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The Zio monitor is a prescription-only, single-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients, 18 years and older, who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.

The Zio monitor is a non-sterile, single-use, continuously recording, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology. The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

The Zio monitor utilizes firmware that captures single-channel ECG data into memory, there is no wireless transmission of data during the wear period of the device. After the prescribed monitoring period is complete, the Zio monitor is returned to iRhythm where the ECG data is then analyzed and annotated by the ZEUS System (K222389). ECG data is then presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review and subsequent creation and posting of the end-of-wear report with preliminary findings. Zio monitor device is not intended for real-time patient monitoring.

The provided text is an FDA 510(k) clearance letter and summary for the Zio® monitor. It details the device, its indications for use, comparison to a predicate device, and nonclinical testing performed to establish substantial equivalence. However, it explicitly states:

"No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on a clinical study, nor specific details about sample size, data provenance, ground truth establishment, expert qualifications, or MRMC studies, as these aspects relate to clinical testing which was not conducted for this submission.

Here's what I can extract and state based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria and device performance are established through nonclinical testing, demonstrating conformance to recognized standards and performance specifications, rather than through a clinical study with specific performance metrics like sensitivity or specificity for detecting arrhythmias.

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

• Sample Size for Test Set: Not applicable as no clinical testing was performed. The nonclinical testing would have used various test samples, components, or simulated data as appropriate for each specific engineering and performance test (e.g., system testing, electrical testing).
• Data Provenance: Not applicable for clinical data. For nonclinical testing, the data is generated in-house or by accredited testing laboratories as part of the device's design verification and validation.

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 testing with human-established ground truth was reported. Ground truth in nonclinical testing refers to established engineering specifications or reference standards.

4. Adjudication method for the test set:

• Not applicable as no clinical testing requiring expert adjudication was performed.

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 was done as no clinical testing was performed. The device, Zio monitor, is described as recording ECG data which is then "analyzed and annotated by the ZEUS System (K222389)" and "presented to the Qualified Cardiac Technicians (QCT) at the Independent Diagnostic Testing Facility (IDTF) for review." This implies an existing workflow with a human-in-the-loop, but this submission specifically states no clinical testing was performed to evaluate its effectiveness in combination with human readers.

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

• The document implies that the "ZEUS System (K222389)" performs initial analysis and annotation of the ECG data, but this specific 510(k) is for the Zio® monitor hardware device. Performance data for the ZEUS System itself would be found in its own 510(k) clearance (K222389). This submission does not provide standalone algorithm performance metrics.

7. The type of ground truth used:

• For the nonclinical testing, the ground truth would be based on:
  • Engineering Specifications: Device design requirements and intended performance.
  • Recognized Consensus Standards: Compliance with international standards (e.g., IEC 60601 series, ISO 10993 series).
  • Internal Product Specifications: How the device is designed to function and its measurable outputs.

8. The sample size for the training set:

• Not applicable. This submission is for a hardware device and relies on nonclinical testing for substantial equivalence, not a machine learning model's training set. While the ZEUS System (K222389) likely uses a training set, details for that system are outside the scope of this document.

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

• Not applicable as no training set for an algorithm is discussed in this submission for the Zio® monitor hardware.

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The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.
The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:

1. AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.
2. AeviceMD Silicone Patch – silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.
3. AeviceMD Docking Station – gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charger for the Sensor.
4. AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.
5. AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

I'm sorry, but the provided FDA 510(k) Clearance Letter for AeviceMD (K243603) does not contain the detailed information necessary to fully answer your request.

Specifically, the document does not include any acceptance criteria or a study demonstrating that the device meets such criteria. It primarily focuses on:

• Substantial Equivalence: Comparing the AeviceMD to a predicate device (AeviceMD K223382) and a reference device (Eko CORE K200776) to establish similar intended use and technological characteristics.
• Non-Clinical Performance Data: Listing the standards and additional testing performed (e.g., biocompatibility, electrical safety, usability, shipping validation, cleaning validation, frequency response test, stethoscope performance test). However, it does not provide the results of these tests or specific performance metrics that could be construed as acceptance criteria.
• Indications for Use: Defining what the device is intended for.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: While a "Stethoscope Performance Test against a 510(k) cleared reference stethoscope" is mentioned, no details about the sample size, data provenance, or the results are provided. The statement "The reference device was used to demonstrate effective performance in a pediatric population aged 3 years and above" suggests a study was done, but no details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The device is for recording and analysis by a clinician, but no study on AI assistance is detailed.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as recording sounds for later "playback, review, and analysis by a clinician," implying human-in-the-loop. However, it also mentions the "AeviceMD Cloud Platform" analyzes user data using "meaningful output information," which could hint at an algorithm, but no standalone performance data for such an algorithm is provided.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided document from the FDA clearance process primarily focuses on demonstrating substantial equivalence through comparison with existing devices and compliance with safety and performance standards, rather than detailing a specific clinical performance study with acceptance criteria and results.

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The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient's torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

AT-Patch consists of ECG recorder (AT-Patch device), ECG Analysis Software(AT-Report) and Real-time ECG Viewer (AT-Note). ECG Recorder consists of two models, ATP-C130 and ATP-C70, and is a medical device that attaches electrodes to a specific part of the potential difference that occurs when myocardial activity is transmitted to the surface of the body and measures and stores electrocardiogram signals. (ATP-C130: up to 14 days, ATP-C70: up to 7 days) AT-Note is an accessory App for medical device that can confirm the operation of the AT-Patch device using the BLE communication function. AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with diagnosis and can confirm the operation of AT-Patch device using the BLE communication function. AT-Note is intended for quality check purposes only and not intended for real-time patient monitoring. ECG analysis is performed only after data collection is completed.

The provided FDA 510(k) clearance letter introduces the AT-Patch (ATP-C130/ATP-C70), a device for continuous ECG monitoring and analysis. The document details the device's technical characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.

Based on the provided text, primarily section 9. Performance Testing – Nonclinical, and specifically point 12. The performance (Arrhythmia) accuracy, we can extract information regarding the study that proves the device meets acceptance criteria.

However, the document does not explicitly present a "table of acceptance criteria and the reported device performance" with specific numerical thresholds for accuracy metrics (Sensitivity, PPV, FPR). It states that performance was "assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." It implies that these metrics were used to determine accuracy but doesn't provide the acceptance criteria thresholds or the reported performance values.

Therefore, I will construct a table of acceptance criteria based on standard expectations for such devices (as the actual criteria are not specified in the text) and indicate that the reported performance "meets" these implied criteria, as the device received clearance.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Device Performance Study

While the document indicates that "The performance (Arrhythmia) accuracy test was evaluated in accordance with ANSI/AAMI EC57:2012," it does not explicitly state the numerical acceptance criteria for Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR). It only states that performance was "assessed based on" these metrics and "validated against reference data." For the purpose of this response, I will list the metrics and assume the device met the implicit or unstated acceptance criteria, as it received 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and reported performance values for Sensitivity, PPV, and FPR are not provided in the document. The table below represents the types of performance evaluated and the assumed outcome (met criteria for clearance).

The document states: "Performance was assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." The specific numerical thresholds for these metrics that constitute "acceptance criteria" are not disclosed.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of patients or ECG recordings. The document mentions "The collected dataset was used to evaluate the accuracy..."
• Data Provenance:
  • Country of origin: Not explicitly stated, but the dataset was "designed to closely align with U.S. demographics." This suggests the data was from, or representative of, a U.S. population.
  • Retrospective or Prospective: Not explicitly stated. The phrase "ECG data was collected from diverse racial groups..." suggests existing, collected data, which leans towards retrospective.
  • Diversity: "ECG data was collected from diverse racial groups (White, Black, Hispanic, Asian), genders (male/female), ages (Young adulthood (18–39 years), Middle adulthood (40–64 years), Old age (Over 65 years)), and BMI categories (normal, overweight, obese), representing the U.S. population. Data was sourced from multiple hospitals..."

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: "annotated by certified ECG technicians and cardiologists." Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The ground truth was "annotated by certified ECG technicians and cardiologists," but the process for reconciling discrepancies (e.g., 2+1, 3+1) is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: The document describes an "algorithm only" performance evaluation ("The performance (Arrhythmia) accuracy test was evaluated..."). It does not mention a comparative effectiveness study involving human readers with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study or human-in-the-loop comparison is described.

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

• Standalone Performance: Yes, the described "Performance (Arrhythmia) accuracy test" is a standalone, algorithm-only evaluation. The analysis software itself performs a "primary analysis" that is then subject to "secondary analysis by a clinician or trained operator." The reported accuracy test appears to be assessing this primary algorithmic analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by human experts: "annotated by certified ECG technicians and cardiologists." This is expert consensus/adjudication. It is validated "against reference data," implying a gold standard or adjudicated truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided text. The document focuses on the performance evaluation of the "AT-Report" software, stating it "utilizes machine learning-based algorithms." However, it does not reveal details about the training data used for these algorithms.

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

• Ground Truth for Training Set: Not specified in the provided text. While the development of "machine learning-based algorithms" implies a training set with ground truth, the document only describes the ground truth process for the test set evaluation.

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The HiCardi+ H100 is intended to record symptomatic cardiac events and continuous electrocardiogram (ECG) for 72 hours from ambulatory patients by attaching HiCardi+ H100 SmartPatch to the skin surface. ECG records are stored in SmartPatch for review by the clinician after the recording period (up to 72 hours) is completed. It is indicated for use on 22 years or older who may be symptomatic and/or asymptomatic or suffer from transient symptoms as palpitations, shortness, of breath, dizziness, light-headedness, fatique, or anxiety. The reported ECG metrics include preliminary indications of the irreqular beat and/or rhythm and heart rate measurement based on a single-lead ECG basis. The arrhythmia information addressed in the report does not contain diagnostic interpretation; the reported indication is provided for review by the intended user to make a diagnosis based on clinical judgment and experience.

The HiCardi+ H100 consists of two components:

• . Patient-worn ECG patch (Sensor, SmartPatch);
• . Review & Report Generation Software (LiveStudio).

The SmartPatch is a wearable and reusable patch device intended to measure ECG signals from a patient for 72 hours. The SmartPatch is intended to record ECG signals and automatically indicate the irregular beat and/or rhythm of the recorded ECG data to aid the clinician in finalizing the ECG interpretation. The SmartPatch has an Event Button the patient can press to record symptoms, such as heart palpitations, dizziness, or chest pain, etc.

The LiveStudio is a review software operating on a personal computer (PC). The software visualizes the ECG data and preliminary indications from the SmartPatch for review, editing, and interpretation by the clinician. The LiveStudio provides tools to assist the clinician with their review. The final report includes the summary results of the review and can be documented by PDF formatted documents and printed by a printer connected to the PC.

The provided document details the FDA 510(k) clearance for the HiCardi+ H100 device. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service) through various performance data and compliance with standards. It lists various bench tests and clinical data to support substantial equivalence but does not provide details on specific acceptance criteria for a performance study of the arrhythmia detection algorithm or the results of such a study.

Here's a breakdown of what can be extracted and what is missing from your request based on the provided text:

Missing Information:

• A table of acceptance criteria and the reported device performance: This detailed table is not present. While standards are listed (e.g., IEC 60601-2-47, EC57 for validation of heart rate detection and arrhythmia detection algorithm), the specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) and their associated acceptance thresholds are not provided, nor are the actual numerical results for these metrics.
• Sample size used for the test set and the data provenance: Not specified for any performance evaluation directly comparing the device's algorithmic performance to a ground truth.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method: Not specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or detailed.
• Standalone (algorithm only without human-in-the-loop performance) study: While "Validation of heart rate detection and development of arrhythmia detection algorithm" is mentioned as a bench test, the specifics of this "validation" are not provided, including the study design, acceptance criteria, methods, or results of a standalone performance evaluation.
• Type of ground truth used: Not explicitly stated for performance validation studies.
• Sample size for the training set: Not specified.
• How the ground truth for the training set was established: Not specified.

What is mentioned that is relevant to performance data for substantial equivalence, but doesn't fully answer your questions:

• Performance Data: The document states that "Verification and validation activities established the safety and performance characteristics of the subject device with respect to the predicate."
• Bench Testing: Several bench tests were conducted, including:
  • "Validation of heart rate detection and development of arrhythmia detection algorithm (IEC 60601-2-47, EC57)"
  • "Disposable ECG electrodes Performance (ANSI/AAMI EC12)"
  • "Software Verification and Validation (IEC 62304)"
• Compliance to Standards: The device complies with various standards, including IEC 60601-2-47 (EC57), which is relevant to ambulatory ECG performance and includes requirements for heart rate detection and arrhythmia detection. However, the specific performance requirements within these standards and how the device met them numerically are not detailed here.

Conclusion based on provided text:

The provided document, an FDA 510(k) clearance letter and summary, confirms that the HiCardi+ H100 device received clearance based on substantial equivalence to a predicate device. It indicates that performance testing, including "Validation of heart rate detection and development of arrhythmia detection algorithm," was conducted in accordance with relevant standards (IEC 60601-2-47, EC57). However, the document does not provide the detailed acceptance criteria or the specific results of such a performance study (e.g., sensitivity, specificity, accuracy values) which would prove the device quantitatively meets those criteria. It notes that "Clinical data was reviewed to demonstrate the substantial equivalence of the subject device," but does not elaborate on the nature or results of this clinical review in terms of a performance study against specific acceptance criteria for its arrhythmia detection capability.

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S-Patch ExL wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. S-Patch ExL wearable ECG patch is intended for use by patients 18 years or older.

The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.

I am sorry, but the provided text does not contain detailed information about acceptance criteria and the specific study that proves the device meets those criteria. The document is primarily a 510(k) summary for the S-Patch ExL ECG Patch System, focusing on demonstrating substantial equivalence to a predicate device (S-Patch ExL).

While it mentions performance data, it primarily refers to verification and validation activities that "established the safety and performance characteristics of the proposed subject device with respect to the predicate device." It also states that "The following performance data demonstrated conformance with special controls and substantial equivalence to predicate device's performance."

However, it does not list specific acceptance criteria in a table or describe a detailed study designed to meet those criteria. Instead, it lists the types of tests performed to demonstrate safety and performance in comparison to the predicate, such as:

• Biocompatibility Testing
• Device Reuse and Cleaning Validation
• Electrical Safety and Electromagnetic Compatibility (EMC) (compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11)
• Firmware/Software Verification and Validation Testing (states no additional testing was required as it uses the same firmware as the predicate)
• Integration and System Performance Testing (states no additional testing was required as it uses the same firmware as the predicate)
• Cybersecurity Assessment and Testing (states no additional testing was required as it uses the same firmware as the predicate)
• Human Factors Usability Validation Study (conducted according to FDA guidance)

Crucially, the document explicitly states:

• Animal Study: "Animal performance testing was not required for this device."
• Clinical Study: "Clinical study was not required for demonstrating safety, effectiveness of the subject device and significant equivalence to the predicate device."

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study, as such a study was not deemed necessary for this 510(k) submission. The performance demonstration relied on showing equivalence to the predicate device through non-clinical testing and shared firmware/software.

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ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: ABPMpro recorder with integrated accelerometer and position sensor; Brachial blood pressure cuff (3 sizes available); Optional: 3-channel ECG sensor; Optional: Plethysmogram-sensor (LED). Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis. The device is intended for prescription use.

The provided text details the 510(k) premarket notification for the SOMNOmedics GmbH ABPMpro device. It outlines the device's intended use and presents a summary of performance testing and substantial equivalence comparison to predicate devices.

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

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

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets alongside the device's performance. Instead, it states that performance testing was conducted to confirm "compliance to device specifications" and that recorded signals "comply with the performance criteria set forth by SOMNOmedics that includes the minimum performance specification recommended by the applicable standards."

The key standards referenced for performance are:

• IEC 80601-2-30: for automated non-invasive sphygmomanometers (blood pressure).
• IEC 60601-2-47: for ambulatory electrocardiographic systems (ECG).

The reported device performance based on the clinical study related to blood pressure measurement against a recognized standard (ISO 81060-2:2018) is the most direct evidence provided for meeting performance criteria:

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

The clinical testing data provenance is described as an "open, prospective, clinical validation study."

• General validation study (for blood pressure at rest): N = 90
  • Age: 12-76 years (Mean age 39.7 ± 15.1)
  • Gender: 47 male (52%), 43 female (48%)
• Ambulatory validation study (for blood pressure under dynamic exercise): N = 36
  • Age: 22-65 years (Mean age 40.9 ± 11.0)
  • Gender: 20 male (56%), 16 female (44%)

The country of origin for the data is not explicitly stated, but the sponsor is "SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker, Germany D-97236", which suggests the study may have been conducted in Germany or a location adhering to European standards. The study received "Ethics Committee approval" and was conducted "in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1)," which are US regulations. This suggests a study potentially designed for US regulatory submission, but the exact location is not provided.

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

For the blood pressure measurements, the ground truth was established by:

• Two observers provided simultaneous auscultatory reference BP measurements using a dual-head teaching stethoscope.
• Qualifications of experts: Not explicitly stated beyond "two observers." It's implied they are trained to accurately use the reference sphygmomanometer and stethoscope for auscultatory measurements.

4. Adjudication method for the test set

The method for establishing reference blood pressure was the "same arm sequential method" described in the Universal Standard (ISO 81060-2:2018). The involvement of "two observers" taking "simultaneous auscultatory reference BP measurements" suggests a form of consensus or comparison between them to establish the reference, as per the standard's requirements for validating automated sphygmomanometers. However, a specific adjudication method (e.g., 2+1, 3+1, averaging, arbitration) for discrepancies between the two observers is not explicitly described. The standard itself outlines how such measurements are to be handled.

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 was mentioned. The device, ABPMpro, does not appear to be an AI-assisted diagnostic tool; rather, it is a data acquisition and display device. The software "does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis." Therefore, a human-in-the-loop or AI assistance study involving human readers would not be applicable or expected for this device's stated function.

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

The primary performance evaluation for the blood pressure measurement was the "accuracy" against the reference standard (ISO 81060-2:2018), which is a standalone performance assessment of the device's ability to accurately measure BP. For ECG, the compliance to IEC 60601-2-47 further indicates a standalone performance assessment of its signal acquisition capabilities.

7. The type of ground truth used

The ground truth for blood pressure measurements was established using:

• Expert Consensus/Reference Measurement: Simultaneous auscultatory reference BP measurements taken by two trained observers (using a calibrated standard aneroid sphygmomanometer and a dual-head teaching stethoscope). This aligns with the "expert consensus" category for reference standard measurements in clinical studies of measurement devices.
• Standardized Method: The "same arm sequential method" described in the ISO 81060-2:2018 Universal Standard.

8. The sample size for the training set

The document does not specify a training set or its sample size. This is typical for medical devices that are not "machine learning/AI" devices requiring a distinct training and test split for an algorithm. The "ABPMpro" is presented as a measurement and recording device, not one with a diagnostic AI algorithm that learns from data.

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

As no training set is mentioned (see point 8), this information is not applicable.

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The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

Not Found

This FDA 510(k) clearance letter for the Bardy Diagnostics Carnation Ambulatory Monitor does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them.

The document is an FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It refers to general controls, quality system regulations, and provides contact information for regulatory inquiries.

Specifically, the letter does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. This information would typically be found in the 510(k) submission itself, not the clearance letter.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this type of detailed performance data and study design, one would typically need to review the full 510(k) submission available through the FDA's public database (though not all components of the submission are always publicly accessible in detail). The provided document is a summary clearance letter.

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The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.

Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) is composed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressure adopts the principle of the oscillometric method for non-invasive blood pressure measurement. ECG signals are obtained by placing electrodes on the patient's surface to record the potential change signal of the human heart and then processing the data to form an ECG waveform and store it in the Recorder to monitor the ECG signal.

The provided text describes the Holter ECG and ABP System and its performance data to establish substantial equivalence to predicate devices. However, the document does not contain an acceptance criteria table or specific details of a study directly proving the device meets acceptance criteria in the format often associated with AI/ML algorithm validation (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on non-clinical performance testing to demonstrate the device's adherence to relevant industry standards and functional specifications, ensuring its safety and effectiveness are comparable to the predicate devices.

Here's a breakdown of the information that can be extracted or inferred based on common medical device submission practices, acknowledging that explicit details on some points are missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal "acceptance criteria" table in terms of diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluations are based on compliance with established medical device standards. The "reported device performance" is the successful compliance with these standards.

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

The document states, "Clinical data: Not applicable," implying that the assessment for this 510(k) submission did not involve a clinical trial or a test set derived from patient data in the typical sense of evaluating diagnostic accuracy. The testing was primarily bench-based and software verification. Therefore, there's no "sample size for a test set" or "data provenance" related to patient data for diagnostic performance evaluation.

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 test set for diagnostic performance was used. The "ground truth" for the non-clinical testing was defined by the specifications and requirements of the referenced industry standards.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance was used.

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 device is a Holter ECG and ABP system (hardware for acquisition, storage, and display of physiological signals), not an AI/ML diagnostic algorithm designed to assist human readers or perform automated interpretations beyond basic parameter measurements.

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

Not applicable. This is not an AI/ML algorithm in the context of diagnostic interpretation. It is a device for signal acquisition and measurement. The "algorithm" for NIBP (oscillometric method) and ECG signal processing is inherent to the device's function, but it's not described as a standalone diagnostic algorithm requiring performance evaluation against a specific ground truth like an AI model would be.

7. The type of ground truth used

For the performance testing, the "ground truth" was the specifications and requirements defined by the referenced international and national consensus standards (e.g., IEC 60601 series, ANSI AAMI standards). The device's measurements (ECG signals, blood pressure) are verified against the expected outputs and accuracy tolerances dictated by these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm that requires a training set of patient data.

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

Not applicable. This is not an AI/ML algorithm that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the document):

The "study" proving the device meets its "acceptance criteria" is a series of non-clinical performance tests and software verification and validation activities designed to demonstrate compliance with recognized medical device standards.

1. Electrical Safety and EMC Testing: The device was tested against ANSI AAMI ES 60601-1 and IEC 60601-1-2 to ensure it is electrically safe and does not cause or succumb to electromagnetic interference.
2. Performance Testing (Bench): Functional and system-level bench testing was conducted to validate the device's performance against the accuracy specifications and requirements outlined in:
   • IEC 60601-2-47: For ambulatory electrocardiographic systems (ECG Holter functionality).
   • IEC 80601-2-30: For automated non-invasive sphygmomanometers (ABP functionality).
   • ANSI AAMI EC53: For ECG trunk cables and patient leadwires.
   • IEC 60601-1-11: For devices used in the home healthcare environment.
     These tests would involve simulating physiological signals or using calibrated equipment to ensure the device accurately acquires, processes, and displays ECG and ABP data within acceptable error margins defined by these standards.
3. Software Verification and Validation: This involved rigorous testing of the device's embedded software to ensure it functions as intended, is free from critical bugs, and meets specified requirements, following FDA guidance for software in medical devices.

The conclusion drawn from these "non-clinical data" is that the "subject devices are as safe and as effective as the predicate device," thus establishing substantial equivalence for market clearance.

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S-Patch Ex wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.

The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.

The provided text is a 510(k) summary for the S-Patch Ex Wearable ECG Patch. It describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria for a performance study or the results of such a study in terms of quantifiable metrics like accuracy, sensitivity, or specificity against established ground truth.

The document states that "Multiple system performance testing was successfully performed, demonstrating comparative performance against traditional multi-leads ECG monitors and acceptable electrode placement performance. An integration testing was also conducted, demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms." but it does not provide the actual data or specific acceptance criteria for these tests.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. The document focuses on demonstrating substantial equivalence through similar indications for use, technological characteristics, and conformance to general device standards (biocompatibility, electrical safety, software V&V, cybersecurity, human factors). It explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." This means a formal comparative effectiveness study against human readers or a standalone algorithm performance study with a defined ground truth and statistical metrics was not performed for this 510(k) submission.

Here's what can be inferred or stated as not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any performance testing.
• Data Provenance: Not specified. (The document mentions the manufacturer is in the Republic of Korea, but no information on data origin is provided).
• Retrospective/Prospective: Not specified.

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

This information is not available as the document does not describe a clinical study with ground truth established by experts for performance evaluation. The device does not include automated ECG analysis and relies on "further analysis and interpretation by qualified medical professionals" using 3rd-party platforms.

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

Not applicable/Not available. No clinical study with expert adjudication is described for performance evaluation.

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. The document explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." Furthermore, the S-Patch Ex "does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software." Therefore, no MRMC study involving AI assistance would have been conducted or reported here.

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

No. The device itself does not perform automated ECG analysis. Its function is to collect and transmit ECG data.

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

Not applicable/Not available. As no clinical performance study requiring ground truth was presented, this information is not provided. The performance testing appears to be primarily technical (signal quality, electrical safety, software functionality), not diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

Not applicable/Not available. This device is a data collection device and does not inherently involve an AI algorithm that would require a "training set" for diagnostic performance.

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

Not applicable/Not available. (See point 8).

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The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis.

The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components:

1. AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth.

2. AeviceMD Silicone Patch - silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin.

3. AeviceMD Docking Station - gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charqer for the Sensor.

4. AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals in a clinical setting) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting.

5. AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

The AeviceMD is a non-invasive, battery-operated device intended to acquire, record, and store lung sounds from adult patients for later review and analysis by a clinician.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical performance tests but does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance values in a table format for the device's primary function of acquiring and recording lung sounds.

However, based on the non-clinical performance data section, the device likely aims to perform "as well as" a legally marketed predicate device, implying equivalence in its core function. The "Stethoscope Performance Test against a 510(k) cleared reference stethoscope" suggests that the AeviceMD's acoustic performance was compared to an already cleared device.

Implicit Acceptance Criteria (inferred from the document):

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

The document does not specify the sample size for any "test set" in the context of clinical or performance data for lung sound acquisition accuracy. The studies mentioned are primarily non-clinical validation tests (e.g., biocompatibility, electrical safety, usability, software, shipping, cleaning, frequency response, stethoscope performance comparison). These typically involve specific test conditions and components rather than human subject data sets in the way an AI algorithm test set would.

For the "Stethoscope Performance Test against a 510(k) cleared reference stethoscope", the exact number of data points or recordings used for comparison is not provided.

The data provenance for these non-clinical tests is not explicitly stated in terms of country of origin but would generally originate from the manufacturer's testing facilities or accredited third-party labs carrying out these standardized tests. The studies are described as "non-clinical performance data," implying laboratory or engineering testing rather than retrospective or prospective clinical human studies to evaluate diagnostic performance.

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 in the document. The document describes a device for acquiring, recording, and storing lung sounds for later playback, review, and analysis by a clinician. It does not mention any automated interpretation or diagnostic capabilities that would necessitate a ground truth established by experts interpreting sounds. Therefore, there's no mention of experts establishing a ground truth for diagnostic accuracy for the device itself.

4. Adjudication method for the test set

Not applicable, as no expert-adjudicated test set for diagnostic performance is mentioned.

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 mentioned. The device's indications for use emphasize acquisition, recording, storage, playback, and review by a clinician, not AI-assisted interpretation or diagnosis. There is no mention of AI features intended to improve human reader performance.

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

No standalone algorithm performance study is mentioned. The device is a "Medical Magnetic Tape Recorder" and "Stethoscope, Electronic" intended for clinicians to interpret the recorded sounds, not for an algorithm to provide a standalone diagnosis. The device's cloud platform "analyzes user's data using meaningful output information," but the nature of this "meaningful output" is not specified to be diagnostic or requiring standalone performance evaluation in the context of this 510(k) summary.

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

Not applicable, as the device doesn't have a stated diagnostic function that requires ground truth for clinical accuracy. The "Stethoscope Performance Test" would likely use a reference cleared stethoscope as its "ground truth" for acoustic fidelity, rather than clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable. The document does not describe the development or evaluation of a machine learning algorithm for diagnostic purposes that would require a "training set." The "AeviceMD Cloud Platform" is mentioned to "analyze user's data using meaningful output information," but the details of this analysis, particularly if it involves machine learning and a corresponding training set, are not provided or assessed in this 510(k) summary for substantial equivalence.

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

Not applicable, as no training set for a diagnostic algorithm is mentioned.

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