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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 Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented for review by a medical professional. The data received from the Rhythm Express device can be used by another compatible device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to be used as part of an alarm system or for active patient monitoring.

The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.

This device is not intended for patients in whom quantification of triplets/couplets is needed.

The RX-1 mini Rhythm Express Remote Cardiac Monitoring System (RCMS) is a multiple function device consisting of three components: 1) the RX-1 mini remote cardiac monitoring device ("RX-1 mini device") with on-board ECG waveform analysis algorithm, 2) the Web Service (RS-1) with server and database, and 3) back-office software (Operator Portal and Clinic Portal). The RS-1 server, Operator Portal, and Clinic Portal are non-device software functions.

The RX-1 mini device is worn by patients for a period of time as prescribed by a physician, up to 30 days, and continuously monitors ECG. The RX-1 mini device functions in one of three modes: a) Outpatient Cardiac Telemetry (OCT), b) Event Recorder (ER), and c) Wireless Holter monitor (WH). The device connects to standard ECG electrodes to capture 2 channel ECGs. The embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. The RX-1 mini device incorporates a cellular modem and Wi-Fi to communicate with the RS-1 Web Service.

The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements.

This FDA 510(k) clearance letter and summary does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.

The provided document primarily focuses on:

• Regulatory information: Clearance letter, product codes, classification, and applicable regulations.
• Device comparison: High-level overview of similarities and differences with the predicate device.
• General performance testing: A list of standards to which various tests were conducted (EMC, electrical safety, biocompatibility, software functionality, etc.), but not the specific results or acceptance criteria for those tests.
• Indications for Use: Clarification on the intended purpose of the device.

Crucially, it lacks the detailed information about the clinical study, including:

• Specific acceptance criteria for clinical performance: While it mentions "ECG algorithm performance," it doesn't state what metrics (e.g., sensitivity, specificity for arrhythmia detection) were used or what the target values were.
• Reported device performance values: There are no tables or explicit statements of the device's accuracy for detecting specific cardiac events.
• Test set details: No information on sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for the clinical performance study.
• Training set details: No information on the training data size or how its ground truth was established.
• MRMC study: There's no mention of a human-in-the-loop study comparing human readers with and without AI assistance.
• Standalone performance: While it alludes to "ECG algorithm performance," it doesn't explicitly state the results of a standalone algorithm performance study.

Therefore, based solely on the provided text, I cannot create the table of acceptance criteria and reported performance, nor can I fully describe the study in the detail you requested.

The document states: "Performance testing verifies that the RX-1 mini Rhythm Express RCMS meets performance specifications." and "Performance testing data demonstrate that the subject device is as safe, and as effective, as the predicate device." This implies that such data exists and was submitted to the FDA, but it is not included in this public-facing summary.

To meet your request, one would typically need access to the full 510(k) submission, which would include detailed study reports, statistical analysis plans, and performance data.

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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 Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of:

• Symptoms that may be related to rhythm disturbances of the heart in adult patients.
• Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional.
• Efficacy of antiarrhythmic therapy
• Pacemaker function
• Symptoms that may be associated with myocardial ischemia

The Philips Holter Analysis System is not intended for use for pediatric patients.

The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters:

• Age: Between 33 to 82 years
• Height: Between 147 to 185 cm (58 to 73 inches)
• Weight: Between 53 to 118 kg (117 to 261 lbs)
• Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

The Philips Holter Analysis System (hereinafter known as Philips HAS) is offered as standalone software. It is intended to be installed into a user's PC (general purpose computing platform). The product evaluates the heart rhythms of ambulatory ECG data over an extended period and generates a preliminary analysis for physician's review. The ECG data is downloaded from compatible ambulatory ECG recorders. It is to be used by trained personnel.

The Philips Holter Analysis System accepts ECG recordings from DigiTrak XT recorders (K071733) and analyzes the patient's heart activity for the recorded period, typically from 24 hours up to 7 days. The analysis is not performed in real time. The DigiTrak XT recorder collects up to 168 hours (7 days) of ambulatory ECG. The software can analyze up to 168 hours (7 days) of contiguous ECG data.

The algorithm (Zymed Algorithm, also internally referred to as the CAlg-Holter Algorithm) used in Holter Analysis System was first developed and approved for use in the Holter Scanner Model 1210. It was continually updated and subsequently cleared for use in more Holter Models. It includes Heart Rate Variability (Time Domain) as a standard software report configuration in March 1996. The operating system converted from a DOS operating system to a Windows operating system in April 1999. Heart Rate Variability Frequency Domain was added in February 2001. The QT analysis was added in September 2001. The most recent 510(k) including above features and functions is under K010949.

The Zymed Algorithm in the HAS incorporates the following enhancements in the subject device:

• Upgraded AFIB detection by replacing the current algorithm with the Philips ST/AR AFIB algorithm's P wave detection feature. The feature was cleared in K101521 with Philips ST/AR ST and Arrhythmia Software.
• Enhanced HRV reporting by replacing current calculations with advanced data warehouse calculations from PhysioNet. Incorporated Nonlinear HRV to provide more characterization of heart rate variability that linear methods could miss.
• Incorporated bug fix, and code security
• Upgraded compiler

The EASI derived 12-lead display function was cleared in K020456. It remains unchanged in the subject device. Philips does not incorporate any additional usage in the subject device beyond these clearances. The EASI 12-lead is only for display purposes, allowing end users to visualize EASI lead ECG recordings in a traditional 12-lead format. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

No automatic functions or analyses utilize this data. The Zymed Algorithm performs its analysis on the raw ECG signal and does not use the EASI derived 12-lead in that analysis.

The Philips Holter Analysis System requires operator's intervention during and after the initial analysis. The Philips HAS allows the operator to view and print out an analysis report, individual heart rate strips, as well as a full disclosure report for physician's review, diagnoses, and observations. It is intended to assist the qualified medical professional in the interpretation of the recorded data; it is not intended to serve as a substitute for the review and overread of the recorded ECG data.

The Philips Holter Analysis System provides viewing, printing, and report capabilities as listed below:

• A view of the data and a summary of the heart events that have taken place
• Detection of anomalies such as ventricular ectopy and supraventricular ectopy
• Patency of the pacemaker and pacemaker anomalies
• Advanced scanning techniques, such as determining ST and QT anomalies
• Heart rate data and heart rate variability
• Full disclosure reports

The Philips Holter Analysis System can operate in a networked environment that includes the following devices and interfaces to transfer orders and Holter reports.

• Philips IntelliVue Information Center (PIIC) (K153702)
• A fleet of Holter Remote Links and one or more Holter Central Links
• IntelliSpace ECG Management System (ISECG) (K120855)
• An IntelliBridge Enterprise (IBE) data interface engine / brokering system
• DICOM-based enterprise systems

PIC , Holter Remote Links, and Holter Central Links provide alternate ECG input mechanisms for Holter analysis. ISECG Central Link, Report Viewer, and IBE can accept Holter reports. IBE can provide Orders and ADT information for HAS. DICOM-based systems support patient orders via DICOM Modality Worklist and accept exported DICOM Encapsulated PDF reports.

The Philips Holter Analysis System provides three models with different configurations for customers to select: Series 3000, Series 5000, and Series 7000.

The provided text does not contain detailed acceptance criteria or a comprehensive study plan that proves the device meets specific performance metrics in the format of a clinical or analytical validation study for an AI/ML medical device.

The document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the Philips Holter Analysis System to a predicate device (2010 Plus Holter for Windows, K010949). The information provided focuses on:

• Device Description and Intended Use: The Philips Holter Analysis System analyzes ambulatory ECG data for various cardiac parameters. It incorporates updated algorithms (e.g., ST/AR AFIB algorithm's P wave detection, enhanced HRV reporting) and supports interoperability. It is intended for adult patients and trained clinicians.
• Comparison to Predicate Device: Detailed tables compare the subject device's indications for use, target population, intended user, intended use environment, and various technological characteristics (e.g., Holter applications, EASI Hookup, supported channels, analysis configuration, arrhythmia and event detection, QT/ST analysis, Pacemaker analysis, Caliper, Important Events, Report Output, Supported ECG source) to the predicate.
• Performance Data Summaries: It states that the device "successfully passed all the testing conducted, and the results demonstrated the Philips Holter Analysis System meets the performance claims and supports a determination of substantial equivalence to the predicate device."
• Non-Clinical Tests - Standards: It lists compliance with several recognized standards (ISO 14971, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 60601-2-47, AAMI EC57). These standards cover risk management, software lifecycle, health software safety, usability engineering, and requirements for ambulatory electrocardiographic systems.
• Non-Clinical Bench Tests: It broadly states that the device was "evaluated against all applicable standards and internal procedures and successfully passed all verifications and validations. The results demonstrated that Philips Holter Analysis System meets all claims and supports a determination of substantial equivalence to the predicate."
• Clinical Studies: It explicitly states that "The Philips Holter Analysis System, like the predicate device, does not require clinical trials."

Missing Information:

The document does not provide the following specifics required to answer your prompt:

• A table of acceptance criteria and reported device performance: While it mentions "performance claims," the actual criteria (e.g., sensitivity, specificity, accuracy targets for specific arrhythmia detection) and the quantitative results are not in the document.
• Sample size used for the test set and data provenance: No details on the size or origin of any specific test datasets used for performance evaluation of the algorithmic changes.
• Number of experts used to establish ground truth and their qualifications: No information on how ground truth was established for any internal performance testing.
• Adjudication method for the test set: No mention of adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states no clinical trials were required. Thus, no MRMC study details are available.
• Standalone (algorithm only) performance: While the document describes software updates, it does not explicitly provide standalone performance metrics for the AI/ML components (like the upgraded AFIB detection or enhanced HRV). The entire device is presented as assisting clinicians, not replacing them.
• Type of ground truth used: No specific type of ground truth is detailed for performance evaluation, beyond stating it passed internal verification and validation against claims.
• Sample size for the training set: No information on training data is provided.
• How ground truth for the training set was established: No information on this.

Conclusion based on the provided text:

The Philips Holter Analysis System received 510(k) clearance based on substantial equivalence to a predicate device, supported by compliance with recognized standards and successful completion of non-clinical bench testing, software verification and validation, usability validation, and risk management activities. This regulatory pathway typically does not require extensive clinical trial data detailing specific algorithmic performance metrics or human-AI interaction studies as might be submitted for novel AI/ML devices with significantly different indications or technological characteristics. The document emphasizes adherence to engineering and quality standards, and broad performance claims rather than specific quantitative performance targets and studies.

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The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.

The provided document describes the FDA 510(k) premarket notification for the Frontier X Plus device. It does not contain a specific table of acceptance criteria with reported device performance results, nor does it detail a multi-reader, multi-case (MRMC) comparative effectiveness study or provide effect sizes for human readers with AI assistance.

However, based on the Clinical Testing Summary section on pages 10-11, we can infer information about the study design that proves the device meets certain performance criteria.

Here's an attempt to structure the available information per your request:

Acceptance Criteria and Device Performance Study

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes a clinical investigation designed to demonstrate "substantial equivalence" to a predicate device, focusing on the ability of the device's algorithm to accurately detect and classify ECG rhythms.

Inferred Acceptance Criteria & Reported Device Performance (Qualitative)

Study Details:

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

   • Test Set Sample Size: A total of 832 users were included in the Study population for the clinical investigation.
   • Data Provenance: The document does not specify the country of origin for the data. It seems to be a prospective study as it describes the conduct of a clinical investigation where ECGs "were collected and analyzed at various time points."

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

   • The document implies that the ground truth for the rhythm analysis (Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive, noisy/unreadable signals) was established by comparison to a "standard 12-lead ECG device."
   • It also states that the "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience." This suggests that physicians (likely cardiologists or electrophysiologists) were the experts, but the number of experts and their specific qualifications (e.g., years of experience) are not explicitly stated for ground truth establishment within the study.

3. Adjudication Method for the Test Set:

   • The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set. It suggests that the 12-lead ECG served as the reference standard.

4. 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, a MRMC comparative effectiveness study was not explicitly described or summarized in this document. The study focused on the device's (algorithm's) performance against a reference standard, not on how human readers' performance might improve with the device's assistance.

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

   • Yes, a standalone performance evaluation of the algorithm appears to have been a primary component of the clinical investigation. The study "evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device." This describes the algorithm's performance independent of human readers.

6. The Type of Ground Truth Used:

   • The primary ground truth used was simultaneously acquired signals from a standard 12-lead ECG device. This can be considered a form of clinical standard/reference data. The document also mentions that a "physician who will render a diagnosis based on clinical judgment and experience" reviews the reported information, implying physician interpretation as a ground truth for final diagnosis.

7. The Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set of the algorithm. It only discusses the clinical investigation/test set.

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

   • The document does not provide information on how the ground truth for the training set was established, as it focuses on the validation study and not the algorithm development process.

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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. 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, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing. The Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zio AT device, organized as requested:

Device: Zio AT® device (A100A1001)

This premarket notification (K240177) is for an updated version of an already cleared device (Zio® AT ECG Monitoring Device [K240029]). Therefore, the submission primarily focuses on demonstrating substantial equivalence to the predicate device through non-clinical testing rather than presenting new clinical study data with detailed acceptance criteria and performance metrics for the device's diagnostic capabilities. The document explicitly states: "No clinical testing was performed in support of this premarket notification."

As such, many of the requested details related to clinical performance, such as detailed acceptance criteria tables, sample sizes for test sets, expert qualifications, and MRMC studies, are not available in this 510(k) summary. The acceptance criteria described here pertain to safety and engineering standards, not clinical accuracy for arrhythmia detection.

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

Since this is a 510(k) for substantial equivalence based on non-clinical testing for an updated device, the "acceptance criteria" are predominantly for engineering and safety standards, and the "reported performance" is that the device conforms to these standards.

Regarding the study that proves the device meets the acceptance criteria:

The study referenced is a comprehensive set of nonclinical performance testing. The document states: "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

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 applicable/not provided for clinical performance. The nonclinical testing involves evaluating the physical device and its software against engineering standards. The sample size would refer to the number of devices or components tested to ensure compliance with specific technical standards (e.g., a certain number of units for electrical safety testing, material samples for biocompatibility), but specific quantities are not detailed in this summary.
• Data Provenance: Not applicable, as this is nonclinical (engineering/safety) 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)

Not applicable, as this document focuses on nonclinical testing and substantial equivalence, not clinical diagnostic performance requiring expert interpretation as ground truth.

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

Not applicable, as this document focuses on nonclinical testing, not clinical performance where adjudication of "ground truth" labels would be necessary.

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 or reported in this 510(k) summary. This submission explicitly states "No clinical testing was performed in support of this premarket notification." The Zio AT device uses an arrhythmia detection algorithm (provided by the interoperable ZEUS SaMD), but the evaluation here is for the physical device's safety and engineering, not the diagnostic performance of the AI component.

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

This document does not provide details on standalone algorithm performance. The "Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting." While an algorithm exists, its performance is not detailed or assessed in this specific 510(k) submission as the focus is on the physical hardware's substantial equivalence to a predicate. Evaluations of the ZEUS SaMD's algorithm (which likely includes standalone performance) would have been part of previous submissions for that software.

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

For the nonclinical testing described, the "ground truth" would be the defined standards and specifications (e.g., a device passes the electrical safety test if it meets the voltage and current limits specified in IEC 60601-1). This is not clinical ground truth.

8. The sample size for the training set

Not applicable/not provided. This submission does not discuss the training of any AI algorithm, as it's a 510(k) for an updated physical device and primarily addresses nonclinical performance and substantial equivalence based on engineering and safety standards.

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

Not applicable/not provided for the same reasons as #8.

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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. 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, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing.

The provided document, a 510(k) Summary for the Zio AT® device (K240029), states that no clinical testing was performed in support of this premarket notification. The submission relies solely on nonclinical testing to demonstrate substantial equivalence to the predicate device (Zio® AT ECG Monitoring Device [K163512]).

Therefore, based on the provided text, I cannot provide details regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance that would typically be associated with clinical studies.

The document indicates that the device's acceptance criteria were based on its conformance to established performance specifications and FDA-recognized consensus standards. The study that proves the device meets these acceptance criteria is the nonclinical testing described.

Here's an overview of the information available:

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

The document does not provide a specific table of quantitative acceptance criteria and reported device performance metrics in the format typically seen with clinical study results (e.g., sensitivity, specificity, accuracy for arrhythmia detection). Instead, it states that "All necessary performance testing was conducted on the Zio AT device to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device."

The acceptance criteria implicitly relate to the successful completion of the following nonclinical tests and their conformance to specified standards:

• System performance testing: This would ensure the device functions as designed in various operational aspects.
• Biocompatibility testing: This confirms the materials used in the device are safe for contact with the human body.
• Firmware verification testing: This validates the software operating the device.
• Electrical safety and EMC testing: This ensures the device is electrically safe and does not interfere with other electronic devices, and vice versa.

The reported device performance, in this context, is that the device "meets the requirements of established conformance standards and performance specifications necessary for its intended use."

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

Not applicable, as no clinical testing was performed. The nonclinical testing would use various test samples and equipment as dictated by the specific standards and internal protocols, but these are not disclosed in terms of number or provenance in the provided summary.

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 applicable, as no clinical testing with expert ground truth establishment was performed.

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

Not applicable, as no clinical testing requiring 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

Not applicable, as no clinical testing or MRMC study was performed. The Zio AT device itself functions as a monitoring and transmission system, not an AI-powered diagnostic aid that assists human readers in real-time interpretation.

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

The device is described as "intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data." While it transmits events, the overall system for diagnosis involves a monitoring center for analysis and end-of-wear reporting, which would typically involve human oversight. The provided text does not suggest a standalone algorithm-only diagnostic performance evaluation in a clinical setting. The nonclinical testing focused on the device's functional performance and compliance with relevant standards.

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

Not applicable, as no clinical testing that would require such ground truth for diagnostic accuracy was performed. For nonclinical tests, the "ground truth" would be the specified parameters and expected outputs defined by the relevant engineering and safety standards.

8. The sample size for the training set

Not applicable, as no clinical testing or development of an AI algorithm based clinical data was detailed as part of this submission for demonstrating substantial equivalence. The device is an updated version of a previously cleared device, focusing on hardware and firmware changes.

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

Not applicable for the same reasons as #8.

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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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The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.

The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.

The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time).

The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience.

The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time.

The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components:

• Monitor Cable Assembly
• Hub
• Alert Button
• Battery Pack
• SensorFit™ Garment
• Charger

The Kestra Medical Technologies, Inc. ASSURE Wearable ECG (K233864) does not appear to have an artificial intelligence/machine learning component that offers diagnostic interpretation. The provided text states, "The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements, or provide for any life support." and "The ASSURE Wearable ECG event reports do not contain diagnostic interpretation." Therefore, the typical acceptance criteria and study designs for AI/ML devices might not be applicable in the usual sense.

However, based on the information provided, here's a breakdown regarding the device's technical performance and regulatory compliance, reinterpreting "acceptance criteria" through the lens of general medical device performance and safety standards:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements, traditional AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth would not be applicable here. Instead, the acceptance criteria are focused on the device's ability to reliably act as a continuous ECG monitor, data recorder, and transmitter, and its compliance with relevant safety and performance standards.

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

The provided text does not explicitly state the sample size for any clinical or technical test sets involving patient data. The performance section focuses on bench testing against recognized standards. There is no mention of a separate "test set" in the context of diagnostic accuracy from patient data, as the device doesn't provide diagnostic interpretation.

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

This information is not applicable as the device explicitly states it does not perform automated or semi-automated analysis or provide diagnostic statements. The "ground truth" here is primarily established by adherence to engineering and safety standards, and functional verification through bench testing. Clinical interpretation of the recorded ECG data is left to medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable given the device's stated function and the type of performance testing described (bench testing against engineering standards, not diagnostic accuracy studies requiring expert adjudication).

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

No, a MRMC comparative effectiveness study was not conducted or described. The device's function is to record ECG data, not to interpret it or assist human readers in interpretation. There is no AI component in this device that provides diagnostic assistance to a human reader.

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

While the device uses an "embedded arrhythmia detection algorithm" for auto-triggering events (high and low heart rates), the submission explicitly states that the signal "is not intended and should not be used for automated or semi-automated analysis" and "does not deliver...interpretive or diagnostic statements." Therefore, a standalone performance study in the sense of evaluating the diagnostic accuracy of an AI algorithm was not performed because the device does not claim diagnostic capabilities. Its "algorithm detection and episode reporting software" is for capture and storage of events for later clinician review, not for automated diagnosis.

7. Type of Ground Truth Used

For the functional aspects (ECG monitoring, event triggering, data storage/transmission), the "ground truth" would have been established through instrumentation calibration, controlled simulated signals, and direct measurement during bench testing, verifying that the device accurately records ECG, identifies specified rate thresholds, and transfers data as intended. For the safety and performance standards (e.g., IEC 60601 series), the ground truth is adherence to the requirements and test methods outlined in those international standards.

8. Sample Size for the Training Set

This information is not applicable. The device, as described, does not utilize machine learning/AI for diagnostic purposes, and therefore would not have a "training set" in the context of developing a diagnostic algorithm. The "proprietary algorithm detection software" for event triggering, while an algorithm, is not presented as a machine learning model requiring a training set for diagnostic output.

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

This information is not applicable. As no machine learning-based diagnostic algorithm is described, there is no "training set" or corresponding ground truth establishment process mentioned.

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