(260 days)
The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician.
Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport.
Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.
The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly.
The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.
The provided text does not contain detailed acceptance criteria and the results of a specific study to prove the device meets these criteria. Instead, it lists the standards and guidance documents used for design verification and validation, along with a high-level statement that testing demonstrates the device's safety and effectiveness compared to the predicate.
Therefore, many of the requested details cannot be extracted from the given information.
However, I can provide what is available, noting the limitations.
Missing Information:
- Specific quantitative acceptance criteria for device performance.
- The results of a specific study that quantitatively demonstrates the device meets acceptance criteria.
- Sample size used for a dedicated test set for performance evaluation (only general mention of "validation testing").
- Data provenance for any test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for any test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used for performance assessment.
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria and their corresponding reported performance values are not detailed in the document for HRV measurement accuracy or related metrics, this table cannot be populated as requested. The document primarily focuses on regulatory compliance through adherence to standards and safety/EMC testing, and a functional comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| (e.g., HRV measurement accuracy to within X bpm, etc.) | (e.g., Achieved Y bpm accuracy, etc.) |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-2-25 (Electrocardiographs specific requirements) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-1-6 (Usability) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 62366-1 (Usability engineering) | Testing was conducted and demonstrates compliance. |
| Compliance with ANSI/AAMI EC57 (Cardiac rhythm and ST-segment measurement algorithms) | Testing was conducted and demonstrates compliance. |
| Compliance with ANSI/AAMI EC53 (ECG trunk cables and patient leadwires) | Testing was conducted and demonstrates compliance. |
| Compliance with ASTM D4169-22 (Performance testing of shipping containers) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 62304 (Medical device software life-cycle processes) | Testing was conducted and demonstrates compliance. |
| Compliance with FDA Guidance: Content of Premarket Submissions for Device Software Functions | Adhered to the guidance. |
| Compliance with FDA Guidance: Cybersecurity in Medical Devices | Adhered to the guidance. |
| Design Validation against Product Requirements | Design Validation by Design Review was performed and successful. |
| Human Factors and Usability Engineering | Human Factors and Usability Engineering Report was generated and successful. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any performance-specific test set. The document refers generally to "Design validation testing" and "Design verification testing" but does not give sample sizes for subjects or data records.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- 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
- Not specified. The CloudHRV™ System calculates HRV indices and displays results, which are "used as an aid by clinicians." It does not appear to be an AI-assisted diagnostic or interpretation tool in the context of human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone algorithm performance for HRV calculation: "The raw cardiac electrical signals are detected...The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV." However, no specific performance metrics (e.g., accuracy, precision) are provided for just the algorithm, nor is a dedicated study described.
7. The type of ground truth used
- Not specified for the performance of the HRV calculation itself. The compliance testing for standards likely uses reference devices or simulated signals as ground truth for ECG parameters.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).