(257 days)
The eKuore One electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
eKuore One is a system formed by eKuore One device and eKuore ONE App. The main purpose of eKuore One device is to digitalize auscultation sounds. The main purpose of eKuore ONE App is to get the acoustic signal from eKuore One device through point to point connection via USB OTG cable. The data transmission via the USB OTG cable provides high data integrity.
eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use.
eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected.
Once eKuore One device is detected, the application identifies the device and make a connection. Once connected, the application goes to the monitor screen where the phonogram is shown in real time, the data represented in the eKuore ONE App is not processes prior to display.
In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in .wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings.
eKuore ONE App has a recording management screen where it is possible to play, remove and edit a recording. The edition is only for the "PatientID" and "Position". The audio data of one recording can't be modified either shared.
eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration.
Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.
Below is an analysis of the provided FDA 510(k) summary for the eKuore One electronic interface for a stethoscope, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K181882) is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state acceptance criteria in the form of quantitative performance thresholds for accuracy, sensitivity, or specificity of detecting specific heart/lung sounds. Instead, the "acceptance criteria" are implicitly met by demonstrating that the eKuore One has similar technical characteristics and performance to the predicate device, the Eko Electronic Stethoscope System (K151319), and that any differences do not raise new questions of safety or effectiveness.
| Aspect | Acceptance Criteria (Implicitly met by demonstrating substantial equivalence to predicate) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Intended Use | Match the predicate device's intended use. | "The eKuore One electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems." (Identical to predicate) |
| Technological Characteristics | Similar to the predicate device, with any differences not raising new questions of safety or effectiveness. | Similarities: Compatible Stethoscopes (3M Littmann Cardiology II/III), Digital signal processor, Closed system with mobile app, Same frequency range (20 Hz to 2 KHz), Signal storage, Hardware and software platform (mobile devices/tablets). |
| Differences: Principle of operation (eKuore One digitalizes without amplification, Eko amplifies), Signal transmission (eKuore One wired USB, Eko Bluetooth), Energy Source (eKuore One via smartphone USB, Eko Lithium Ion Battery), Connections (eKuore One USB for communication, Eko USB for charging). | ||
| Acoustic Performance | Acoustic performance comparable to the predicate device. | "An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting both devices with similar acoustic characteristics." |
| Safety and EMC | Compliance with relevant electrical safety and electromagnetic compatibility standards. | Successful completion of AAMI ANSI 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02 standards. |
| Software Life Cycle | Compliance with medical device software development standards. | Successful completion of IEC 62304:2015. |
| Usability | Compliance with usability engineering standards. | Successful completion of AAMI ANSI IEC 62366:2007. |
| Risk Management | Identification, evaluation, and control of potential hazards. | Compliance with ISO 14971:2007. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical study or a labeled dataset for AI evaluation. The non-clinical data primarily involve bench testing for acoustic performance and compliance with relevant standards.
- Sample Size for Acoustic Performance: Not explicitly stated as a number of sound recordings or patients. The text mentions "An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed." and "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully." This suggests a comparative bench test rather than a large clinical sample.
- Data Provenance: The studies mentioned are primarily bench tests and compliance testing, not clinical data from patients. Therefore, the concept of "country of origin" or "retrospective/prospective" doesn't directly apply in the same way it would for clinical trials. The manufacturer is Chip Ideas Electronics S.L. from Valencia, Spain.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The studies described are non-clinical, focusing on technical and acoustic performance against a predicate device and compliance with engineering standards, rather than diagnostic accuracy studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As the studies are primarily bench tests and engineering compliance, a formal adjudication method for a "test set" with expert consensus would generally not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device." There is no mention of human reader studies, AI assistance, or effect sizes related to human improvement with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone AI algorithm performance study was not done. The device itself is an electronic interface for a stethoscope that digitizes and transfers sound to a mobile app for healthcare professionals to use. The mobile app displays a phonogram in real-time and allows recording. It does not perform automated diagnostic interpretation or decision-making on its own without human intervention, which would typically be the focus of a standalone algorithm performance study. The device is for "diagnostic decision support in clinical settings", implying human involvement.
7. The Type of Ground Truth Used
For the acoustic performance comparison, the "ground truth" was implicitly the acoustic characteristics and signal acquisition accuracy of the predicate device, the Eko Electronic Stethoscope System. The eKuore One was deemed successful because it presented "similar acoustic characteristics." For the standard compliance tests (e.g., electrical safety, software, usability), the "ground truth" was the requirements and specifications defined by the respective international standards.
8. The Sample Size for the Training Set
This information is not applicable/not provided because the device, as described, is an electronic interface tool and does not appear to incorporate an AI algorithm that requires a "training set" in the conventional machine learning sense for diagnostic purposes. The software displays raw or filtered phonograms and allows recording, but doesn't mention an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as in point 8. No training set for an AI algorithm is mentioned.
§ 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.