(136 days)
The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias.
The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias.
The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
Here’s an analysis of the provided information regarding the BodyGuardian Remote Monitoring System, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state quantitative acceptance criteria or device performance in the typical format of sensitivity, specificity, accuracy, etc., for arrhythmia detection. Instead, it relies on a comparison to predicate devices and results of non-clinical bench testing.
Therefore, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various non-clinical tests, ensuring safety and effectiveness.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: The device should perform an equivalent function as the predicate devices in detecting and monitoring cardiac arrhythmias and transmitting health parameters. | The BodyGuardian System is stated to have the "same technological characteristics as the predicate devices in that all devices are intended to detect, transmit, and report digital data using similar computerized technology." It also has the "same intended uses as the predicate devices in that all devices are intended for ambulatory monitoring." |
| Electrical and Mechanical Safety Testing: The device must meet established safety standards. | EMC and electrical safety testing, electrical and mechanical safety testing, and system safety testing were conducted. |
| Software Verification and Validation: The software components must be verified and validated. | Software verification and validation were performed. |
| Performance Testing: The device's overall performance must be acceptable. | Performance testing was conducted. |
| Predicate Device Comparison Tests: Direct comparison testing against predicate devices. | Predicate device comparison tests were conducted. |
| Usability Testing: The device must be user-friendly and safe for its intended users. | Usability Testing was conducted. |
| Wireless Transmission Data Quality and Coexistence: The wireless communication must be reliable and not interfere with other devices. | Wireless transmission data quality and wireless coexistence testing were conducted. |
| Biocompatibility for Patient Contact Materials: Materials in contact with the patient must be biocompatible. | Biocompatibility testing for patient contact materials (Makrolon Versaflex) was performed. |
| Quality Assurance Measures: Development process must follow quality standards (e.g., FMEA). | Failure Mode Effects Analysis/Hazard Analysis (FMEA) and Design FMEAs for mechanical and RF designs were applied. Performance Requirements Testing including Final System Verification and Validation Testing, ISO 60601 Testing, 3rd Edition were completed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Testing: This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
Therefore, there was no clinical test set (and thus no sample size, data provenance) used to demonstrate the device's performance for arrhythmia detection in this submission. The evaluation was based solely on non-clinical (bench) testing and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set was used to establish ground truth for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 applicable. No clinical studies, including MRMC studies, were performed or required for this submission. The device is a "Remote Monitoring System" that collects and transmits data; it "does not provide any diagnosis." There is no mention of AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study for an algorithm related to arrhythmia detection. The device is described as a system that "detects and monitors cardiac arrhythmias" and collects data from "ECG sensors," but the validation focuses on the system's overall function and equivalence to predicates, not the independent performance of an arrhythmia detection algorithm against ground truth. Since it states the device "does not provide any diagnosis," it suggests the detection is a flag for healthcare professionals to review, rather than a diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical data or ground truth was established for performance evaluation in this submission. The ground truth for the non-clinical testing would have been defined by the test protocols (e.g., simulated signals for electrical safety, known material properties for biocompatibility).
8. The sample size for the training set
Not applicable, as no clinical data or machine learning models requiring a training set are described in this submission.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.