(122 days)
The BIOMONITOR III is indicated for use in:
· 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.
BIOMONITOR III is a programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.
The BIOMONITOR III is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III can be activated by the patient to record cardiac rhythm during symptomatic episodes. BIOMONITOR III may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors. The BIOMONITOR III is smaller than the predicate BioMonitor 2 while maintaining the same clinical functionality.
This 510(k) summary does not contain the detailed clinical study information typically found in a clinical trial report. It states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." Instead, it focuses on demonstrating substantial equivalence to a predicate device (BIOTRONIK BioMonitor 2, K152995) through non-clinical performance data and technological characteristics.
Therefore, many of the requested details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and ground truth for training sets cannot be extracted from this document because a clinical study of that nature was not provided.
However, based on the non-clinical data, we can infer some "acceptance criteria" through the validation testing described.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance data for specific arrhythmias are provided, the "acceptance criteria" are implied through the successful completion of the non-clinical tests demonstrating equivalence and safety.
| Acceptance Criteria (Implied from Non-Clinical Tests) | Reported Device Performance |
|---|---|
| No safety issues related to incision tool, insertion tool, or implant. | Successfully demonstrated no safety issues. |
| Equivalent QRS detection performance to the predicate device. | Demonstrated equivalent QRS detection performance between BIOMONITOR III and the predicate device over the implantation period. |
| User interfaces are safe and effective for intended users, uses, and environments (Usability/Human Factors). | Found to be safe and effective, conforming to IEC 62366-1. |
| Final device functionality (Validation and Verification Testing). | Thorough validation and verification testing performed and passed for: Particulate Matter Validation, Mechanical Verification and Validation, Electrical Verification and Validation, Biocompatibility, Sterilization Validation. |
| MRI compatibility at 1.5T and 3.0T. | Validation testing conducted according to ISO/TS 10974: 2018. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as a formal clinical study with a test set was not submitted. The "preclinical study" mentioned in section 7.1 would have involved a sample size (e.g., number of animals or in vitro samples), but these details are not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided as no clinical study with expert-adjudicated ground truth was submitted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided as no clinical study with expert adjudication was submitted.
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
An MRMC comparative effectiveness study was not done/not submitted. The device is an implantable monitor, and the focus is on its automated detection capabilities as substantially equivalent to a predicate device, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While not explicitly called a "standalone study", the document states that the device automatically records arrhythmias and that its "detection algorithms of BIOMONITOR III being unchanged from the predicate device." The validation testing (e.g., QRS detection performance) inherently evaluates the algorithm's performance in detecting these events without human intervention during the detection process. The statement that "BIOMONITOR III has the same part-rigid part-flexible design and the same overall shape as the predicate device (BioMonitor 2)" and that "BIOMONITOR III implant hardware-platform has been miniaturized with respect to BioMonitor 2" further suggests the focus is on hardware changes while maintaining the proven algoritihms of the previous device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "equivalent QRS detection performance" in the preclinical study, the ground truth would typically be established by a reference standard (e.g., human expert interpretation of ECGs, or another validated detection method) against which the device's QRS detection is compared. However, the exact nature of this ground truth is not detailed in this summary.
8. The sample size for the training set
This information is not applicable/not provided. The document states that the "detection algorithms of BIOMONITOR III being unchanged from the predicate device," implying that new training was not required for the algorithms themselves, or if training was done, it was for the predicate device and not detailed here.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons mentioned in point 8.
§ 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.