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The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.

This submission is for device "The AccurSound Electronic Stethoscope AS-101 ("AS-101")". This submission expands upon a previously 510(k)-cleared device(K221805) by introducing two new reusable sensors, whereas the original device only included disposable sensors..

The AccurSound Electronic Stethoscope AS-101 ("AS-101") in this submission is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.

The microphone-equipped sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.

The multi-channel design allows healthcare professionals to attach disposable sensors or reusable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.

The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope (AS101), which is a modification of a previously cleared device (K221805). The modification involves the introduction of two new reusable sensors, whereas the original device only included disposable sensors. Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding performance results for specific clinical metrics. Instead, it relies on non-clinical testing and the substantial equivalence to the predicate device. The performance tests mentioned are general and not detailed with specific quantitative acceptance criteria in this document.

However, based on the information provided, the following non-clinical tests were conducted to ensure safety and performance:

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

The document explicitly states: "This submission does NOT include animal or clinical performance testing." Therefore, there is no clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) to report for the primary evaluation of this device (the modified AS-101 with reusable sensors). The assessment relies on non-clinical bench testing and the substantial equivalence to the predicate device.

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

As there was no clinical study conducted for this submission (specifically for the modified device), there is no information on experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable as there was no clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document states: "This submission does NOT include animal or clinical performance testing."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is an electronic stethoscope intended for use by healthcare professionals for direct patient assessment, not an AI algorithm acting in a standalone capacity. The "diagnosis decision support" refers to the device aiding the human professional, not replacing them or offering an automated diagnosis.

7. Type of Ground Truth Used

For the non-clinical tests conducted, the "ground truth" would be established by the industry standards and regulatory requirements themselves (e.g., passing specific electrical safety thresholds, demonstrating biocompatibility as per ISO standards, software functioning as specified). There is no "ground truth" in the sense of clinical reference diagnoses (e.g., pathology, outcomes data, expert consensus) because no clinical performance testing was performed for this submission.

8. Sample Size for the Training Set

Not applicable. The AccurSound Electronic Stethoscope is a hardware device for sound amplification and filtering. It does not appear to incorporate machine learning or AI that would require a "training set" in the conventional sense of AI/ML algorithms. The software mentioned is for device control and processing, verified through standard software validation, not through learning from data.

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

Not applicable, as there is no training set mentioned or implied.

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The Keikku is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation data of the patient (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on a network can listen to the auscultation data of a patient on site or at a different location on the network. The Keikku is intended for use on pediatric and adult patients. The Keikku 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 Keikku (Rx) is a digital stethoscope device designed for use by health care professionals in clinical settings and by lay users in non-clinical environments under healthcare provider supervision. The Keikku electronically amplifies, filters and transfers body sounds through the accompanying mobile application and is used for storage, sharing and transmitting the data for telemedicine use. It also enables lay users, under supervision from a healthcare provider, to listen to their body sounds (lungs, heart, arteries, veins, gastrointestinal tract, etc.), record and share it with their physicians during telehealth sessions. The Keikku consists of two primary components: 1. The Keikku device is an electronic stethoscope. The Keikku device is used for recording audio, converting it to digital data, and transmitting the data to a mobile device via Bluetooth®. It includes volume adjustment via rotation, tap feature for starting and ending the recording, and an LED light indicator for indicating the status of the device. 2. The Keikku App. The app captures audio data from the Keikku device and provides data visualization and annotation, secure data storage, audio playback, and sharing features. These features enable a healthcare professional to monitor patients, seek second opinions from a specialist or use the device for telemedicine use.

The provided text describes the Keikku Electronic Stethoscope and its substantial equivalence determination to predicate devices. However, it does not contain specific acceptance criteria or a detailed study that proves the device meets such criteria in the format explicitly requested.

The document states that "The test passed and met the predefined acceptance criteria" for performance testing related to audio frequency and NSR response, but it does not specify what those acceptance criteria were or present the reported device performance in a table. It also refers to usability evaluation as having "passing results" without detailing the study or its criteria.

Therefore, I cannot fully complete the requested table and answer all questions due to the lack of explicit information in the provided text.

Based on the available information, here is what can be extracted and what is missing:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided text for any of the performance studies.
• Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not specified. The document repeatedly refers to "tests" and "evaluations" but does not mention expert involvement in establishing ground truth for any test sets beyond general usability studies.

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 comparative effectiveness study is mentioned. The device's primary function is as an electronic stethoscope for amplification, filtering, and transmission of auscultation data, not an AI-assisted diagnostic tool for human readers.

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

• This question is not directly applicable in the context of an electronic stethoscope as described. The device itself (Keikku Electronic Stethoscope) performs sound capture, amplification, and filtering. It is inherently a "standalone" device in its primary functionality. However, it works with an accompanying mobile application for data visualization, storage, and sharing, and facilitates human practitioners' listening. There's no separate "algorithm only" performance reported that would be distinct from the device's inherent operation.

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

• The document primarily describes engineering and validation testing (biocompatibility, cleaning/disinfection, electrical safety, EMC, software). For the "Performance Testing," it states the purpose was "to verify the Keikku's performance is similar to that of its predicate and reference devices, Eko Core and 3M Littmann electronic stethoscope, in terms of audio frequency and NSR response." This implies the "ground truth" for performance was defined by the established performance characteristics of the predicate and reference devices, rather than a clinical ground truth like pathology or expert consensus on clinical diagnoses.

8. The sample size for the training set

• Not applicable as the document does not describe any machine learning models that would require a "training set." The Keikku device provides amplification, filtering, and transmission, but it's not described as having an AI component that is "trained" in the typical sense.

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

• Not applicable (see point 8).

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The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users 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 or by lay users).

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

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 clinicians or lay users. 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. The device can be used in a professional healthcare facility and for home use.

CORE 500 features three auscultation modes for a 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.

This FDA 510(k) summary for the Eko Health, Inc. CORE 500 Digital Stethoscope (K233609) describes the device's technical specifications and how it compares to a predicate device. Regarding acceptance criteria and detailed study results, the document provides a general overview rather than specific performance metrics.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not provide a table of acceptance criteria with corresponding reported device performance values for the CORE 500 Digital Stethoscope in the way one might expect for a clinical performance study. Instead, it lists the types of nonclinical testing performed and asserts that the device complies with standards or demonstrates performance.

Here's a summary of the reported performance without specific numerical acceptance criteria from the document:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for test sets, data provenance, or whether studies were retrospective or prospective. The performance data section focuses on nonclinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The performance data is described as "nonclinical testing" and does not appear to involve expert-adjudicated ground truth as typically found in clinical studies assessing diagnostic accuracy.

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

This information is not provided. As the document focuses on nonclinical performance, an adjudication method on a clinical test set is not described.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, the CORE 500 Digital Stethoscope, is primarily an electronic stethoscope for amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying ECG and heart rate. It is not described as having an AI diagnostic interpretation component that would typically be evaluated in an MRMC study with human readers.

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

The document does not explicitly state that a standalone (algorithm only) performance study was done for any specific AI functionality. The device displays ECG waveforms and heart rate, but the document does not describe it as having an autonomous diagnostic algorithm for complex conditions.

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

Given that the performance data described is "nonclinical testing" (bench testing, biocompatibility, electrical safety, software V&V, usability), the concept of "ground truth" as it applies to clinical diagnostic accuracy (e.g., expert consensus, pathology) is not applicable or described in this section. The testing would have focused on meeting technical specifications and regulatory standards.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of information would typically be provided for devices involving machine learning or AI algorithms with extensive training phases, which is not the primary focus of the performance data in this submission.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary of Device and Performance Context:

The K233609 submission for the CORE 500 Digital Stethoscope primarily focuses on demonstrating substantial equivalence to its predicate device (K230111) and a reference device (K200776), particularly for its expanded "Over-The-Counter Use" and inclusion of "lay users." The performance data provided are centered on foundational nonclinical tests to ensure safety, efficacy, and compliance with general device regulations and standards. It's not a submission for a novel diagnostic AI algorithm requiring extensive clinical performance studies with ground truth establishment by experts. The "nonclinical testing" confirms the device's technical functionality, biocompatibility, electrical safety, software validation, and usability for its intended purpose of amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying basic heart rate and ECG.

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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).

Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.

Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.

Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.

Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.

Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.

The provided submission describes an Aneroid Sphygmomanometer. Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the "Accuracy" of the device is ± 3 mmHg, which is also the performance reported. For "Biocompatibility" and "Safety & Performance", compliance with the specified ISO standards is the stated performance.

Note: The submission describes an aneroid sphygmomanometer, which is a mechanical device. The concept of an "AI device" with human-in-the-loop performance or standalone performance, sample sizes for test/training sets, adjudication methods, and expert qualifications for ground truth establishment, are not applicable to this type of device. The provided text is a 510(k) summary for a traditional medical device, not an AI/ML-powered device.

Therefore, the following points are answered with "Not Applicable" (N/A) due to the nature of the device.

2. Sample size used for the test set and the data provenance
N/A - This device is a mechanical blood pressure monitor, not an AI/ML-powered device that uses a "test set" in the context of data. The performance testing refers to compliance with a standard (ISO 81060-1), which involves testing the device itself, not an algorithm's performance on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - See explanation above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See explanation above.

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
N/A - This is a mechanical device, not an AI-assisted one.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is a mechanical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
N/A - The ground truth for this device's accuracy would be established by direct comparison to a reference standard, as defined by ISO 81060-1, which likely involves a calibrated pressure standard.

8. The sample size for the training set
N/A - This is a mechanical device, not an AI/ML-powered device that requires a "training set."

9. How the ground truth for the training set was established
N/A - See explanation above.

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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.

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.

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The AS-101 is an electronic stethoscope intended for the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.

The AccurSound Electronic Stethoscope AS-101 ("AS-101") is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.

The microphone-equipped disposable sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.

The multi-channel design allows healthcare professionals to attach disposable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.

The associated accessories include:

• Disposable sensor(s)
• Patient cable(s)
• Earphone
• Power adapter with power cord

The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope AS-101. It describes the device, its intended use, and compares it to a predicate device (3M Littmann Electronic Stethoscope, Model 3200).

However, the document explicitly states that this submission "does NOT include animal or clinical performance testing" and focuses solely on non-clinical (bench) testing. This means the document does not contain information about studies involving human subjects to assess clinical performance or comparative effectiveness with human readers.

Therefore, I cannot provide information for several of your requested points, as they pertain to clinical studies, AI performance studies, or human expert consensus, which are not detailed in this 510(k) summary.

Here's what I can extract and address based on the provided text:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since no clinical study data is provided, the "acceptance criteria" discussed are for the device's engineering performance and safety, rather than clinical efficacy or diagnostic accuracy.

Regarding the other requested information:

• Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes (e.g., number of devices tested), but this is not detailed for each specific test in the summary.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or human expert review.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
• 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 device is an electronic stethoscope and is not an AI-assisted diagnostic tool in the typical sense that would involve interpretative reading and MRMC studies. The document explicitly states "This submission does NOT include animal or clinical performance testing."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electronic stethoscope intended for human use, not a standalone diagnostic algorithm.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized safety standards.
• The sample size for the training set: Not applicable. This document is for a medical device (electronic stethoscope), not an AI/machine learning algorithm that would have a "training set."
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and compliance with relevant safety and performance standards, rather than clinical performance studies or AI validation.

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The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

HeartBuds is an electronic stethoscope intended to auscultate heart and lung sounds. HeartBuds Stethoscope can be used on any patient undergoing a physical assessment. This stethoscope consists of a hand-held device with integral plastic sound diaphragm, that must be used together with a smartphone equipped with the HeartBuds application software. HeartBuds Stethoscope allows users to digitally record heart and lung internal auscultation and transmit the sound data to a medical professional in another location. The HeartBuds system includes two (2) main components: The HeartBuds Electronic Stethoscope and the HeartBuds mobile app.

The HeartBuds Electronic Stethoscope connects to mobile devices (Apple and Android) by means of an audio cable. The HeartBuds app with the integrated HeartBuds software provides users a platform to listen, display, and record sounds simultaneously using an external microphone. The users can share their recordings with their healthcare provider within the HeartBuds app for remote examination.

The provided text describes the HeartBuds Electronic Stethoscope, which is an electronic stethoscope enabling the transmission of auscultation sound data. It specifically states that "Clinical data was not required for this type of device" (page 11), indicating that no clinical study was conducted to prove the device meets acceptance criteria related to its diagnostic performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Tyto Stethoscope K181612) through verification and validation activities against recognized standards. These activities are designed to ensure the device's safety and effectiveness in its stated use, rather than clinical diagnostic accuracy.

Therefore, the following information cannot be extracted from the provided text as it pertains to clinical studies that were not performed:

• A table of acceptance criteria and the reported device performance regarding diagnostic accuracy.
• Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (as this device transmits sound data for a clinician to interpret, it's inherently human-in-the-loop).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
• The sample size for the training set (as no AI algorithm for diagnostic inference is mentioned).
• How the ground truth for the training set was established.

However, the document does provide information on performance testing related to safety and usability. These are not diagnostic performance metrics, but rather engineering and operational validations.

Here's a summary of the acceptance criteria and performance as described for the device's overall design verification and validation:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical diagnostic performance study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical diagnostic performance study was conducted.

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. The device transmits raw sound data; it does not include AI for diagnostic assistance. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's function is to transmit sound data for human interpretation; it does not perform standalone diagnostic analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the verification and validation listed (e.g., electrical safety, usability), the "ground truth" would be compliance with the respective standards and design requirements, as demonstrated by successful test results. For instance, for usability, the ground truth was that users could effectively operate the device in a simulated environment. For biocompatibility, the ground truth was meeting ISO 10993 requirements.

8. The sample size for the training set: Not applicable as there is no mention of a machine learning algorithm or AI model requiring a training set for diagnostic classification.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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The Medaica M1 Telehealth Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Medica M1 Telehealth Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

The Medaica M1 Telehealth Stethoscope is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables three types of stethoscope exams: Heart. Lungs and Audio (Audio is for clinician only). The operation process of the Medaica M1 Telehealth Stethoscope uses four (4) primary functional elements:

• (1) The Medaica M1 Telehealth Stethoscope.
• (2) A patient's web-connected computer on which the Medaica Web Client software is running.
• (3) The Medaica Server on which the Medaica server software is running.
• (4) A clinician's web-connected computer on which the Medaica Web Client software is running.
  The Medaica M1 Telehealth Stethoscope operates either in Patient Store and Forward mode or Live, online mode. Both modes are essentially similar and share the same fundamental steps: performing one or more exams using the Medaica M1 Telehealth Stethoscope, recording the data and sending to a clinician, review of the exams by the clinician, and the user receiving a summary from the clinician presenting his/her assessment and/or recommendations. While in the Patient Store and Forward mode, the Patient can send the recorded data to the clinician whenever convenient for him/her. A Live, online mode can only be executed when the clinician is available online at the same time as the patient.

The provided text does not contain detailed acceptance criteria and a study dedicated to proving the device meets those specific criteria in the way a clinical performance study for an AI-powered diagnostic device might.

However, based on the Performance Testing section, we can infer some general performance criteria and how they were met:

Here's an attempt to answer your questions based on the available information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic performance (e.g., patient cases for diagnostic accuracy). The performance testing refers to engineering and regulatory compliance tests. Therefore, there's no information on sample size or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document outlines performance testing for device functionality, safety, and regulatory compliance, not for diagnostic accuracy evaluated by experts against a ground truth.

4. Adjudication method for the test set
Not applicable, as no diagnostic test set with ground truth established by experts is described.

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. The Medaica M1 Telehealth Stethoscope is described as an electronic stethoscope for transmitting auscultation sounds. The document does not indicate that it incorporates AI for diagnostic assistance to human readers. Its primary function is data transmission and sound capture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a stethoscope used by either a lay user or a clinician, with sound data interpreted by a clinician. It's not an AI algorithm performing standalone diagnoses.

7. The type of ground truth used
For the "Stethoscope performance testing" mentioned, the ground truth would likely be established by objective physical measurements (e.g., using calibrated sound sources and measurement equipment) to verify sensitivity, signal-to-noise ratio, and frequency response against established engineering specifications for stethoscopes. For "Biocompatibility" and "Electrical safety & EMC," ground truth is adherence to the specified international standards.

8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set in the machine learning sense.

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

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The ibiomedi Electronic Stethoscope ES-2020 is used to detect sound from the heart, arteries, veins, breathing sounds from the anterior/lateral chest and throat sounds in the neck. The chest piece is designed for children who are over two years old, teenagers and adults. It can be applied to any body type and can only be used for the purpose of medical diagnosis in clinics or hospitals.

The ibiomedi Electronic Stethoscope ES-2020 detects sounds from the heart, arteries, veins, breathing sounds from the anterior/posterior/lateral chest and throat sounds in the neck of patients. The sounds are transmitted to the user's ears through accessories such as earphones.

User interface includes A: Power button, frequency response mode button, volume button B: Power indicator, wireless transmission indicator, frequency response mode indicator, volume indicator.

Turn on the ibiomedi Electronic Stethoscope ES-2020 and connect to the wireless device via Bluetooth to transmit and store sounds. When the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device have walls, human bodies and other barriers, the effective range of Bluetooth transmission will be affected. It is recommended to reduce the distance between the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device to improve Bluetooth connection.Power to the device is provided by two AAA 1.5V batteries.

The associated accessories include.

• Small chest piece: For children with diaphragm. .
• Large chest piece: For adult with diaphragm.
• Audio line: For connecting external speakers.
• . 1MORE Earphones: For medical personnel to connect the ibiomedi Electronic Stethoscope ES-2020.

The provided text describes the ibiomedi Electronic Stethoscope ES-2020 which is used to detect sounds from the heart, arteries, veins, breathing sounds, and throat sounds. The text focuses on establishing substantial equivalence to a predicate device, as required by a 510(k) submission.

Here's an analysis of the acceptance criteria and study information provided in the document:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for direct clinical efficacy or diagnostic accuracy. Instead, the performance data provided focuses on:

• Followed modified ISO 10993-10:2010 (Irritation and Skin Sensitization), ISO 10993-5:2009 (Cytotoxicity).
• Tests included Guinea Pig Maximization Test (GPMT), Skin irritation test in rabbits, and Cytotoxicity study. |
  | Electrical Safety & Electromagnetic Compatibility (EMC) | - Complies with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; EN 60601-1: 2006 + A1: 2013; AAMI/IEC 60601-1:2005 + AMD 1:2012; CAN/CSA-C22.2 No. 60601-1:14 (for safety).
• Complies with IEC 60601-1-2: 2014 / EN 60601-1-2: 2015 (for EMC). |
  | Software Verification & Validation | - Level of concern identified as "Minor" (unlikely to cause injury).
• Software passed tests and met requirements of relevant standards. |
  | Performance Testing (Sound Amplification) | - Tests determined that sound amplification was not affected by the use of earphones.
• Performance data presented by traditional stethoscope and the subject device are "similar." |
  | Usability Study | - Acceptance Criteria: At least 85% of participants with no experience in this type of product will be able to use it properly after reading Instruction Manual for around 30 minutes.
• Summary: The summative evaluation objective of usability was met. |

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

• Usability Study: The sample size was 15 doctors and 15 nurses.
• Data Provenance: Not explicitly stated, but given that the applicant is Sound Land Corp. in Taiwan, it is likely that the usability study participants were from Taiwan. The document does not specify if the study was retrospective or prospective.

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

The document does not describe an expert-based ground truth establishment for the "Performance Testing" or "Usability Study" beyond the participants in the usability study being "doctors and nurses."

For the "Performance Testing" which compared the device to a traditional stethoscope, it's mentioned that their performance data are "similar," implying an unquantified comparison, not a ground truth derived from expert adjudication of sound quality or diagnostic outcomes.

4. Adjudication method for the test set

There is no mention of an adjudication method for establishing a ground truth.

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

There is no information about an MRMC comparative effectiveness study in the provided text. The device is an electronic stethoscope, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with or without AI assistance. The "doctors and nurses" in the usability study were likely evaluating ease of use, not diagnostic improvement with AI.

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

This section is not applicable as the ibiomedi Electronic Stethoscope ES-2020 is a sound detection and amplification device, not an algorithm that performs standalone analysis or diagnosis without human interaction.

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

The document does not report the use of a formal ground truth (like expert consensus, pathology, or outcomes data) for evaluating the diagnostic accuracy or clinical effectiveness of the stethoscope. The tests focused on safety, EMC, software functionality, and usability, as well as a general comparison to traditional stethoscopes regarding sound amplification.

8. The sample size for the training set

No information about a training set is provided. This is consistent with the nature of the device, which is an electronic stethoscope rather than a machine learning or AI-based diagnostic system that would require a distinct training set.

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

Not applicable, as there is no mention of a training set or ground truth for such a set.

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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. This product can measure the blood pressure of people aged 3 years and above.

Aneroid sphygmomanometer Model QL-20, QL-201/ Aneroid sphygmomanometer with stethoscope, Model QL-50 are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include cuff, inflation bulb, instruction manual and carrying case. Model OL-50 also includes a stethoscope. It is conjunction with stethoscope when use.

The provided text describes a 510(k) premarket notification for an aneroid sphygmomanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or algorithm performance.

Therefore, the requested information (acceptance criteria for an AI/device algorithm, MRMC study, standalone performance, training/test set details, expert ground truth establishment, etc.) is largely not applicable to this specific document as it pertains to a traditional medical device (manual blood pressure cuff) and not an AI/ML-driven diagnostic or assistive device.

However, I can extract and present the performance criteria that are relevant to this device type based on the provided document:

Acceptance Criteria and Device Performance (for an Aneroid Sphygmomanometer)

Since this is a traditional medical device (aneroid sphygmomanometer) and not an AI/ML-driven device, the acceptance criteria and performance evaluation focus on its physical and functional accuracy for blood pressure measurement, as well as biocompatibility, rather than AI performance metrics like sensitivity, specificity, or AUC.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a patient sample size for testing the aneroid sphygmomanometer itself. The testing performed was "Non-clinical testing" conducted to verify compliance with standards like ISO 81060-1. This standard typically involves technical accuracy testing, often on a test bench or with simulated pressures, and potentially with a limited number of human subjects for specific validation aspects depending on the exact test protocol followed.
• The data provenance is not explicitly stated as it would be for a clinical study. The device is manufactured by Zhejiang LuDe Technology Development Co., Ltd. in China. The testing would have been conducted by the manufacturer or a designated testing facility to meet regulatory requirements.
• The testing was described as "Non-clinical testing," implying it was not a large-scale prospective clinical trial with a defined patient population.

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

• This is not applicable as the device is a manual blood pressure monitor. "Ground truth" for blood pressure measurement (the actual pressure) is established through standardized calibration and reference measurement methods, not through expert consensus on images or interpretations.

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

• Not applicable. Adjudication methods are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. For a physical measurement device like a sphygmomanometer, accuracy is determined by comparison to a calibrated reference standard.

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 study was not done. This type of study is specifically designed for AI-assisted diagnostic tools and involves human readers interpreting cases with and without AI assistance. This document is for a traditional, manual blood pressure monitor without AI capabilities.

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

• Not applicable. This device does not have a standalone algorithm in the sense of an AI interpreting medical data. Its "performance" refers to its physical accuracy in measuring blood pressure.

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

• The ground truth for the "Accuracy" criterion would be calibrated reference pressures, produced by a precisely controlled pressure source. This is standard for testing blood pressure measuring devices against the ISO 81060-1 standard.

8. The sample size for the training set:

• Not applicable. This device is a hardware product, not an AI/ML model that requires a training set.

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

• Not applicable. As above, no training set for an AI/ML model is involved.

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