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The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

The Mdoloris Medical Systems SAS (Mdoloris) HFVI Monitor is a heart rate variability monitor intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The HFVI Sensor acquires electrocardiographic (ECG) signals from the patient, and the Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI). The HFVI is a measure of heart rate variability (HRV), and has a value between 0 and 100. It is intended for use on adult and pediatric patients.

The provided document is a 510(k) summary for the Mdoloris HFVI Monitor. It outlines the device's indications for use, its technological comparison to a predicate device, and a summary of performance testing related to software, electrical safety, electromagnetic compatibility, and bench performance.

However, the document does not contain specific acceptance criteria, a detailed study design, or reported device performance metrics in the way typically expected for a clinical study proving a device meets acceptance criteria for diagnostic efficacy or accuracy. The performance testing summary primarily focuses on compliance with general safety and engineering standards (e.g., IEC, AAMI) and internal requirements, rather than a clinical validation of the HFVI measurement against a gold standard or a comparison of its diagnostic performance.

Therefore, many of the requested details cannot be extracted from this document, particularly those related to clinical accuracy, sample sizes for test/training sets, expert involvement, and ground truth establishment for clinical performance.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information Regarding Clinical Performance or Diagnostic Accuracy:

• Specific numerical acceptance criteria for the accuracy of HFVI measurement itself (e.g., "HFVI measurement shall be within X% of a gold standard").
• Reported accuracy, sensitivity, specificity, or other performance metrics for the HFVI values.
• Clinical validation study results comparing the HFVI monitor's output to any reference method or clinical outcome.

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

• Sample Size (Test Set): Not specified for clinical or performance evaluation beyond compliance and engineering standards. The document only mentions "test results" for software validation, electrical safety, EMC, and bench performance without detailing sample sizes of patients or data points.
• Data Provenance: Not specified. The document primarily refers to engineering and software testing, not clinical data from patients.

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

• This information is not provided. The document does not describe any clinical test set where experts would establish ground truth for a diagnostic or prognostic performance claim. The device measures HRV, and states "These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician." This implies a lack of a direct diagnostic claim that would necessitate expert-established ground truth in a clinical validation study.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set requiring adjudication by experts is described in the provided 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

• No MRMC comparative effectiveness study is mentioned. The device is a monitor that provides a physiological parameter (HFVI), not an AI-assisted diagnostic tool for interpretation by human readers.

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

• The document implies standalone performance validation for the general operation of the device and its algorithm in the context of engineering and software testing. The "Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI)." However, the specifics of how the algorithm's accuracy in calculating HFVI was verified against a known gold standard for HRV measurement are not detailed. The provided studies revolve around compliance with basic safety and engineering standards rather than the accuracy of the HFVI calculation itself.

7. The Type of Ground Truth Used

• For the engineering and safety tests, the "ground truth" was compliance with established industry standards (IEC, AAMI) and the device's own predetermined internal specifications.
• For the HFVI measurement itself, the document does not specify a separate "ground truth" or a direct validation study against a gold standard for HRV measurements. The comparison is primarily in terms of technological characteristics and overall safety/effectiveness relative to a predicate device, rather than absolute accuracy of the HFVI value against a definitive reference.

8. The Sample Size for the Training Set

• Not applicable/Not provided. The document focuses on performance testing for regulatory clearance, not on details of algorithm development or training data.

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

• Not applicable/Not provided, as details about a training set for an algorithm are not included in this regulatory submission summary.

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