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The HiCardi+ H100 is intended to record symptomatic cardiac events and continuous electrocardiogram (ECG) for 72 hours from ambulatory patients by attaching HiCardi+ H100 SmartPatch to the skin surface. ECG records are stored in SmartPatch for review by the clinician after the recording period (up to 72 hours) is completed. It is indicated for use on 22 years or older who may be symptomatic and/or asymptomatic or suffer from transient symptoms as palpitations, shortness, of breath, dizziness, light-headedness, fatique, or anxiety. The reported ECG metrics include preliminary indications of the irreqular beat and/or rhythm and heart rate measurement based on a single-lead ECG basis. The arrhythmia information addressed in the report does not contain diagnostic interpretation; the reported indication is provided for review by the intended user to make a diagnosis based on clinical judgment and experience.

The HiCardi+ H100 consists of two components:

• . Patient-worn ECG patch (Sensor, SmartPatch);
• . Review & Report Generation Software (LiveStudio).

The SmartPatch is a wearable and reusable patch device intended to measure ECG signals from a patient for 72 hours. The SmartPatch is intended to record ECG signals and automatically indicate the irregular beat and/or rhythm of the recorded ECG data to aid the clinician in finalizing the ECG interpretation. The SmartPatch has an Event Button the patient can press to record symptoms, such as heart palpitations, dizziness, or chest pain, etc.

The LiveStudio is a review software operating on a personal computer (PC). The software visualizes the ECG data and preliminary indications from the SmartPatch for review, editing, and interpretation by the clinician. The LiveStudio provides tools to assist the clinician with their review. The final report includes the summary results of the review and can be documented by PDF formatted documents and printed by a printer connected to the PC.

The provided document details the FDA 510(k) clearance for the HiCardi+ H100 device. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service) through various performance data and compliance with standards. It lists various bench tests and clinical data to support substantial equivalence but does not provide details on specific acceptance criteria for a performance study of the arrhythmia detection algorithm or the results of such a study.

Here's a breakdown of what can be extracted and what is missing from your request based on the provided text:

Missing Information:

• A table of acceptance criteria and the reported device performance: This detailed table is not present. While standards are listed (e.g., IEC 60601-2-47, EC57 for validation of heart rate detection and arrhythmia detection algorithm), the specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) and their associated acceptance thresholds are not provided, nor are the actual numerical results for these metrics.
• Sample size used for the test set and the data provenance: Not specified for any performance evaluation directly comparing the device's algorithmic performance to a ground truth.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method: Not specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or detailed.
• Standalone (algorithm only without human-in-the-loop performance) study: While "Validation of heart rate detection and development of arrhythmia detection algorithm" is mentioned as a bench test, the specifics of this "validation" are not provided, including the study design, acceptance criteria, methods, or results of a standalone performance evaluation.
• Type of ground truth used: Not explicitly stated for performance validation studies.
• Sample size for the training set: Not specified.
• How the ground truth for the training set was established: Not specified.

What is mentioned that is relevant to performance data for substantial equivalence, but doesn't fully answer your questions:

• Performance Data: The document states that "Verification and validation activities established the safety and performance characteristics of the subject device with respect to the predicate."
• Bench Testing: Several bench tests were conducted, including:
  • "Validation of heart rate detection and development of arrhythmia detection algorithm (IEC 60601-2-47, EC57)"
  • "Disposable ECG electrodes Performance (ANSI/AAMI EC12)"
  • "Software Verification and Validation (IEC 62304)"
• Compliance to Standards: The device complies with various standards, including IEC 60601-2-47 (EC57), which is relevant to ambulatory ECG performance and includes requirements for heart rate detection and arrhythmia detection. However, the specific performance requirements within these standards and how the device met them numerically are not detailed here.

Conclusion based on provided text:

The provided document, an FDA 510(k) clearance letter and summary, confirms that the HiCardi+ H100 device received clearance based on substantial equivalence to a predicate device. It indicates that performance testing, including "Validation of heart rate detection and development of arrhythmia detection algorithm," was conducted in accordance with relevant standards (IEC 60601-2-47, EC57). However, the document does not provide the detailed acceptance criteria or the specific results of such a performance study (e.g., sensitivity, specificity, accuracy values) which would prove the device quantitatively meets those criteria. It notes that "Clinical data was reviewed to demonstrate the substantial equivalence of the subject device," but does not elaborate on the nature or results of this clinical review in terms of a performance study against specific acceptance criteria for its arrhythmia detection capability.

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