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The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.

The provided document describes the FDA 510(k) premarket notification for the Frontier X Plus device. It does not contain a specific table of acceptance criteria with reported device performance results, nor does it detail a multi-reader, multi-case (MRMC) comparative effectiveness study or provide effect sizes for human readers with AI assistance.

However, based on the Clinical Testing Summary section on pages 10-11, we can infer information about the study design that proves the device meets certain performance criteria.

Here's an attempt to structure the available information per your request:

Acceptance Criteria and Device Performance Study

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes a clinical investigation designed to demonstrate "substantial equivalence" to a predicate device, focusing on the ability of the device's algorithm to accurately detect and classify ECG rhythms.

Inferred Acceptance Criteria & Reported Device Performance (Qualitative)

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: A total of 832 users were included in the Study population for the clinical investigation.
   • Data Provenance: The document does not specify the country of origin for the data. It seems to be a prospective study as it describes the conduct of a clinical investigation where ECGs "were collected and analyzed at various time points."

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

   • The document implies that the ground truth for the rhythm analysis (Atrial Fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive, noisy/unreadable signals) was established by comparison to a "standard 12-lead ECG device."
   • It also states that the "reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience." This suggests that physicians (likely cardiologists or electrophysiologists) were the experts, but the number of experts and their specific qualifications (e.g., years of experience) are not explicitly stated for ground truth establishment within the study.

3. Adjudication Method for the Test Set:

   • The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set. It suggests that the 12-lead ECG served as the reference standard.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a MRMC comparative effectiveness study was not explicitly described or summarized in this document. The study focused on the device's (algorithm's) performance against a reference standard, not on how human readers' performance might improve with the device's assistance.

5. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone performance evaluation of the algorithm appears to have been a primary component of the clinical investigation. The study "evaluated the reliability of the Frontier X Plus ECG rhythm analysis software algorithm by assessing its ability to detect and classify Atrial fibrillation, Normal Sinus Rhythm, Tachycardia, Inconclusive and noisy/unreadable signals, from all the ECG recordings obtained on the subject device, when compared to simultaneously acquired signals from a standard 12-lead ECG device." This describes the algorithm's performance independent of human readers.

6. The Type of Ground Truth Used:

   • The primary ground truth used was simultaneously acquired signals from a standard 12-lead ECG device. This can be considered a form of clinical standard/reference data. The document also mentions that a "physician who will render a diagnosis based on clinical judgment and experience" reviews the reported information, implying physician interpretation as a ground truth for final diagnosis.

7. The Sample Size for the Training Set:

   • The document does not provide information on the sample size used for the training set of the algorithm. It only discusses the clinical investigation/test set.

8. 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, as it focuses on the validation study and not the algorithm development process.

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