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VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.

The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

The VV330 Continuous ECG Platform is a single-channel, rechargeable, re-usable, ambulatory medical-grade continuous ECG recorder, intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home.

The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording systems intended for use on general care patients and on patients who are 18 years of age or older.

The VV330 Continuous ECG Platform is an ECG acquisition, storage, and transmission devices that utilizes disposable adhesive to maintain contact with the patient's skin and a hydrogel to promote electrical connectivity. The Platform has a re-usable sensor/recorder module allowing collection, storage and transfer of physiological data such as electrocardiogram (ECG), Accelerometer data, R-R Interval (RRI) and Heart Rate (HR). The Platform has a mobile data-display application built from a proprietary Software Library. And it also allows Authorized Persons to build their own applications using the same Software Library.

User's physiological are not transferred to healthcare professionals directly in any way; healthcare professionals can only view the data on the intended device (such as a mobile phone). User may view the physiological data in real time from the smart phone (or similar devices) while it records the data.

The Subject device provides operational alarms such as lead on/off status detection, battery monitoring, Over the Air (OTA) updates, real time clock, and power management. The operational alarms are intended to notify users of any interruption in data and of the overall operation status of the Recorder. The Subject device, being just a Transmitters and Receivers of Physiological Signal, does not provide any alarms based on physiological data setting.

The provided text describes the VV330 Continuous ECG Platform, but it does not contain the specific acceptance criteria or the details of a comparative study proving the device meets these criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria. While it lists recognized standards that the device conforms to, it does not explicitly state performance metrics or the methodology of studies used to prove these metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC study details or effect size of AI assistance.
6. Stand-alone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only provides the following relevant information:

• Device Name: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch.
• Intended Use/Indications for Use: Wireless recording system for record and display of physiological data (ECG, accelerometer, R-R Interval, heart rate) for healthcare professionals, intended for supplementary use on general care patients 18 years or older, at home or healthcare settings. Not for critical care, not to replace current standards of care.
• Performance Claim (Heart Rate Accuracy): 95% accuracy against true heart rate value under ambulatory conditions (this is a claim made in the comparison table, but no study details are provided to support it in terms of methodology or sample size).
• Standards Conformed To (listed in "Performance Data" section):
  • ISO14971:2007/(R)2010 (Risk Management)
  • ANSI AAMI ISO 10993-5:2009/(R)2014 (Cytotoxicity)
  • ISO 10993-10 Third Edition 2010-08-01 (Irritation and Skin Sensitization)
  • AAMI/ANSI EC-12:2000/(R)2012 (Disposable ECG electrodes)
  • ANSI AAMI ES60601-1:2005 (Third Edition) +CORR. 1:2006 + CORR. 2:2007+A1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 Edition 4.0 2014-02 (Electromagnetic disturbances)
  • IEC 60601-1-11:2015 Part 1-11 (Home healthcare environment requirements)
  • ANSI AAMI IEC 60601-2-47:2012 (Second Edition) (Ambulatory electrocardiographic systems)
  • ANSI IEEE C63.27-2017 (Wireless Coexistence)
  • IEC 62304: 2015 (Application of Usability Engineering to Medical Devices)

The "Performance Data" section merely states that "VivaLNK, Inc. ("VivaLNK") completed the appropriate design verification activities... through software, hardware, mechanical, biocompatibility, packaging tests, and electromagnetic compatibility testing." It confirms compliance with recognized standards but does not provide any specific study protocols, results, sample sizes, or ground truth establishment methods for demonstrating the device meets a set of performance acceptance criteria.

In the context of the prompt, the document lacks the detailed information typically found in a clinical study report or a more comprehensive validation test report.

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