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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 One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless 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.

The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery.

The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application.

The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that.

The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.

The provided text is a 510(k) Premarket Notification for the "eKuore One Wireless Electronic Interface for Stethoscope" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy, sensitivity, specificity, or other clinical efficacy metrics. Instead, the document discusses technical characteristics and regulatory compliance to demonstrate equivalence to a previously cleared device.

Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document.

Here's what can be gathered, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical performance. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and regulatory compliance.

• Reported Device Performance: The document lists technical characteristics of the eKuore One Wireless electronic interface for stethoscope and compares them to a predicate device. This is not "performance" in the sense of diagnostic accuracy or clinical outcomes.

  Elements of Comparison (as per provided text)	eKuore One Wireless electronic interface for stethoscope (Candidate Device)	Eko electronic stethoscope system (Reference Device)	Comparison
  Regulatory data
  Regulatory Class	Class II	Class II	Identical
  Device Classification name	Electronic Stethoscope	Electronic Stethoscope	Identical
  Regulation Number	21 CFR 870.1875	21 CFR 870.1875	Identical
  Classification Product code	DQD	DQD	Identical
  FDA Clearance	Pending	K151319	-
  USE
  Intended use	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds.	Similar (Predicate also amplifies sound)
  Characteristics
  Principles of operation	Microphone & electronics for digitalization/codification, wireless (Bluetooth) to mobile.	Dispositive introduced in acoustic stethoscope, sound amplification, audio transmission to smartphone via Bluetooth.	Similar (Both acquire and transmit sound to a mobile app)
  Clinical conditions	Human body sounds related	Human body sounds related	Identical
  Use	Electronic stethoscope	Electronic stethoscope	Identical
  Compatibility	-Littmann 3M Cardiology III/IV -Littmann 3M classic II/III	-Littmann 3M Cardiology II/III -Welch Allyn Harvey Elite -ADC601 lines of analog stethoscopes	Similar (Both compatible with Littmann 3M Cardiology III)
  Prescription/OTC	Prescription use	Prescription use	Identical
  Intended for Direct Connection to Patient	No	No	Identical
  Use environment	Clinical	Clinical	Identical
  Type of users	Health-care personnel	Health-care personnel	Identical
  Target population	All types of patients	All types of patients	Identical
  Cleaning & Maintenance	Detach, alcohol wipe cleaning of eKuore One. Stethoscope cleaned between each patient.	Stethoscope and CORE cleaned between each patient. External parts with 70% isopropyl alcohol wipes.	Identical
  Technical equivalence
  Sound track transfer function	Yes	Yes	Identical
  Signal transmission for visualization	Bluetooth transmission to compatible smartphones/tablets	Bluetooth transmission to compatible smartphones/tablets	Identical
  Energy Source	Rechargeable Lithium Ion Battery	Rechargeable Lithium Ion Battery	Identical
  System required	Android and iOS	Android and iOS	Identical
  Hardware and software platforms	Mobile devices or tablets	Mobile devices or tablets	Identical
  Connections	Micro USB connector only to charge internal battery	Micro USB connector only to charge internal battery	Identical
  Frequency range	20 Hz to 2 KHz	20 Hz to 2 kHz	Identical
  Signal Input Method	Sound collected via a Transducer. MEMS	Sound waves collected via a Transducer. Electro microphone	Identical
  Audio Output Method	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Earbuds and 3.5mm Jack when connected with smartphone/tablets	Identical
  Signal Storage	Allows signal storage depending on technical features of connected device.	Allows signal storage depending on technical features of connected device.	Identical
  Performance requirements	Temp range: -20℃ to +45℃ Humidity range: 0% to 90%	The operating range is 10℃ to 40℃, and 0% to 90% relative humidity	Similar
  Biological Equivalence
  Materials	Cover: ABS and EPDM; Pushbutton: PMMA; Gasket: EPDM	Body: ABS (Acrylonitrile Butadiene Styrene).	Similar
  Contact with human tissues or body fluids	Does not contact patient's body. Attached stethoscope does.	Does not contact patient's body. Attached stethoscope does.	Identical
  Sterility	Sterility considerations are not applicable	Sterility considerations are not applicable	Identical

2. Sample size used for the test set and the data provenance: Not provided. The submission relies on non-clinical test data and comparison to a predicate device, not a clinical test set for diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This document does not describe an AI device or a comparative effectiveness study. The device is a "Wireless Electronic Interface for stethoscope" which electronically filters and transfers sounds.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an electronic interface for a stethoscope, meant to be used by healthcare professionals. It's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study requiring ground truth is described.

8. The sample size for the training set: Not applicable, as no machine learning algorithm requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

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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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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.

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.

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