(113 days)
The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time:
• ECG
• Heart rate (including HR variability and HR reliability)
• Respiration rate
• Activity
The BodyGuardian System is an ambulatory cardiac monitoring system prescribed by healthcare providers. It monitors and records a patient's electrocardiographic (ECG) data, heart rate, respiration rate and activity level. The complete system consists of components that collect data, send the data to a remote Preventice computer server, store the data in secure databases, and present the data for review by healthcare professionals.
The provided documentation presents a 510(k) summary for the BodyGuardian System. While it lists non-clinical testing performed, it explicitly states "Clinical Testing: Not applicable." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria based on clinical performance.
However, based on the provided text, here's what can be extracted regarding the device and its testing:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) as no clinical testing was deemed applicable.
However, the "Non-Clinical Testing" section implies performance was evaluated against internal benchmarks or standards during the following:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from non-clinical testing) |
|---|---|
| Compliance with EMC and electrical safety standards | Passed EMC and electrical safety testing |
| Accurate ECG performance | ECG performance testing conducted |
| Accurate activity level measurement | Activity level measurement validated |
| Accurate respiration rate measurement | Respiration rate measurement validated |
| Software functions correctly and reliably | Software verification and validation completed |
| Biocompatibility of materials | Biocompatibility testing conducted |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was used for performance evaluation according to the document. The non-clinical testing would have used internal test samples, but details on their size or provenance are not provided.
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)
Not applicable, as no clinical test set with expert-established ground truth was used for performance evaluation.
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. The document states "Clinical Testing: Not applicable," which means no MRMC study, human-in-the-loop performance, or AI assistance was evaluated in a clinical context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone testing of components like "ECG performance," "Activity level measurement," and "Respiration rate measurement" during non-clinical testing. However, this is not a comprehensive "standalone" evaluation of the arrhythmia detection algorithm in a clinical context, as clinical testing was not applicable. Details of these individual test methodologies and results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the ground truth would have been established through controlled electrical signals, mechanical simulations, reference devices, or chemical analysis, depending on the specific test (e.g., calibrated ECG simulators for ECG performance, known activity levels for activity validation). However, the document does not specify these details.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI/ML algorithm that would require a training set in the context of clinical performance. The "software verification and validation" would have involved internal testing against coding standards and functional requirements, but not a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as no training set (for AI/ML algorithm) is mentioned or implied.
§ 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.