and transmit data to a mobile device via Bluetooth". It includes a volume adjustment button, an analog-to-digital power switch, and an LED light indicator.
- . The app captures audio data from the CORE and provides data visualization, secure data storage, audio playback, and sharing features.
These features enable a healthcare professional to monitor patients, seek out second opinions from a specialist or use the device for telemedicine use.
The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins). It is intended for use on pediatric and adult patients by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
Here's an analysis 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 document doesn't explicitly list "acceptance criteria" in a quantitative format for specific performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluation focuses on demonstrating that the Eko CORE is substantially equivalent to its predicate devices by showing it functions as intended and adheres to safety standards.
| Acceptance Criteria (Implied by Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Device functions as intended for its Indications for Use (amplification, filtering, transmission of auscultation sound data, use by professional and lay users). | Functional testing demonstrated the device functioned as intended in all instances. This includes the ability to attach to a standard analog stethoscope, featuring both digital and analog auscultation modes, connecting via Bluetooth to the Eko App for visualization, recording, and transfer of data, and including on/off power buttons and volume adjustment controls. |
| Device meets electrical safety standards. | Electrical safety testing was successfully conducted, complying with IEC 60601-1. |
| Device meets EMC (electromagnetic compatibility) safety standards. | EMC testing was successfully conducted, complying with IEC 60601-1-2. |
| Device meets wireless coexistence standards. | Wireless coexistence testing was successfully conducted. |
| Device is safe and effective for over-the-counter (OTC) use by lay users (as this is a new indication compared to the RX predicate). | Human factors testing for OTC use yielded passing results, indicating that lay users can safely and effectively operate the device. |
| Device maintains similar technological characteristics and performance to predicate devices (Eko Electronic Stethoscope System (K151319) and Tyto Stethoscope (K181612)). | The document states "The Eko CORE is a modified version of the previously-cleared predicate device and has very similar technological characteristics. Minor changes have been made, but the devices have the same overall operational and technological characteristics...Both devices have the same frequency range and have the same maximum sound level." Performance data demonstrated the Eko CORE is as safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "human factors testing," which is a type of test set, but does not specify the sample size used for this testing. It also does not directly state the country of origin or whether the data was retrospective or prospective for any of the performance tests. The context suggests that the testing was conducted by Eko Devices, Inc. likely in the US where it's seeking FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish ground truth. For human factors testing, the "ground truth" would typically relate to the usability and comprehension of the device by representative users. For the functional and safety testing, the "ground truth" is adherence to technical specifications and regulatory standards.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method like 2+1 or 3+1. The performance data section refers to "bench verification," "software verification and validation," "electrical safety, EMC and wireless coexistence testing," and "human factors testing." These types of tests typically involve objective measurements against predefined standards rather than expert adjudication of qualitative outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and 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 Eko CORE is an electronic stethoscope intended for amplification, filtering, and transmission of sounds, not an AI-powered diagnostic tool in the sense of automatically interpreting sounds or assisting human readers with an AI model. Therefore, this type of study is not relevant to the described device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The Eko CORE is a hardware device (an electronic stethoscope attachment) that works with an app. Its primary functions are amplification, filtering, and transmission of sound data. It's not described as having an "algorithm only" component that would perform diagnostic interpretations independently. The "performance data" described (bench, software, electrical, EMC, wireless, human factors) are for the device's functional integrity and safety, not for a standalone diagnostic algorithm. Therefore, a standalone performance study in the context of an "algorithm only" is not applicable or described.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims appears to be based on:
- Technical Specifications and Regulatory Standards: For bench verification, software V&V, electrical safety (IEC 60601-1), and EMC safety (IEC 60601-1-2).
- User Performance and Comprehension: For human factors testing related to OTC use, assessing if the device can be used safely and effectively by lay users.
8. The Sample Size for the Training Set:
The document does not mention any training set. This device is an electronic stethoscope, not an AI/ML diagnostic algorithm that would typically require a training set of data for model development. The performance testing described focuses on the device's functional and safety characteristics.
9. How the Ground Truth for the Training Set Was Established:
Since there is no mention of a training set or an AI/ML algorithm requiring one, this information is not applicable or provided in the document.
§ 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.