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The Horizon Angio is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature.

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

The Horizon Angio is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

The Horizon Angio software includes graphic presentation of the abdominal, cranial and peripheral vascular system, to support reporting of vascular catheterization.

The Sun Blade 150 workstation is a uni-processor system that runs the Cathlab program on a UNIX operating system. The workstation receives the digitized signals from the CFE via the Ethernet hub, displays real-time vital signs, analyzes, processes, and calculates the vital sign data and waveforms, cardiac status in real time during the catheterization process, creating a fully documented case history. The workstation continuously displays the vital signs waveforms and data on the local LCD displays.

The hemodynamic data, waveform and numerical, can be stored, analyzed and presented in a variety of report formats.

A Laser Printer is provided in the system. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

Base Configuration: Cathlab parameters

• . 2 Invasive Blood Pressure channels
• . Diagnostic 7 or 12 Lead ECG
• . Non-invasive Blood Pressure
• Pulse Oximetry (SpO2) .

Horizon Angio Options:

• Full Disclosure .
• Off-line workstations ●
• Remote Interactive terminal .
• . Angiography Analysis Package
• CDR, DVD or Optomagnetic drive .
• Choice of Console Table regular, enhanced, compact or without consol .

Here's an analysis of the provided text regarding the acceptance criteria and study proving device efficacy:

Device: Horizon Angio Cathlab (a sub-system of the Horizon 9000WS Cathlab)

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides extensive performance specifications for the Horizon Angio, which serve as the acceptance criteria. The accompanying information (e.g., "Meets or exceeds ANSI standard") indicates that the device's performance is intended to meet these criteria.

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

The document lacks explicit details regarding the sample size used for the test set in performance testing. It states: "Final testing for the whole Horizon Angio system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This implies internal testing rather than a clinical study with a specific patient test set.

The data provenance is not mentioned. Given the nature of a 510(k) submission for a device modification, the testing is likely retrospective on simulated or internal test data, not prospective clinical data from specific countries of origin.

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

The document does not mention the use of experts to establish a "ground truth" for a test set in the context of clinical performance. The testing described focuses on engineering and performance specifications against industry standards.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the testing focuses on meeting technical specifications rather than interpreting results that would require expert consensus.

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

No MRMC study is mentioned. This device is a physiological data acquisition and display system, not an AI diagnostic tool that assists human readers with interpretation. Therefore, a study comparing human reader improvement with or without AI assistance is not applicable to the information provided.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The "Final testing for the whole Horizon Angio system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications" implies standalone testing against its own specifications and relevant standards. The device is a "programmable diagnostic computer" that acquires and displays data, not an algorithm providing a diagnosis that would be independently evaluated for "algorithm-only" performance in a clinical context. Its performance is measured by the accuracy and reliability of its physiological measurements and display capabilities.

7. Type of Ground Truth Used:

The "ground truth" for the performance specifications are the defined electrical, physiological, and safety standards (e.g., ANSI/AAMI EC11, IEC 60601 series). For example, the accuracy of heart rate is measured against a known, controlled input signal, not against a clinical expert's interpretation or pathology.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as the Horizon Angio is not explicitly described as an AI/ML-driven device that learns from data. It's a system designed to acquire and display real-time physiological data based on pre-defined algorithms and hardware.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a training set or AI/ML components, the establishment of ground truth for a training set is not pertinent to this document.

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