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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 Eko Murmur Analysis Software (EMAS) is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.

The Eko Murmur Analysis Software is not intended as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. The Eko Murmur Analysis Software is intended for use on pediatric and adult patients.

Eko Murmur Analysis Software (EMAS) is a cloud-based service that allows users to upload heart sound/phonocardiogram (PCG) and optional electrocardiogram (ECG) data via an application programming interface (API) for analysis. The software uses signal processing (such as waveform filtering), as well as algorithms derived from machine learning, to analyze the acquired data and generate clinical decision support output for clinicians. EMAS is designed to evaluate data derived by the company's two previously cleared devices, the Eko DUO (K170874) and Eko CORE (K151319, K200776). The heart sound data from those devices can be transmitted to the Eko Cloud using either the Eko mobile application or thirdparty applications that use a software development kit (SDK). The EMAS algorithm analyzes the heart sound data and outputs a JSON file with the algorithm results, which is passed down to the requesting application and displayed by the requesting application to the user in the humanreadable format.

The analysis will assess the signal quality of the phonocardiogram; detect heart murmurs and classify them as innocent or structural; determine the timing of S1 and S2 heart sounds; and distinguish between systolic and diastolic heart murmurs. As an integral part of a physical assessment, clinicians' interpretations of EMAS' output can help them rule in or out different pathological conditions in a patient.

The EMAS consists of the following algorithm components:

• Signal Quality Detection Algorithm:
  This pre-processing algorithm accepts as input the PCG sound from the API controller (e.g., a mobile smartphone application). The algorithm is used to classify PCG recordings based on their signal quality as good or poor.

• Heart Sound Timing Algorithm:
  This algorithm detects the presence and timing of specific heart sounds including S1, S2, the systole region, and the diastole region.

• Murmur Detection & Classification Algorithm: This algorithm is used to identify and classify heart sounds as having "No Murmur", an "Innocent Murmur" (i.e., not pathologic), or a "Structural Murmur" (i.e., pathologic).

• Murmur Timing Algorithm:

This algorithm is used to identify in which regions of the heart cycle (systole vs diastole) a heart murmur occurs if either an "Innocent Murmur" or "Structural Murmur" is identified by the Murmur Detection and Classification Algorithm.

Here's an analysis of the Eko Murmur Analysis Software (EMAS) acceptance criteria and the study proving its performance, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Size: The document does not explicitly state a separate "test set" size. However, it indicates that the clinical validation used a database of 2,380 unique heart sound recordings from 615 unique subjects.
  • Of these, "recordings identified as being good signal by the expert cardiologists" (meaning suitable for analysis) included:
    • 45.8% (approx. 1090 recordings) with a confirmed structural murmur.
    • 54.2% (approx. 1290 recordings) with confirmed no murmur or innocent murmur.
  • For heart sound timing, 299 heart sound recordings were annotated.
• Data Provenance: Retrospective analysis on a proprietary database. The country of origin is not specified, but the applicant (Eko Devices, Inc.) is based in Oakland, California, USA.

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

• Number of Experts: "Multiple cardiologists" were used. The exact number is not specified.
• Qualifications of Experts: "Cardiologists." No further details on their years of experience or specific subspecialties are provided.

4. Adjudication Method for the Test Set

• Recordings were "annotated by multiple cardiologists."
• There's no explicit mention of an adjudication method like 2+1 or 3+1. However, the ground truth for murmur classification was obtained via "pairing cardiologist annotations with gold standard echocardiogram," suggesting that the echocardiogram served as the definitive ground truth reference alongside expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focuses on the standalone performance of the EMAS algorithm against a ground truth. There is no information provided about human readers improving with or without AI assistance.

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

• Yes, a standalone study was done. The reported performance metrics (Sensitivity, Specificity, PPV) are directly attributed to the "EMAS algorithm testing" and represent the algorithm's performance against the established ground truth. The device is intended as "decision support" and "not intended as a sole means of diagnosis," indicating it operates standalone and then informs a clinician.

7. The Type of Ground Truth Used

• For Murmur Classification: Ground truth was established by pairing cardiologist annotations with gold standard echocardiogram.
• For S1/S2 Timing: Ground truth was established via expert cardiologist annotations.

8. The Sample Size for the Training Set

• The document explicitly states: "No study subjects included in the training datasets were included in the test database." However, it does not provide the sample size for the training set. It only mentions that the algorithms were validated using "retrospective analysis on a proprietary database."

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

• The document does not explicitly describe how the ground truth for the training set was established. It only refers to a "proprietary database" used for training and then tested on a separate, distinct set of subjects. Assuming a consistent approach, it's likely similar methods (expert annotations, potentially with echocardiogram correlation) were used, but this is not stated.

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The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

The Eko CORE (OTC) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It enables physicians transition between traditional and digital auscultation. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians.

lt consists of two primary components: 1) The CORE: an electronic attachment for an analog stethoscope and 2) Eko App, and application that pairs with the CORE attachment.

• . CORE is used to record audio in the stethoscope, convert it to digital data points, and transmit data to a mobile device via Bluetooth". It includes a volume adjustment button, an analog-to-digital power switch, and an LED light indicator.
• . The app captures audio data from the CORE and provides data visualization, secure data storage, audio playback, and sharing features.

These features enable a healthcare professional to monitor patients, seek out second opinions from a specialist or use the device for telemedicine use.

The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins). It is intended for use on pediatric and adult patients by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative format for specific performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluation focuses on demonstrating that the Eko CORE is substantially equivalent to its predicate devices by showing it functions as intended and adheres to safety standards.

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

The document mentions "human factors testing," which is a type of test set, but does not specify the sample size used for this testing. It also does not directly state the country of origin or whether the data was retrospective or prospective for any of the performance tests. The context suggests that the testing was conducted by Eko Devices, Inc. likely in the US where it's seeking FDA clearance.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For human factors testing, the "ground truth" would typically relate to the usability and comprehension of the device by representative users. For the functional and safety testing, the "ground truth" is adherence to technical specifications and regulatory standards.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method like 2+1 or 3+1. The performance data section refers to "bench verification," "software verification and validation," "electrical safety, EMC and wireless coexistence testing," and "human factors testing." These types of tests typically involve objective measurements against predefined standards rather than expert adjudication of qualitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The Eko CORE is an electronic stethoscope intended for amplification, filtering, and transmission of sounds, not an AI-powered diagnostic tool in the sense of automatically interpreting sounds or assisting human readers with an AI model. Therefore, this type of study is not relevant to the described device.

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

The Eko CORE is a hardware device (an electronic stethoscope attachment) that works with an app. Its primary functions are amplification, filtering, and transmission of sound data. It's not described as having an "algorithm only" component that would perform diagnostic interpretations independently. The "performance data" described (bench, software, electrical, EMC, wireless, human factors) are for the device's functional integrity and safety, not for a standalone diagnostic algorithm. Therefore, a standalone performance study in the context of an "algorithm only" is not applicable or described.

7. The Type of Ground Truth Used:

The "ground truth" for the performance claims appears to be based on:

• Technical Specifications and Regulatory Standards: For bench verification, software V&V, electrical safety (IEC 60601-1), and EMC safety (IEC 60601-1-2).
• User Performance and Comprehension: For human factors testing related to OTC use, assessing if the device can be used safely and effectively by lay users.

8. The Sample Size for the Training Set:

The document does not mention any training set. This device is an electronic stethoscope, not an AI/ML diagnostic algorithm that would typically require a training set of data for model development. The performance testing described focuses on the device's functional and safety characteristics.

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

Since there is no mention of a training set or an AI/ML algorithm requiring one, this information is not applicable or provided in the document.

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The Eko Analysis Software is intended to provide support to the evaluation of patients ' heart sounds and ECG's. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias.

It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).

The Eko Analysis Software is a cloud-based software API that allows a user to upload synchronized ECG and heart sound/phonocardiogram (PCG) data for analysis. The software uses several methods to interpret the acquired signals including signal processing and artificial neural networks. The API can be electronically interfaced, and perform analysis with data transferred from multiple mobile or computer based applications.

The EAS software is only intended to be used in conjunction with data acquired using two previously-cleared physiological data acquisition devices (Eko DUO (K170874) and Eko CORE (K151319)). The software is designed to be used with companion mobile apps that are used during data acquisition. After analysis, results are returned through an interface to the mobile apps for display.

The algorithm consists of the following components:

• Rhythm detection algorithm: A neural network model that uses ECG to detect normal sinus rhythm and atrial fibrillation.
• Murmur detection algorithm: A neural network model that uses heart sounds to detect the presence of murmurs.
• Heart rate analysis algorithm: A signal processing algorithm that uses ECG or heart sounds as appropriate to calculate heart rate. It also provides an alert if the measured heart rate is indicative of Bradycardia or Tachycardia.
• QRS duration algorithm: A signal processing algorithm that measures the width of the QRS pulse on a single-channel ECG.
• EMAT Interval algorithm: A signal processing algorithm that uses Q peak detection and S1 envelope detection to measure the Q-S1 interval, defined as electromechanical activation time or EMAT.

Here's an analysis of the acceptance criteria and study details for the Eko Analysis Software, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or error rates that the device had to meet for clearance. However, it presents the performance results of the device's algorithms, implying that these results were considered acceptable for demonstrating substantial equivalence.

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

• Rhythm Detection Test Set:

  • Proprietary EKO ECG dataset: 732 ECG recordings from 139 patients.
    • Provenance: Retrospective. Collected using Eko DUO (732 recordings from 139 patients) and Eko CORE (1445 recordings from 236 patients) devices. Geographic origin not explicitly stated, but proprietary datasets from "individual volunteers" suggest it could be a local or multi-center collection by Eko Devices Inc.
  • Publicly available databases: MIT-BIH Arrhythmia Database, MIT-BIH Arrhythmia Noise Stress Database, AHA Database, NST Database, Physionet QT Database, PhysioNet 2016 Database.
    • Provenance: Retrospective. International, well-established public reference datasets.

• Murmur Detection Test Set:

  • Eko Heart Sound Database: Data collected using both Eko CORE and Eko DUO devices.
    • Provenance: Retrospective. Similar to the EKO ECG dataset, proprietary data collected from "individual volunteers." The combined total number of patients/recordings from both devices is 139 + 236 = 375 patients and 732 + 1445 = 2177 recordings for the proprietary dataset. It's unclear if the "Eko Heart Sound Database" is precisely the same as the "EKO ECG dataset" or a subset/superset, but the description points to the same underlying proprietary data collection.

• Heart Rate Calculation Test Set:

  • Publicly available datasets: Same as Rhythm Detection (MIT-BIH, etc.).
  • Proprietary EKO ECG dataset: Same as Rhythm Detection (732 ECG recordings from 139 patients).

• QRS Duration Calculation Test Set:

  • Publicly available PhysioNet QT database.

• EMAT Calculation Test Set:

  • Publicly available Physionet 2016 database.
  • Proprietary Eko ECG dataset: Same as Rhythm Detection (732 ECG recordings from 139 patients).

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test sets.

• For publicly available datasets (like MIT-BIH, PhysioNet), the ground truth is typically established by multiple cardiologists or electrophysiologists based on extensive review and annotation, often with published consensus guidelines. The qualifications of these annotators are generally high, representing expert cardiac clinicians/researchers.
• For the proprietary Eko datasets, the document does not specify how the ground truth was established, who established it, or their qualifications. It mentions "retrospective analysis," which usually implies that an expert (or panel of experts) reviewed the recordings and clinical data to determine the presence of conditions (e.g., AFib, murmur) for ground truth labeling.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth for any of the test sets, either for public or proprietary data. For public databases, consensus annotations are the typical method. For proprietary data, this information is not provided.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is present in the document. The study focuses purely on the standalone performance of the algorithms.

6. Standalone (Algorithm Only) Performance Study

Yes, the document exclusively describes standalone performance studies. It reports the performance metrics (sensitivity, specificity, error rates) of the Eko Analysis Software's algorithms directly on the test datasets, independent of human interaction or a human-in-the-loop workflow.

7. Type of Ground Truth Used

The ground truth used appears to be expert consensus or expert-annotated data.

• For publicly available databases, ground truth is typically derived from expert annotations and established clinical criteria.
• For proprietary datasets, the nature of the metrics (e.g., sensitivity/specificity for rhythm and murmur detection) strongly implies that a human expert (or panel) reviewed the ECG and heart sound recordings to classify them as having or not having AFib, normal sinus rhythm, or a murmur, which served as the reference standard.

8. Sample Size for the Training Set

The document does not provide a specific sample size for the training set. It mentions that the algorithms use "artificial neural networks" and that testing was carried out using "retrospective analysis on a combination of publicly available (...) and proprietary datasets." While these datasets were used for validation, the size and composition of the training datasets are not described.

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

The document does not describe how the ground truth for the training set was established. Given that neural networks were used, the training data would also have required labeled ground truth. It is reasonable to infer that if external/public datasets were used for validation, they likely also formed part of or informed the training process, and proprietary data collected by Eko would also have been used for training, with ground truth established similarly to the validation data (i.e., expert review/consensus, though not explicitly stated for training).

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The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). 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 device can be used on adults and pediatrics.

The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

The device should not be used on infants weighing less than 10kg.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Eko Model E5 System. It primarily outlines the regulatory approval of the device and its intended use. It does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or details about the study design (sample size, expert involvement, ground truth establishment, MRMC study, etc.).

Therefore, I cannot extract the requested information to describe the acceptance criteria and the study that proves the device meets them from the provided text.

To answer your request, I would need a different document, such as a summary of the clinical or performance testing conducted for the Eko Model E5 System, which would typically be included in the full 510(k) submission or a dedicated study report.

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The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

The Eko Electronic Stethoscope System is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

This document is a 510(k) clearance letter for the Eko Electronic Stethoscope System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the letter and the "Indications for Use" statement do not contain information about acceptance criteria or a study proving that the device meets such criteria.

The provided text describes the device's intended use and FDA regulatory information but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Whether a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore,Based on the provided document, I cannot answer your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and an "Indications for Use" statement, neither of which includes the detailed performance study information you've requested.

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