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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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