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The eKuore Stethoscope Touch 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.

The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible 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 Stethoscope Touch is formed by eKuore Stethoscope Touch device, eKuore Medical Devices App and eKuore Touch Android Engine.

The eKuore Stethoscope Touch device introduces three different models:

• . ES001 is the basic version of the electronic stethoscope for general purposes.
• . ES002 is an electronic stethoscope designed for people with hearing problems and enable hearing aids connection.
• ES003 is an electronic stethoscope that can connect to third-party software ● using an Android Library.

The primary purpose of the eKuore Stethoscope Touch device is to detect and amplify heart, lung, arteries, veins, and internal sounds using selective frequency organ ranges.

The design of eKuore Stethoscope Touch lets the user change the chestpiece attached between different sizes depending on the patient to be auscultated.

The primary purpose of the eKuore Medical Devices App is to get the acoustic signals from the eKuore Stethoscope Touch device. Once the device is turned on, the smartphone/tablet could detect a Bluetooth device.

After the connection, the eKuore Medical Devices App displays the acoustic signal as a phonogram in real-time, on the monitor screen, there is a record button. When it is pressed, the recording start, a record maximum duration of 30 seconds is defined. To stop the record, the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet. Each recording is stored named with the date and time of the moment of the record.

eKuore Medical Devices App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Medical Devices App lets the user share the records.

eKuore Touch Android Engine enable third party companies to connect eKuore Stethoscope Touch model ES003 to obtain the audio from the device and use it in their own software. Audio is transmitted without modifications or processing.

The provided text describes a 510(k) premarket notification for the eKuore Stethoscope Touch. This submission seeks to demonstrate the device's substantial equivalence to a legally marketed predicate device (eKuore Pro Series, K203007).

The document details the device's purpose, characteristics, indications for use, and a comparison to the predicate device. However, it does not contain specific acceptance criteria or the details of a study proving the device meets those criteria, as typically seen with performance metrics like sensitivity, specificity, or F1-score for AI-driven devices.

Instead, the submission focuses on demonstrating equivalence in terms of intended use, technological characteristics, and compliance with general medical device standards. The "study" mentioned is a "Summary discussion of non-clinical data," which outlines various tests and standards met, rather than a clinical performance study with predefined acceptance criteria for diagnostic accuracy.

Therefore, many of the requested items cannot be extracted directly from the provided text.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of acceptance criteria and performance metrics for diagnostic accuracy. The document states "Device signal acquisition accuracy and acoustic transmission disturbance have been evaluated successfully, presenting in all devices with similar acoustic characteristics" as a general outcome of non-clinical testing. This indicates performance was compared to the predicate, implying similar performance is the "acceptance criterion" for these aspects, but no quantitative thresholds are given.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified (since it's a non-clinical "acoustic performance comparison" rather than a clinical study with patient data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study mentioned is an "acoustic performance comparison" and non-clinical testing, not a diagnostic accuracy study requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable. No expert-driven ground truth establishment or adjudication process is described for this non-clinical comparison.

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

No, an MRMC comparative effectiveness study was not done. The eKuore Stethoscope Touch is an electronic stethoscope that facilitates sound recording and transfer, but it is not explicitly stated to be an AI-assisted diagnostic device that would involve "human readers improve with AI vs without AI assistance." Its indication is for "diagnostic decision support," but this appears to be through improved sound quality and digital record-keeping rather than an AI interpretation. The document explicitly focuses on demonstrating substantial equivalence to a predicate electronic stethoscope through non-clinical performance and safety data.

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

Not applicable. As noted above, the device is an electronic stethoscope producing amplified and filtered sounds, and it's not described as having a standalone diagnostic algorithm for interpretation without human intervention. The "eKuore Medical Devices App" displays the acoustic signal (phonogram), allows recording, and basic editing/sharing, but not AI-driven interpretation.

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

Not applicable. The "acoustic performance comparison" for the non-clinical data would likely compare the device's output to a known, calibrated acoustic standard or the output of the predicate device, not a diagnostic ground truth like pathology for AI performance evaluation.

8. The sample size for the training set

Not applicable. The document does not describe the development of an AI algorithm or a training set for machine learning.

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

Not applicable. No AI algorithm or training set is described.

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The eKuore Pro 4T 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 Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.

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 Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.

• . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
• eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.

The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.

The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.

eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:

• Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
• Get and set additional information about the connected device: ●
  • o The battery level of the device
  • The firmware version of the device o
  • The serial number of the device o
  • The volume level of the device o
  • The filter currently being used in the auscultation O
  • The hardware version of the device o
• Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.

The eKuore Pro 4T is an electronic stethoscope intended for use by healthcare professionals for diagnostic decision support in clinical settings. It electronically filters and transfers sounds to compatible software, allowing for the recording of heart sounds, cardiac murmurs, bruits, respiratory sounds, and abdominal sounds in pediatric and adult patients.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a table comparing them directly to device performance for the eKuore Pro 4T itself. Instead, it relies on demonstrating substantial equivalence to a predicate device (eKuore Pro Series, K203007) through a comparison of technological characteristics and compliance with various medical device standards.

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

The document 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." However, it does not specify any sample size for a test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for any specific performance study related to the eKuore Pro 4T's diagnostic capabilities.

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through technical comparisons and compliance with standards rather than a clinical performance study with human experts establishing ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No MRMC study is mentioned. The eKuore Pro 4T is described as a device that "electronically filter and transfer sounds to compatible software" and "can be used to record heart sounds...for diagnostic decision support." It is not presented as an AI-powered diagnostic tool, but rather as an electronic stethoscope that facilitates data transfer. Therefore, a comparative effectiveness study showing human reader improvement with AI assistance is not applicable in this context and not described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study is described. The device itself is an electronic stethoscope that captures and transmits sounds. The "eKuore Pro 4T Engine Java" is a library for third-party applications to communicate with the device, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The document does not describe any specific performance study that would require a defined ground truth (e.g., expert consensus, pathology, outcomes data) for diagnostic accuracy. The testing mentioned (non-clinical data, compliance with standards) relates to safety, electrical performance, software development, usability, and risk management rather than diagnostic accuracy against a clinical ground truth.

8. The Sample Size for the Training Set

This information is not provided because there is no mention of a machine learning or AI algorithm being trained by the device itself or an associated diagnostic software.

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

This information is not provided, as no training set for an AI algorithm is mentioned.

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The eKuore Pro Series 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 Pro Series 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 Pro Series is formed by eKuore Pro Series device and eKuore Pro App.

The eKuore Pro Series device introduce three different models:

• . eKuore Pro, the basic version of the stethoscope.
• eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems

The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App.

The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.

The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification.

After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. To stop the record the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet, each recording is stored named with the date and time of the moment of the record.

eKuore Pro App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Pro App lets the user share the records.

Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.

The provided text describes the eKuore Pro Series device, an electronic stethoscope, and its substantial equivalence to a predicate device (3M Littmann Electronic Stethoscope Model 3200, K083903) for FDA clearance. The document lists the general acceptance criteria of regulatory compliance and some performance characteristics but does not contain specific numerical acceptance criteria or detailed study results for the eKuore Pro Series device's performance.

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values for the eKuore Pro Series, nor can I provide details on sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth for the eKuore Pro Series itself, as this information is not present.

However, based on the information available, here's what can be inferred and stated:

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

The document primarily focuses on demonstrating substantial equivalence to the predicate device. The acceptance criteria described are mainly regulatory and general performance comparisons rather than specific quantitative thresholds.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified in the provided text. The document mentions "An acoustic performance comparison between eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed" but does not detail the sample size (e.g., number of recordings, number of patients).
• Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document does not describe the use of experts for establishing ground truth in the context of the acoustic performance comparison.

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

• Not specified.

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:

• No MRMC study is described. The device is an electronic stethoscope that filters and transfers sounds, not an AI-assisted diagnostic tool in the sense of offering interpretations or classifications that would involve human reader improvement with AI assistance.

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

• The device functions as an electronic stethoscope, amplifying and transferring sounds. Its primary performance claim is related to acoustic characteristics and signal acquisition, which would likely be evaluated in a "standalone" fashion (device output compared to a reference signal or predicate device output). The statement "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics" suggests a standalone evaluation, but specific metrics and methodology are not provided.

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

• For the acoustic performance comparison, the "ground truth" would likely be a reference acoustic signal or the performance of the predicate device. However, the exact nature of this "ground truth" (e.g., gold standard recordings, simulated sounds with known characteristics) is not specified.

8. The sample size for the training set:

• Not applicable/Not specified. The document does not describe machine learning or AI components that would require a "training set" in the conventional sense for image or signal classification. The device appears to be a signal processing and transmission tool.

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

• Not applicable/Not specified as there is no apparent training set mentioned.

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