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510(k) Data Aggregation
(141 days)
The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms.
The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.
The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers.
The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.
The LIVMOR Halo AF Detection System's acceptance criteria and the study proving it meets these criteria are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implicit from Predicate/Study Results) | Reported Device Performance (LIVMOR Halo AF Detection System) |
|---|---|---|
| Per Subject (n=92) | ||
| Sensitivity | Comparable to or better than FibriCheck (95.6%) | 100.0% |
| Specificity | Comparable to FibriCheck (96.55%) | 93.0% |
| Positive Predictive Value | Not explicitly stated as acceptance, but reported | 89.7% |
| Negative Predictive Value | Not explicitly stated as acceptance, but reported | 100.0% |
| Accuracy | Not explicitly stated as acceptance, but reported | 95.7% |
| Per Measurement (n=1834) | ||
| Sensitivity | Not explicitly stated as acceptance, but reported for predicate | 93.3% |
| Specificity | Not explicitly stated as acceptance, but reported for predicate | 99.1% |
Note: The document implicitly sets the predicate device's performance as a benchmark for substantial equivalence. While direct acceptance criteria are not explicitly listed in a "criteria" column, the demonstrated performance statistics are presented as meeting "performance goals."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Per Subject Analysis: 92 subjects.
- Per Measurement Analysis: 1834 measurements (derived from these subjects).
- Data Provenance: The document does not specify the country of origin. It indicates the data was collected through a "clinical study" involving "simultaneously collected ECG data with a Holter monitor," suggesting it was prospective in nature for the purpose of this validation study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document states that the ground truth was "established by physician review of simultaneously collected ECG data with a Holter monitor." It does not specify:
- The exact number of physicians (experts) involved.
- Their specific qualifications (e.g., years of experience, subspecialty).
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1 consensus). It only mentions "physician review."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a study to validate the standalone performance of the LIVMOR Halo AF Detection System against a ground truth established by physician-reviewed Holter ECGs. It does not mention a comparative effectiveness study involving human readers with and without AI assistance (i.e., an MRMC study to show human reader improvement).
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes. The study described is a standalone performance study. The device's algorithm generated results (AF detection), which were then compared directly against the ground truth established by physician review of Holter ECGs. The performance metrics (sensitivity, specificity, etc.) are reported for the device itself.
7. Type of Ground Truth Used
The ground truth used was "expert consensus" in the form of "physician review of simultaneously collected ECG data with a Holter monitor." This implies that the Holter ECGs provided the definitive physiological data, and physicians interpreted this data to determine the presence or absence of AF, serving as the gold standard for comparison.
8. Sample Size for the Training Set
The document does not provide information about the sample size of the training set used for the development of the LIVMOR Halo AF Detection System's algorithm. The provided data relates specifically to the validation/test set.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention the training set size, it also does not elaborate on how the ground truth for any potential training set was established. The clinical performance data provided solely pertains to the evaluation of the finished device on a test set.
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