(99 days)
The BioMonitor is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
- The device has not been tested for and it is not intended for pediatric use
The BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradyarrhythmia, asystole, or high ventricular rate. The device memory can store up to 13.3 min of ECG recordings from automatically detected arrhythmias and up to 22.5 min of ECG recordings from patienttriggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor. The BioMonitor is intended to aid in the diagnosis of cardiac arrhythmias in patients that may otherwise qo undetected.
The provided text describes a 510(k) premarket notification for the BioMonitor, an implantable cardiac monitor with AF detection. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The main performance metrics reported are for Atrial Fibrillation (AF) detection. The text does not explicitly state pre-defined acceptance criteria values (e.g., "Sensitivity must be > 90%"). Instead, it presents the results of the clinical study as the device's performance.
| Performance Metric | Reported Device Performance (Mean ± SD) |
|---|---|
| AF Episode Sensitivity | 94% ± 14.7% |
| AF Episode Positive Predictive Value (PPV) | 73.7% ± 40.3% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 50 participants. Of these, 27 showed at least one true AF episode.
- Data Provenance: Single-center, prospective, nonrandomized study. The text does not specify the country of origin, but given the manufacturer is BIOTRONIK SE & Co. KG (Germany) and the sponsor is BIOTRONIK, Inc. (USA), it's likely a study conducted in either the US or Europe, or both. The data is prospective as participants were equipped with both devices and monitored.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The text mentions "expert-annotated, external Holter ECG recorder." It implies an expert (or team of experts) reviewed the Holter data, but the exact number isn't provided.
- Qualifications of Experts: Not explicitly stated. The term "expert" implies a qualified medical professional, likely a cardiologist or electrophysiologist, experienced in interpreting ECGs and diagnosing cardiac arrhythmias.
4. Adjudication Method for the Test Set
The text states that the ground truth was established by "expert-annotated, external Holter ECG recorder." It does not provide details on an adjudication method (e.g., 2+1, 3+1, none) among multiple experts, suggesting either a single expert annotation or a process that doesn't involve explicit adjudication steps among several.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed to compare human readers with and without AI assistance. The study described focuses on the standalone performance of the BioMonitor against an expert-annotated Holter ECG as the gold standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The clinical study aimed to "evaluate BioMonitor AF detection performance... in comparison with the gold standard, expert-annotated, external Holter ECG recorder." This demonstrates the algorithm's performance without direct human intervention in the detection process based on the BioMonitor's automated output.
7. The Type of Ground Truth Used
The ground truth used was expert consensus / expert annotation based on an external Holter ECG recorder. The text explicitly states: "The ability of BioMonitor to detect episodes of AF was quantified in comparison with the gold standard, expert-annotated, external Holter ECG recorder."
8. The Sample Size for the Training Set
The document does not provide information about the sample size used for the training set for the BioMonitor's AF detection algorithm. The clinical study described is a validation study, assessing the performance of the already developed device.
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 validation study and its ground truth establishment.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.