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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 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 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 device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms.

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.

The Rhythm Express RX-1 will be worn by patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service.

The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

The provided text is a 510(k) Pre-market Notification for the RX-1 Rhythm Express Remote Cardiac Monitoring System. It does not contain a detailed study report with acceptance criteria and a comprehensive breakdown of device performance as one might find in a clinical trial summary.

However, based on the information provided, here's a summary of the performance testing and how it relates to general acceptance in regulatory submissions:

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

The document does not present a formal table of explicit acceptance criteria and corresponding performance metrics for the device's accuracy in arrhythmia detection or analysis. Instead, it refers to successful completion of various performance and safety standards, and general functional verification.

• IEC 60601-1-1:2012 Ed. 3.1: Passed. (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 4th Edition: Passed. (Electromagnetic compatibility)
• IEC 60601-1-11:2015 Edition 1.1: Passed. (Requirements for home healthcare environment)
• ISO 10993-1: Biocompatibility testing of patient contacting materials passed. |
  | Software Life Cycle | - IEC 62304:2015 Ed. 1.1: Passed. (Medical Device Software Software Life Cycle Processes) |
  | Security Risk Management | - ANSI/AAMI TIR57:2015: Passed. (Principles for medical device security-Risk management) |
  | Usability | - IEC 62366-1:2015 Edition 1.0: Passed. (Application of usability engineering to medical devices) |
  | Wireless Coexistence | - ANSI IEEE C63.27-2017: Passed. (Evaluation of Wireless Coexistence) |
  | Functional Performance (Specific to Monitoring System) | - Bench test results verified: The RX-1 Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto-activated event recordings to the server via mobile network connection for evaluation by a medical professional.
• Conclusion: All requirements were met, and the RX-1 Monitor performs as designed. (Does not explicitly list quantitative performance metrics for arrhythmia detection accuracy, sensitivity, specificity, etc.) |

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

The document primarily discusses bench testing and compliance with standards. There is no mention of a clinical test set involving human subjects, nor any details about data provenance (country of origin, retrospective/prospective). The performance claims are based on engineering bench tests and adherence to recognized standards.

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)

Since the testing primarily involved bench tests and compliance with standards, the concept of "ground truth" as established by medical experts for a clinical dataset is not applicable here. The "ground truth" for the functional tests would be the expected behavior of the device as per its design specifications.

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

Not applicable, as there's no mention of a clinical test set requiring expert adjudication.

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 such study is mentioned or implied in the provided text. The device is referred to as an "ECG analysis algorithm" that detects arrhythmias, but its impact on human reader performance is not evaluated in this submission summary.

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

The document states: "An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology." It also mentions that "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."

This indicates that the algorithm performs standalone detection, and then the data is presented for human review. However, the submission does not provide specific performance metrics for this standalone algorithm (e.g., sensitivity, specificity, PPV for various arrhythmias). The "bench test results verify that RX-1 Monitor system can continuously record ECG signal... and transmit manual or auto activated event recordings to the server for evaluation by a medical professional" confirms the functional aspect of the algorithm's automatic detection and transmission.

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

For the functional bench tests, the "ground truth" would be the engineering specifications and expected signal characteristics. For instance, testing noise reduction or signal recording accuracy would compare the device's output against known input signals or precise measurement standards. There's no mention of medical ground truth (e.g., expert-annotated ECGs, pathology, or outcomes) used to validate the arrhythmia detection algorithm's accuracy.

8. The sample size for the training set

The document does not provide details about a training set for the embedded ECG analysis algorithm. It is a 510(k) submission focused on substantial equivalence to predicate devices and adherence to performance standards, rather than a detailed algorithm validation report.

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

Not applicable, as no information regarding a training set is provided.

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CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings.

CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device.

The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients.

Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.

CER-S analysis provides indications for, but not limited to, evaluation of:

• Patients with rhythm disturbances (cardiac arrhythmias),
• Patients with transient myocardial ischemia,
• Patients with pacemaker (only if pacing detection is available from the input recording),
• Patients needing HRV evaluation,
• Newborn patients limited to QRS detection.

CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER).
Different modules provide:
ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows interactive Continuous ECG Viewer interactive display/management of ECG Templates Holter-like report for analyzed Continuous ECG records, record exportation, in ISHNE format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse.
Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.
Moreover, CER-S allows the automatic analysis for the following patch location:
two-electrode patches positioned in the left upper chest area at a roughly inclined angle three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum
In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.

The provided text does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for the CER-S device, which outlines its purpose, regulatory information, and a high-level overview of some testing. However, it explicitly states: "No clinical tests were performed to demonstrate safety and effectiveness of CER-S". This means there was no clinical study with human participants to measure the device's performance against specific acceptance criteria in a real-world setting.

Instead, the submission relies on non-clinical tests (performance testing against existing standards and software development life cycle adherence) and substantial equivalence to a predicate device.

Therefore, I can only provide information based on what is available in the text. Many of your requested points will be answered with "Not applicable" or "Information not provided in the document."

Here is the breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (CER-S)

As stated in the 510(k) Summary, no clinical tests were performed to demonstrate the safety and effectiveness of CER-S. The submission relies on non-clinical performance testing and software development life cycle adherence to established standards, as well as arguments for substantial equivalence to a predicate device. Therefore, a study demonstrating the device meets performance acceptance criteria via a clinical trial with human-in-the-loop or standalone AI performance metrics is not detailed in this document.

The document mentions compliance with several non-clinical standards for ECG performance and software development. These standards inherently have their own acceptance criteria, but the specific performance results against these criteria are not numerical values reported in a table within this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical study measuring specific performance metrics against clinical acceptance criteria was conducted and detailed in this summary, a table of this nature cannot be generated from the provided text. The document states:

• "The following non-clinical tests have been conducted on the Subject Device:
  • ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105)
  • Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32)
  • Usability engineering process, according to: IEC 62366:2007"
• "The testing demonstrated that CER-S is safe and effectiveness for the propose intended use."

While these standards contain acceptance criteria for the device's functions (e.g., ECG signal processing accuracy, software robustness), the specific quantitative results are not reported in this summary.

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

• Sample Size (Test Set): Not applicable, as no clinical test set/study is detailed. The non-clinical tests would have used synthetic or recorded ECG data, but the "sample size" of such data is not specified.
• Data Provenance: Not applicable for a clinical test set. The document refers to "data acquired from electrodes with conductive paste/gel... from any device used for the arrhythmia diagnostics." The origin (country, retrospective/prospective) of this data, if used for internal validation, is not specified.

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

• Number of Experts: Not applicable, as no clinical test set/study requiring expert ground truth is detailed.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no clinical test set/study is detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or detailed for AI assistance versus human-alone performance. The device is described as an "additional tool to aid in the interpretation of ECG data" and explicitly states it "does not provide an automated interpretation and is not intended for use as the only diagnostic tool." This suggests it's an analysis and review tool, not a standalone AI diagnostic.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No, a standalone (algorithm only) performance study in the sense of an AI diagnostic evaluating cases without human intervention is not described. The device is a software suite for analyzing, editing, reviewing, and reporting, implying human interaction. It also explicitly states it "does not provide an automated interpretation."

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a clinical study. For the non-clinical ECG performance testing, the ground truth would be defined by the known characteristics of the ECG signals and simulated arrhythmias as per the testing standards (e.g., ANSI/AAMI EC57).

8. Sample Size for the Training Set

• Sample Size (Training Set): Not provided. The document describes the device as a "tool, designed to offer a framework for the interaction of different software-modules," some of which perform "ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection." While these functions imply some form of algorithm or model development, the document does not specify if or how an explicit "training set" (in the machine learning sense) was used, nor its size.

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

• Ground Truth Establishment (Training Set): Not provided. If algorithms within the software were developed using training data, the method for establishing ground truth for such data is not described in this summary.

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The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.

Faros Mobile provides the detection and reporting features appropriate for the indications below

• · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
• · Evaluation of patients for ST segment changes
• · Evaluation patients with pacemaker
• · Evaluating patient rest and stress ECG
• · Reporting heart rate variability analysis
• · Wireless transmission of patient ECG data and arrhythmia events for further analysis.

Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.

Faros Mobile is contraindicated for

• · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
• · Pediatric patients weighting less than 10 kg

Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes.

Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software.

In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes.

Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application.

Faros Mobile system consists of:

• . Faros ECG sensor
  • o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor
  • channel and 3-channel cable sets o
  • general micro-USB cable for recharging device O
• Faros Manager application
• Cardiac Explorer application
• Cardiac Navigator application

The provided text is a 510(k) Premarket Notification for the Faros Mobile device, and it does not contain a specific study proving the device meets acceptance criteria in the way typically associated with algorithmic performance (e.g., accuracy, sensitivity, specificity benchmarks).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CARDIO SPY ECG Holter Systems by LABTECH KFT.) and a reference device (eMotion Faros ECG Mobile by Mega Electronics Ltd.) through non-clinical testing and conformance to recognized voluntary standards.

Therefore, many of the requested items regarding acceptance criteria and performance studies for an algorithm's performance cannot be directly extracted from this document, as the submission primarily relies on the established safety and efficacy of the predicate device and standardized testing for hardware and software functionality.

However, I can extract information regarding the general acceptance criteria implied by regulatory standards and the types of testing performed to demonstrate substantial equivalence.

Here's a breakdown based on the provided text, addressing what can be answered and where information is not present:

Implied Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Conformance)

Since a direct algorithmic performance study with specific numerical acceptance criteria is not provided, the "acceptance criteria" here are inferred from the demonstrated conformance to regulatory standards and the equivalence to predicate devices. The device performance is generally stated as meeting these standards.

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

Information Not Present in the Document for Algorithmic Performance

The following points pertain to a specific study proving device meets acceptance criteria for algorithmic performance (e.g., accuracy in arrhythmia detection), which is not detailed in this 510(k) submission. The submission relies on "performance tests" that validate compliance with general safety and functional standards, rather than detailing a specific clinical or annotated dataset study for the algorithm's diagnostic accuracy.

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

• Not provided. The document states "ECG and algorithm performance tests" were done, but does not detail the dataset used for these tests, its size, or provenance.

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 provided. Ground truth establishment for a test set is not detailed. The interpretation algorithm's analysis "must be confirmed by a physician with other relevant clinical information," suggesting the algorithm is an aid, but no specific number or qualification of experts for validating the algorithm's performance is mentioned.

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

• Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study is not mentioned. The document states "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

• Not detailed. While "algorithm performance tests" are mentioned, detailed results or methodology for a standalone performance study (e.g., specific sensitivity/specificity values for arrhythmia detection on a labeled dataset) are not provided. The algorithm is presented as providing a "computer-generated analysis" that "must be confirmed by a physician," implying it's not intended for standalone diagnostic use.

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

• Not provided.

8. The sample size for the training set

• Not provided.

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

• Not provided.

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The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.

The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):

• · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
• · Evaluation of patients for ST segment changes
• Evaluation of patients with pacemakers
• · Reporting of time domain heart rate variability
• · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.)
• · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• Clinical and epidemiological research studies

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used.

The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable.

The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems.

The connection between the Holter and computer is performed by using Bluetooth and USB dongle.

The Cardiospy analysis software provides ECG records of excellent quality.

The provided text describes the Cardiospy ECG Holter System, its intended use, and its equivalence to predicate devices, but it does NOT contain an explicit study section with detailed acceptance criteria, reported performance, or specifics about a study design (like sample size, ground truth establishment, expert qualifications, or MRMC studies).

However, it does reference compliance with specific standards which contain performance requirements. I will extract the relevant information from those standards and the document's general claims to construct a response as best as possible.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested and found to fulfill the standard requirements. The most relevant standard for performance claims for an ambulatory ECG system with an analysis algorithm is AAMI / ANSI EC57:2012, "Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms." While the document doesn't explicitly list specific performance metrics from this standard as acceptance criteria, its inclusion implies compliance with the performance objectives outlined in EC57.

Since specific numerical acceptance criteria and reported performance values are not provided in the document, I will infer general performance aspects based on the device description and the standards it claims to meet.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Non-clinical testing of the product and its accessory proves that the following standard requirements are met" and "The test results prove that the device fulfills the standard requirements." It does not provide details of any clinical or non-clinical performance study data directly.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set. The standards like EC57:2012 typically involve a "reference truth" or "expert-annotated" datasets, but the submission itself doesn't detail their use.

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

The document does not provide information on any adjudication method used for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI/algorithm assistance. The device is described as an "ECG Holter System" with an "analysis algorithm" to "support the medical staff in analyzing and deciding the proper and adequate diagnosis," implying human-in-the-loop, but no comparative effectiveness study is presented.

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

The document implies a standalone analytical capability for the algorithm with features like "precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis." However, it explicitly states that the data and analysis "will be reviewed, confirmed, and used by trained medical personnel in the diagnosis." It does not provide specific standalone performance metrics or a study demonstrating algorithm-only performance. The compliance with EC57:2012 would typically require demonstrating algorithm performance, but the details are not in this document.

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

The document does not specify the type of ground truth used for performance evaluation. For devices complying with AAMI/ANSI EC57, ground truth is typically established through expert consensus or a "reference truth" dataset, but details are absent here.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size.

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

The document does not provide any information about a training set or how its ground truth was established.

Summary based on the provided document:

The submission largely relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards for safety and performance (IEC 60601 series, AAMI EC57, ISO 14971, etc.). It claims that the device was tested and fulfills these standard requirements, leading to the conclusion that differences do not raise new questions of safety and effectiveness. However, it does not provide the specific details of performance studies such as sample sizes, data provenance, expert ground-truthing, or comparative effectiveness. These details would typically be found in a separate study report or a more extensive section of the 510(k) submission, which is not included in this excerpt.

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The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

The CV3000 Holter Analysis System is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

The CV3000 Holter Analysis System is consisting of Holter recorder and the PC-based CV3000 Analysis Software.

The Holter recorder is an ambulatory electrocardiograph designed to be used with the PC-based CV3000 Analysis Software. It is intended to acquire, record and store up to 24 hours of ECG data from the patient. It performs no cardiac analysis by itself and is intended to be used with the CV3000 analysis software. ECG data prerecorded by the Holter recorder is analyzed by the CV3000 analysis software.

The provided text describes a 510(k) summary for the CV3000 Holter Analysis System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device's performance against such criteria.

The document focuses on demonstrating substantial equivalence (SE) to a predicate device (TLC5000 Holter Analysis System, K101273) through non-clinical tests that verify the device meets design specifications and complies with various safety and performance standards (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57).

The comparison table provided (Table 3-1) lists technical characteristics of the proposed device and the predicate device, emphasizing their similarities ("Same" or "Similar"). It also mentions that the proposed device "Have measurement function" which is "Same" as the predicate. This comparison is to support the claim of substantial equivalence, not to present a direct study demonstrating the proposed device's performance against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.

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The AUDICOR System when used with an AUDICOR Sensor on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, body position, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians.

The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the Hemo ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sounds, body position, sleep disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician.

The AUDICOR System analyzes and reports the following parameters:

• Heart rate including bradycardia and tachycardia events .
• Atrial fibrillation .
• ECG beat classification and morphology grouping with user-editing l
• . Heart rate variability
• Snoring detection .
• Sleep disordered breathing (apnealhypopnea) events
• . Sleep disordered breathing score
• Activity level .
• . Body position
• Heart sound and combined ECG/heart sound measurements .
• Heart rate distributions of heart sound parameters

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The AUDICOR System has two primary components for which clinical performance testing was conducted: "Body Position" and "Single Sensor Heart Sound."

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for either the Body Position or Single Sensor Heart Sound studies. Instead, it relies on demonstrating substantial equivalence to predicate devices.

Body Position:

Single Sensor Heart Sound:

2. Sample Size and Data Provenance

• Body Position: "a group of subjects representative of those intended to use the device." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but given the FDA submission, it's likely US-based or compliant with US standards.
• Single Sensor Heart Sound: "reemployed datasets initially used for obtaining FDA clearance for the two-sensor system on a group of patients representative of those the device is intended for." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but similar to the Body Position study, likely US-based.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number or qualifications of experts used to establish ground truth for either the Body Position or Single Sensor Heart Sound studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for establishing ground truth in the test sets.

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

No MRMC comparative effectiveness study is mentioned. The studies focus on device performance against a "gold standard" or a predicate device, not on how human readers improve with AI assistance.

6. Standalone (Algorithm Only) Performance

The studies described are standalone (algorithm only) performance evaluations.

• For Body Position, the AUDICOR "automated signal processing algorithm" processes accelerometer signals to determine body position, which is then compared to a "gold-standard performance."
• For Single Sensor Heart Sound, the "AUDICOR heart sound algorithms modified for use with a single sensor" are evaluated for their performance compared to the two-sensor system.

7. Type of Ground Truth Used

• Body Position: The document mentions "idealized gold-standard performance" for body position accuracy, but it doesn't specify how this gold standard was established (e.g., manual observation, another validated device, expert annotation). Given the reliance on accelerometer signals, it's likely a comparison to a highly accurate reference system for body position.
• Single Sensor Heart Sound: The ground truth for the comparison was the performance of the predicate two-sensor AUDICOR system. The study aimed to show "statistical equivalency" to this established system.

8. Sample Size for the Training Set

The document does not provide specific sample sizes for the training sets for either the Body Position algorithm or the Single Sensor Heart Sound algorithm. It mentions "retrospective clinical tests" were performed and "reemployed datasets" for the heart sound study, which implies existing data was used, potentially for training and/or testing.

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

The document does not explicitly describe how the ground truth for any training set was established. Given the retrospective nature of the studies and the comparison to a predicate device, it's plausible that the ground truth for training (if separate from testing) would have also been derived from established clinical data or the performance of the prior AUDICOR system.

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The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score.

Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic.

The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ●

The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. It primarily describes the device, its intended use, and states that it complies with certain standards. There is no information on sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of what could be extracted and what is missing, based on the input:

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

• Acceptance Criteria: Not explicitly stated in measurable terms (e.g., sensitivity, specificity thresholds). The document mentions compliance with standards (EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57) which likely contain performance requirements, but these are not detailed here. For the sleep disordered breathing analysis, it states it's intended "as a screening device...to determine the need for evaluation by polysomnography based on the patient's score," which implies a screening performance standard, but none is provided.
• Reported Device Performance: Not reported in quantitative terms (e.g., specific sensitivity, specificity, accuracy values for any of the detected parameters).

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: Not mentioned.
• Data Provenance: Not mentioned.

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)

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Adjudication Method: Not 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

• MRMC Study: Not mentioned. The document primarily focuses on the device's technical specifications and equivalency to predicates, not its impact on human reader performance.
• Effect Size: Not applicable as no MRMC study is reported.

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

• The document implies a standalone algorithm performance for features like sleep disordered breathing detection as it mentions "analysis and reporting" and "interpretation of the data in an integrated report for consideration by physicians," suggesting the algorithm generates an interpretation before physician review. However, specific performance metrics for this standalone functionality are not provided.

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

• Type of Ground Truth: Not explicitly stated. For sleep disordered breathing, it implies comparison to polysomnography ("screening device to determine the need for evaluation by polysomnography"), which would likely be the ground truth for that specific function, but this is not confirmed.

8. The sample size for the training set

• Sample Size: Not mentioned.

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

• Ground Truth Establishment: Not mentioned.

In summary, the provided text from the 510(k) K120462 document is a submission for a medical device modification (AUDICOR System - CPAM with SDB). It details the device's capabilities, intended use, and declares substantial equivalence to predicate devices, along with compliance with relevant safety and performance standards. However, it does not include the detailed study design, acceptance criteria, test set specifics, or performance metrics that would be necessary to populate the requested table and answer the study-related questions. Such information would typically be found in more detailed technical reports or clinical study summaries, which are not part of this "Summary of Safety and Effectiveness."

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