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The Nuubo Smart is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The Nuubo Smart continuously records and stores ECG and activity data for up to 30 days at a time. The Nuubo Smart detects arrhythmias at the end of each monitoring day upon download of the ECG data. The Nuubo Smart is Rx use device.

Nuubo Smart is composed of the following main components:
Nuubo30 (wearable) - The Nuubo30 is the wearable box that contains one Nuubo30 textile unit, ECG conductive cream, patient instructions and washing bag. Each textile can be used for 30 days.
NuuboREC (recorder). The Nuubo recorder is a small, lightweight device that records ECG continuously. The device records 2 Leads of ECG data up to 30 days. The device also records data from a 3-axis accelerometer located inside the device. The patient can activate the button while wearing the product to mark a symptom. To start and stop the recording the user will press the on/off button. The data is stored into a micro SD memory card.
Nuubo Dock - The Nuubo Dock is the element for downloading the data from the NuuboREC and uploads that data to the Nuubo Cloud. It consists of a plastic stand with a smartphone attached to it and a microUSB port where the NuuboREC is connected for recharge and data download. The smartphone is a single-purpose device that is intended to be always connected to the dock. The dock is intended to be connected to an outlet in the patient's home with the charger provided. The dock allows to charge the NuuboREC device, and during this charging, it downloads the data from the NuuboREC device into the smartphone. The smartphone is software restricted and can only run the Nuubo Dock App that transmits and receives data from the Nuubo Cloud.
Leonardo Smart - Is used for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device. The new version Leonardo Smart allows a clinical professional previously authenticated in the platform, to download and review signals recorded by the NuuboREC device which have been uploaded using Nuubo Dock.

Here's a breakdown of the acceptance criteria and study information for the Nuubo Smart device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with harmonized standards. Direct, quantifiable acceptance criteria for arrhythmia detection performance are not explicitly stated for the new Nuubo Smart device in a separate table, but the performance of its underlying algorithm (inherited from Nuubo System K173461) is provided:

2. Sample Size Used for the Test Set and Data Provenance

The document mentions that the Nuubo Leonardo Arrhythmia detection algorithm (same as Nuubo System K173461) was tested against standard databases:

• MIT-BIH database: A widely recognized standard for arrhythmia analysis.
• AHA database: Another standard for arrhythmia analysis.

The exact sample sizes (number of recordings or patients) from these databases used for testing are not explicitly stated in this document. These databases are generally retrospective collections of ECG data. The country of origin of the data is not specified for these public databases, but they are international benchmarks.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the MIT-BIH and AHA databases. These databases typically have expert-annotated ground truth established by cardiologists or electrophysiologists as part of their creation.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method (e.g., 2+1, 3+1) used for the ground truth in the MIT-BIH and AHA databases. This information is usually part of the detailed documentation for those databases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not mentioned or described in the provided text. The evaluation focused on the standalone performance of the algorithm against standard ECG databases.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation was done for the arrhythmia detection algorithm. As stated: "The Nuubo Leonardo Arrhythmia detection algorithm (same as Nuubo System K173461) was tested per requirements of IEC60601-2-47, and showed a QRS Sensitivity and QRS Positive predictivity of over 99% against the MIT-BIH database, and over 97% against the AHA database."

7. Type of Ground Truth Used

The ground truth used for the standalone algorithm testing was based on expert-annotated arrhythmias within the MIT-BIH and AHA databases. These are widely used standard databases with established annotations.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the Nuubo Leonardo Arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. It only discusses the testing of the algorithm against public databases.

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