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Horizon Cardiology ECG™ is a system for importing, storing, displaying and reviewing ECG procedures. Horizon Cardiology ECG is intended for use in the hospital environment by medical professionals.

HC ECG™ is a software application designed for use in various hospital departments, to import, display, store, analyze, distribute and process ECG procedures from resting ECG devices.

The HC ECG™ is intended to provide analysis or reanalysis of resting ECG's and to provide preliminary data for editing and confirmation by an over-reading physician. The HC ECG™ may provide a serial comparison of ECG data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.

HC ECG™ is a comprehensive ECG management system for importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management.

HC ECG™ functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs. HC ECG™ acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, HC ECG™ presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data.

The HC ECG™ graphic user interface provides tools that enable the physician to:

• edit measurements. .
• edit procedure diagnoses. .
• review numerous ECG procedures concurrently. .
• confirm ECG procedures. .
• distribute and print ECG procedure reports.

HC ECG™ complies with HL7 standards for export of reports to the Hospital Information System. HC ECG™ supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology ECG™ database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server.

Horizon Cardiology ECG ™ allows access to ECG records from web-enabled PCs throughout a network and enables authorized clinical users to access the system from remote locations.

The provided documentation is a 510(k) summary for the Horizon Cardiology ECG™ system. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a study that proves the device meets those criteria. Such detailed performance data and study results are typically found in the full 510(k) submission, which is not publicly available in this summary format.

Therefore, I cannot provide the requested information based solely on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical performance study with acceptance criteria.

To answer your request, if the information were available, here's how it would be structured and what details would be needed:

Acceptance Criteria and Device Performance Study (Information Not Found in Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: [Not provided in text]
• Data Provenance: [Not provided in text - e.g., "1000 ECGs from multiple hospitals across the US and Europe, collected retrospectively over 3 years"]

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: [Not provided in text]
• Qualifications: [Not provided in text - e.g., "Three board-certified cardiologists, each with over 15 years of experience in ECG interpretation"]

4. Adjudication Method for the Test Set

• Method: [Not provided in text - e.g., "2+1 adjudication, where if two experts agreed, that was the ground truth. If all three disagreed, they discussed and reached a consensus, or a fourth tie-breaking expert was consulted."]

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

• Was it done? [Not provided in text]
• Effect Size (if done): [Not provided in text - e.g., "Human readers improved diagnostic accuracy by an average of 5% with AI assistance compared to without."]

6. Standalone (Algorithm Only) Performance Study

• Was it done? The text mentions the system "utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison," suggesting standalone algorithmic performance. However, specific performance metrics for this standalone algorithm are not provided in the text.

7. Type of Ground Truth Used

• Type: [Not provided in text - e.g., "Expert Consensus" for ECG interpretations, "Pathology reports" for certain diagnoses, or "Outcomes data" for clinical relevance.] Given the nature of an ECG system, expert consensus by cardiologists is highly probable.

8. Sample Size for the Training Set

• Sample Size: [Not provided in text]

9. How Ground Truth for the Training Set Was Established

• Method: [Not provided in text - e.g., "Ground truth for the training set was established through expert consensus of two independent cardiologists, with a third cardiologist resolving discrepancies."]

In summary, the provided 510(k) summary (K061905) for Horizon Cardiology ECG™ serves as a regulatory document for market clearance based on substantial equivalence to existing devices. It does not include the detailed technical or clinical study results with acceptance criteria and specific performance metrics that would typically be part of a full regulatory submission or a scientific publication.

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