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The Now Cardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:

• · Atrial Fibrillation
• · Bradycardia
• Tachycardia
• · Pause

It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Now Cardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting.

Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

The NowCardio™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of up to 32 days. The NowCardio System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The NowCardio™ system consists of: (1) a wearable electronic component that collects and monitors a patient's ECG data referred to as a NowCardio™ Sensor; (2) a custom cradle, referred to as the NowCardio™ Cradle, that is used to configure/charge the NowCardio™ Sensor in addition to providing ECG data download capability; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.

The provided document, K162956, is a 510(k) premarket notification letter for the NowCardio™ System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a detailed clinical or performance study with a test set. This type of submission relies heavily on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, the document does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a test set, nor does it detail a study proving the device meets such criteria in terms of algorithm-specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) as would be derived from a clinical validation study.

The document states:

• "Similar performance testing has been conducted on the NowCardio™ System and its predicates. There are no substantial differences in performance testing of the devices. Therefore, the NowCardio™ System is determined to be substantially equivalent to the predicate devices." (Page 5, Section VI)
• Under "VII. PERFORMANCE DATA", it lists various nonclinical tests, primarily focusing on general device safety, electrical performance, software validation, and compliance with standards like IEC 60601-1, IEC 60601-2-47, ISO 14971, and IEC 62304. These are engineering and regulatory compliance tests, not performance studies of the arrhythmia detection algorithm.

Given this, I cannot extract the requested information regarding algorithm performance, acceptance criteria for those metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or training set details from this 510(k) summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a 510(k) submission based on substantial equivalence and non-clinical testing, not a detailed clinical performance study proving specific algorithm-driven acceptance criteria.

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