(193 days)
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
The provided text details the performance study of the Coala Heart Monitor, focusing on its ECG performance for detecting Normal Sinus Rhythm (NSR) and Atrial Fibrillation (AF).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported performance, as the study results are presented as demonstrating the device's capability. Explicit thresholds for acceptance criteria (e.g., "must achieve >X% sensitivity") are not directly stated but can be inferred from the high reported performance.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (AF Detection) | Reported Device Performance (NSR Detection) |
|---|---|---|---|
| Sensitivity | High (e.g., >90%) | 97.2% | 96.5% |
| Specificity | High (e.g., >85%) | 94.6% | 88.7% |
| Signal Quality & Accuracy | High | High | High |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1,000 ECG recordings.
- Patient Demographics: 150 patients (men, women, age 20-90, BMI30), described as "diverse."
- Data Provenance: Actual Coala users in Sweden. The data was collected "without any exclusions, training, control or influence, under a defined time period," indicating a retrospective collection from real-world usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One. The text states: "The same recordings were analyzed manually by a cardiologist as the gold standard."
- Qualifications of Experts: A "trained cardiologist." No further details on years of experience or specific board certifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: None. The ground truth was established by a single cardiologist. There is no mention of multiple readers or an adjudication process for discrepancies.
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 was done.
- The study focuses on the standalone performance of the device against a human expert (cardiologist), not on how human readers' performance is augmented by the AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The device's performance for detecting AF and NSR was compared directly to the cardiologist's interpretation of the ECGs.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus from a single cardiologist. The text explicitly states: "The same recordings were analyzed manually by a cardiologist as the gold standard."
8. The Sample Size for the Training Set
- The document does not specify the sample size for the training set. The study described focuses on the performance of the already trained device on a test set.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. It only details the method for establishing ground truth for the test set.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).