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The QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.

The QardioCore ECG monitor 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 QardioCore ECG ambulatory monitoring device is intended to capture, store, transmit, and display ECG information for recording periods of up to 24-hours in a single session. It is indicated for use on adult patients who may be asymptomatic or who meet clinical indications to perform an ECG-Holter monitor exam.

The QardioCore ECG monitor 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 QardioCore ECG Monitor is composed of six main components: i) the QardioCore sensor with Bluetooth technology, ii) a chest strap that allows fitting of OardioCore sensor, iii) a USB charging cable, iv) the Qardio App (can be downloaded and installed from the respective App store) and runs on any iOS device with iOS version 10.0 or later, v) the cloud based server where the Qardio App stores and retrieves data, and vi) the ECG Viewer which provides a web interface to the doctor to view the data sent by the iPhone application.

The QardioCore device is a wearable device that captures information through a single-channel ECG. The data is then encrypted and transmitted via Bluetooth Low Energy to the Qardio App, installed on a compatible mobile platform. The OardioCore is supplied with chest straps accommodating chest sizes ranging from 27-5 to 43 inches. An optional XL chest strap is available from 41.7 to 59.8 inches. The device is provided with a USB Type-A cable to charge the device.

The Qardio App (which can be installed from the user's respective app store), can transmit the data, via Wi-Fi or standard data mobile telephony, to Qardio cloud based server for storage processing and transmission to an expert medical professional.

The ECG Viewer application provides a web interface to the doctor to view the ECG data collected from the iPhone Application. All data that a patient accumulates using the QardioCore device is stored in the central server. The ECG Viewer provides the doctor with ECG data and Heart Rate (BPM), which a doctor can use as additional information for forming a medical diagnosis. The doctor is able to see both the ECG data and Heart Rate (BPM) as soon as the data becomes available in the central server provided that the patient accepts the doctor's request for access. The device does not include automated analysis except for heart rate calculation. QardioCore is not suitable for physicians who need to perform ECG diagnoses such as myocardial ischemia, left ventricular hypertrophy or specific bundle branch blocks that require multiple and precise electrode placement and consistent wave amplitude.

The provided text describes the QardioCore ECG ambulatory monitoring device and its substantial equivalence determination by the FDA. Here's a breakdown of the requested information, specifically focusing on the clinical testing to establish acceptance criteria and prove its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the purpose of the clinical study was to demonstrate the non-inferiority of the QardioCore ECG Monitor in terms of signal quality compared to a conventional, FDA-cleared, 3-channel ECG-Holter monitor device over a 24-hour recording time with continuous recording. While specific numerical acceptance criteria for "non-inferiority" are not listed, the general acceptance can be inferred from the conclusion that the device "demonstrated the substantial equivalence with the predicate device."

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "a population consistent with the device indications for use," but does not give a numerical count of participants in the clinical study.
• Data Provenance: The study was a prospective clinical study conducted to demonstrate the accuracy of the QardioCore. The country of origin of the data is not specified beyond the device being from a US-based company (San Francisco, California).

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The text mentions that ECGs from both devices "were collected and analyzed in a blinded fashion," implying expert review, but does not detail their numbers or qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The text mentions that ECGs "were collected and analyzed in a blinded fashion," which is a common practice in clinical studies, but gives no specifics on how disagreements among experts (if multiple were used) were resolved.

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

• This document describes a device for capturing, storing, transmitting, and displaying ECG information. It specifically states: "The device does not include automated analysis except for heart rate calculation." Therefore, a comparative effectiveness study involving human readers improving with AI assistance would not be applicable, as the device's primary function is data acquisition and display for physician review, not AI-driven interpretation.

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

• No, a standalone algorithm-only performance study was not done. The device's current functionality, as described, is for presenting data to a physician for review, with only heart rate calculation being automated. The "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience."

7. The Type of Ground Truth Used

• The ground truth was established by comparison with a reference device, specifically the ELA Medical, Inc., Spiderview Holter ECG recorder (K032466), which is an FDA-cleared 3-channel ECG-Holter monitor. The study aimed to demonstrate non-inferiority in signal quality against this established medical device.

8. The Sample Size for the Training Set

• Not applicable. The document describes a medical device for data acquisition and display, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would refer to the development and testing of the device's hardware and software according to recognized standards.

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

• Not applicable, as there is no mention of a machine learning training set for this device.

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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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SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or ﺴ
• other compatible cassette tape recorder. -
  In addition, any ISHNE compatible recording can be read by SyneScope™

EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727), or -
• other compatible cassette tape recorder. -

SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:

• SpiderView™ Holter ECG recorder (K032466), -
• SyneFlash™ Holter ECG (K990727) -

HolterReader is intended to view and print Holter reports from SyneScope™ p orts of TM and Comment The TW EasyScope™ and SyneCom™ .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:

• Patient symptoms such as syncope, dizziness or palpitations. .
• Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
• Function of an implanted pacemaker or defibrillator. .

SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).

SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.

The provided document is a 510(k) summary for ELA Medical's Holter ECG analysis software and related tools (SyneScope™, EasyScope™, SyneCom™, and HolterReader). It focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and a study to prove performance against those criteria.

Therefore, the information requested in your prompt regarding specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, and multi-reader multi-case studies is not present in this document.

The document does mention "functional testing" and "software verification and validation testing," but it defers the details to attachments (e.g., Attachment 10.6 for software verification and validation, Attachment 10.9 for safety and performance tests according to AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards, and Attachment 10.4 for field testing). Without these attachments, a complete answer to your request cannot be provided.

Based only on the provided text, here's what can be extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document mentions adherence to standards (AAMI/ANSI EC38:1998 & IEC 60601-2-47) and functional testing, but it does not present a table of specific quantitative acceptance criteria or device performance metrics against those criteria.

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

The document refers to "functional testing," "software verification and validation testing," and "field testing" but does not specify the sample size of any test set or the provenance of the data (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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 describes software for Holter ECG analysis and reporting, but it does not mention any MRMC comparative effectiveness study evaluating human reader improvement with or without AI assistance. This type of study is typically associated with AI-driven diagnostic aids. The device's description (Holter ECG analysis software) suggests it's an analysis tool, not necessarily an AI-assisted diagnostic system in the modern sense.

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

While the software performs automated analysis, the document emphasizes its use "under the supervision of licensed and trained practitioners." It does not present a standalone performance evaluation of the algorithm explicitly separate from human oversight. The "functional testing" and "software verification and validation" (references to attachments 10.6 and 10.9) likely cover the algorithm's performance, but the details are not included.

7. The type of ground truth used

The document refers to "functional testing" and "field validation," but it does not explicitly state the type of ground truth data used (e.g., expert consensus, pathology, outcomes data, etc.) for these evaluations. For Holter analysis, ground truth would typically come from expert cardiologist review of ECG recordings.

8. The sample size for the training set

The document does not mention a training set as this is a 510(k) for software functionality and equivalence, not explicitly for a machine learning or AI algorithm in the context of a "training set."

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

As no training set is mentioned, this information is not provided.

Summary of Studies Mentioned (without details):

The document states:

• SyneScope™, EasyScope™, SyneCom™ and HolterReader safety and performance testing: "Safety and performance tests according to the AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards." (Details in Attachment 10.9)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader software verification and validation testing: "Module and functional testing for SyneScope™, EasyScope™, SyneCom™ and HolterReader software applications." (Details in Attachment 10.6)
• SyneScope™, EasyScope™, SyneCom™ and HolterReader field testing: "Field validation protocol and evaluation form completion." (Details in Attachment 10.4)

In conclusion, while the document confirms that various tests were performed to demonstrate that the device performs in a safe and effective manner and complies with relevant standards, it does not provide the specific details of acceptance criteria, quantitative performance, sample sizes, ground truth establishment, or human-in-the-loop study results you requested. These details would likely be found in the referenced attachments.

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