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The Liba3 ™ 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 Liba3™ 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.
  Liba3™ is intended to be used with adult patients 22 years and older, but not designed for pediative patients.

The Liba3™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of time. Each Sensor can be worn for up to 7.5 days. If the prescribed monitoring period exceeds 7.5 days. National Cardiac. Inc. will provide additional sensors. For a 30-day monitoring period, the patient would be required to use four (4) Sensor components. The Liba3 System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data.
The Liba3 system consists of: (1) a wearable electronic component that collects and monitors a patient's single lead ECG data referred to as a Liba3TM Sensor; (2) an optional transmitting device, referred to as the Liba3 transmitting device, that is used for ECG data transmission while the patient is wearing the sensor and for transmission of patient triggered events; 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.

I am sorry, but the provided text does not contain detailed information about the acceptance criteria for device performance and the specific study that proves the device meets those criteria, particularly in the context of an AI-powered medical device and the requested elements:

• A table of acceptance criteria and reported device performance: This is not present, nor are specific performance metrics related to AI algorithm accuracy provided. The document focuses on regulatory compliance and substantial equivalence to a predicate device.
• Sample size and data provenance for the test set: There is no mention of a test set, its size, or the origin of the data.
• Number and qualifications of experts for ground truth: No information is provided about expert involvement in establishing ground truth for a test set.
• Adjudication method: Not discussed.
• MRMC comparative effectiveness study: There is no mention of a multi-reader multi-case study or the effect size of AI assistance on human readers. The document primarily concerns the device as an ambulatory cardiac monitoring system, not specifically an AI-assisted diagnostic tool in the typical sense of imaging AI.
• Standalone algorithm performance: While the device has an "Arrythmia detection algorithm (Proprietary / Server side)", there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) provided for this algorithm in a standalone capacity.
• Type of ground truth: Not specified for any performance evaluation.
• Sample size for training set: No information is provided about a training set or its size.
• How ground truth for training set was established: Not discussed.

The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device (NowCardio™ System). It highlights technological characteristics, compliance with various medical device standards (e.g., electrical safety, biocompatibility, risk management, software life cycle), and general design verification activities. However, it does not provide the specific performance study details, acceptance criteria, and ground truth methodologies typically expected for a detailed AI device performance evaluation.

The closest relevant statement is under "G. Non-Clinical Performance Data," which mentions "complete design verification activities which included verification of all design input requirements and ECG Analysis performance vs. recognized Databases, ECG analysis software validation". However, it does not elaborate on what these "recognized Databases" are, the specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection), the acceptance criteria for these metrics, or the methodologies used to establish ground truth within those databases.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study as outlined in your prompt based on the provided text.

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