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The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population.

The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices indicated for recording heart rhythm.

The Cardiologs Holter Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.

The Cardiologs Holter Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Holter Platform is not for use in life supporting or sustaining systems or ECG monitor and physiological alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs Holter Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns patient background, clinical history, symptoms, and other diagnostic information.

Cardiologs Holter Platform is comprised of:

• An interface, which provides tools to measure, analyze and review numerous ECGs;
• An automated proprietary ECG interpretation support algorithm using artificial intelligence (AI) to analyze ECGs to provide clinicians with supportive information for ECG diagnosis.

Cardiologs Holter Platform is an online portal that can be accessed through a network connection and allows the clinician to review and annotate the ECG signals. Alternatively, the Cardiologs Holter Platform can be accessed via an Application Programming Interface (API) connection. The API connection allows a digital ECG upload from a connected device and allows the connected device to receive the output of the Cardiologs ECG interpretation support algorithm and further process and display its output in their system.

Cardiologs Holter Platform is intended to analyze recordings from devices used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment of heart rhythm in adult and pediatric populations.

Cardiologs Holter Platform works in the following way:

1. Upload of a digital ECG file to Cardiologs' secure hosting databases;

   • i. Manual upload: via the web-interface
   • ii. Direct upload: no manual intervention required, upload occurs whenever the third-party hardware or software system is connected to the Cardiologs' Application Programming Interface (or API) and the ECG is automatically sent to the Cardiologs' servers.

2. Processing of the uploaded ECG file;

3. Analysis and annotation of the uploaded ECG performed by Cardiologs' proprietary algorithm;

4. Display the analysis of the ECG, along with the original signal, to the clinician for review of patient data. The algorithm output may be accessed/displayed through the following interfaces:

   • i. The clinician can access the algorithm output directly within Cardiologs using Cardiologs' user interface.
   • ii. The clinician can access the algorithm output in their own downstream system. The downstream system receives the output of the algorithm via Cardiologs' Application Programming Interface (API).
   • The Cardiologs Holter Platform allows for editing and/or validation of the measurements and parameters by the analyzing clinician.

5. A PDF report is generated as the result of the analysis.

The provided FDA 510(k) clearance letter for the Cardiologs Holter Platform (K250569) does not contain the detailed information required to describe the acceptance criteria and the specific study proving the device meets these criteria.

The letter states:

• "Performance testing demonstrates that the proposed device is as safe and effective and performs as well as the predicate." (Page 6 & 7)
• "No clinical testing was performed in support of this premarket notification." (Page 7)
• "The modified device includes performance updates to enhance the accuracy of the currently cleared abnormalities and measurements and expanded pediatric indications." (Page 6)

This indicates that internal performance testing was conducted, likely against the predicate device's performance, but the details of these tests (acceptance criteria, performance results, sample sizes, ground truth establishment, etc.) are not included in this public facing letter. Such information would typically be found in the full 510(k) submission document, which is not provided here.

Therefore, I cannot fulfill your request with the given input. The document is a clearance letter, which summarizes the outcome of the FDA's review, but does not detail the technical studies and their results.

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The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediation. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. The Cardiologs Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis.

The Cardiologs Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Cardiologs Holter Platform is a software only medical device with the following components made up of:

• An interface which provides tools to measure, analyze, and review numerous ECGs;
• An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.

Cardiologs Holter Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).

Cardiologs Holter Platform works in the following sequence:

• . Upload of digital ECG file to Cardiologs' secured hosting databases (for health data i.e. HIPAA compliant);
  • Manual upload: via the web-interface which allows the selection of files to upload on ● the evaluating user's computer
  • . Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the Cardiologs' Application Programming Interface (or API): the ECG is automatically sent to Cardiologs' servers.
• II. Processing of the uploaded ECG file;
• III. Analysis of the uploaded ECG performed by Cardiologs' proprietary algorithm, which labels the ECG:
  • . Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements "wave type/start time":
  • Abnormality labels: the algorithm provides probability scores on a predefined set of . abnormality labels (multi-label classification);
• IV. Cardiologs Holter Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the Cardiologs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine
• V. Cardiologs Holter Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.

The resulting information is stored on a secured database.

The provided text describes the Cardiologs Holter Platform (K212112) and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested.

It primarily focuses on the device's indications for use, a comparison of features with its predicate device, and a general statement about testing in compliance with recognized standards.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size, ground truth details, or comparative effectiveness study results from the provided text.

The closest information available is:

1. General Statement about Testing:

• "Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard."
• "All software validation testing was completed successfully and met all requirements."

2. Mention of Ground Truth (for clinical input requirements):

• "All clinical input requirements were validated against a gold standard." The specific type of "gold standard" is not elaborated.

3. No information regarding:

• A specific table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone performance (though it mentions the platform "can be accessed through a network connection/wireless device ... or locally (stand-alone algorithm)").
• Sample size for the training set.
• How ground truth for the training set was established.

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