(65 days)
The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients:
- with fluid management problems .
- taking diuretic medication .
- living with heart failure .
- living with end-stage renal disease .
- suffering from recurrent dehydration .
- who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but . not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The AVIVO Mobile Patient Management System also monitors, derives and displays:
- ECG .
- Heart Rate (including HR variability) .
- . Activity
- . Posture
- Respiration rate (including RR variability)
- Body fluid status
The AVIVO System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days for each PiiX application.
The AVIVO system components are:
- . PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data.
- . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
- Server The Server receives sensor data from the PiiX via zLink. ECG, heart . rate and other physiological parameters are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians
The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.
This submission is for an abbreviated 510(k) for the AVIVO® Mobile Patient Management System. The purpose of this submission is to add clarifying language to the indications for use, aligning it with language used in a predicate device (NUVANT) for non-lethal arrhythmias and with another predicate device (ZOE) for fluid status measurements. The manufacturer states that these changes are for clarification and do not alter the intended use, safety, or effectiveness of the device. Consequently, the performance testing details provided focus on compliance with recognized medical device standards rather than a study demonstrating new device performance against acceptance criteria for specific clinical outcomes or algorithm accuracy.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity for arrhythmia detection or fluid status accuracy) and corresponding reported performance from a dedicated clinical study for the subject device. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established performance standards for medical electrical equipment.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 | The subject AVIVO and predicate devices meet these requirements. |
| IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) | The subject AVIVO and predicate devices meet these requirements. |
| AAMI/ANSI EC38: Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 2007. | Not explicitly stated that the subject device underwent separate testing against this, but it is implied it meets these requirements by being substantially equivalent to predicates that do. The document states "The subject and predicate AVIVO and predicate NUVANT meet the requirements of following performance standards..." |
| AAMI/ANSI EC57: Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms, 1998/(R) 2008 | Not explicitly stated that the subject device underwent separate testing against this, but it is implied it meets these requirements by being substantially equivalent to predicates that do. The document states "The subject and predicate AVIVO and predicate NUVANT meet the requirements of following performance standards..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "bench tests" (Section 4, "SUMMARY OF PERFORMACE TESTING" and Section 4, "CONCLUSION") but does not provide details on sample sizes for any test sets related to specific clinical performance. The focus is on meeting general safety and performance standards for existing medical devices, rather than a clinical study with a patient test set for the device's diagnostic or monitoring accuracy. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical test set and associated ground truth establishment process are described for the subject device in this submission, as the submission relies on substantial equivalence and adherence to general performance standards mentioned in Section 4.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is described in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size for human reader improvement. The device described transmits physiological data to "learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians." This implies human interpretation as part of the overall system, but not a comparative effectiveness study of AI assistance.
6. Standalone (Algorithm Only) Performance:
Not explicitly detailed as a separate study for the subject device. The device is part of a system that includes human interpretation ("learned intermediaries"). While the device's algorithms for parameters like heart rate and respiration rate would operate in a standalone manner within the device, a dedicated "standalone performance" study comparing its algorithmic output to a ground truth (independent of human interpretation) is not presented in this document as a part of the evidence for this 510(k) submission. The performance is tied to the overall system's ability to "continuously record, store, and periodically transmit physiological data" and meet general device standards.
7. Type of Ground Truth Used:
For the performance testing mentioned (compliance with standards), the ground truth would be the defined specifications and measurement methodologies within those standards (e.g., standard signal inputs for ECG accuracy tests as per AAMI/ANSI EC38/EC57). There is no mention of a clinical ground truth (e.g., pathology, outcomes data, or expert consensus from patient data) specifically generated for this 510(k) submission.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development or training of a specific artificial intelligence or machine learning algorithm that would require a dedicated training set. The device is being submitted as an updated version of an existing device (predicate AVIVO), with clarifications to its indications for use, and its performance relies on established engineering principles and adherence to recognized standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for an AI/ML algorithm is described.
§ 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.