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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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The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. 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 ECG Analysis 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 ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis 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 ECG Analysis 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 ECG Analysis Platform is 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 ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).

CardioLogs ECG Analysis Platform works in the following sequence:

• 1. 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.
• 2. Processing of the uploaded ECG file;
• 3. 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/ end time";
  • Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification);
• 4. CardioLogs ECG Analysis 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;
• 5. CardioLogs ECG Analysis 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 does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in a format that allows for the extraction of all requested data points. While it mentions performance evaluation and compliance with standards, and that "All clinical input requirements were validated against a gold standard," it does not specify the numerical acceptance criteria or the specifics of the study design, sample sizes, expert qualifications, or adjudication methods for that validation.

Therefore, I can only provide limited information based on the text.

Here's a summary of what can be extracted:

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

The document mentions that the device performs:

• Heart rate determination for non-paced adult
• QRS Detection
• Non-paced arrhythmia interpretation for adult patients
• Non-paced ventricular arrhythmia calls
• Intervals measurements
• Ventricular ectopic beat detection

It also states, "All clinical input requirements were validated against a gold standard," implying that the device's performance for these functionalities met certain (unspecified) acceptance criteria as compared to a gold standard. However, the specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and the reported device performance metrics are not provided in the text.

2. Sample sized used for the test set and the data provenance:

• Sample size for the test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The term "gold standard" is used without elaborating on how it was established or by whom.

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

• Adjudication method: Not specified.

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 an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as providing "supportive information for ECG analysis" and its "interpretation results are not intended to be the sole means of diagnosis," suggesting an assistive role, but no study details for this are given.

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

• The document describes the device as having "An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis." It also states, "CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician." This implies a standalone capability for analysis before physician review, but no specific study reporting standalone performance metrics is detailed.

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

• The text states, "All clinical input requirements were validated against a gold standard." The specific nature of this "gold standard" (e.g., expert consensus, pathology, follow-up outcomes) is not specified.

8. The sample size for the training set:

• Sample size for the training set: Not specified.

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

• How ground truth was established: Not specified, as details about the training set or its ground truth establishment are absent.

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