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The HORIZON 9000 WS (Cathlab) 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 Cathlab is 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 Cathlab runs on a UNIX/Sun Solaris* operating system on a SUN® computer that utilizes spowerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

This document describes a Special 510(k) for a device modification of the Horizon 9000WS Cathlab, specifically replacing the Patient Front End (PFE) with a Cathlab Front End (CFE). The submission aims to demonstrate that the modified device is substantially equivalent to the predicate device.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as "acceptance criteria" but are embedded within the product specifications for the Cathlab Front End (CFE). The device performance is reported as meeting these specifications.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of image-based AI or diagnostic algorithm evaluation. Instead, it states that "The Cathlab with the CFE has been subject to extensive safety and performance testing to ensure that the signals/waveforms sent by the CFE to the Cathlab have the same characteristics as those sent by the PFE to the Cathlab." This implies a comparative testing approach rather than a traditional test set for an algorithm.

The data provenance is not explicitly detailed. It can be inferred that the testing was performed by "Mennen Medical Ltd." (Israel) and an "independent testing laboratory" for electrical safety and EMC. There's no mention of country of origin of data in terms of patient population or images, as this is a physiological monitoring device rather than an imaging or diagnostic device. The testing describes the performance characteristics of the hardware and software, not historical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physiological monitor, not an AI or imaging diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here is adherence to technical specifications and industry standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there is no specific "test set" for diagnostic accuracy with human-expert adjudication in this context. The adjudication method for meeting technical standards would typically involve verification by qualified engineers/testers against established metrics.

5. 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

Not applicable. This document pertains to a hardware modification for a physiological monitoring device and does not involve AI for interpretation or improvement of human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physiological monitor; its performance is described in terms of its ability to acquire and display patient data, not as a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device modification is based on technical specifications, industry standards (e.g., ANSI/AAMI, IEC), and the performance characteristics of the predicate device (Horizon 9000WS Cathlab with PFE). The goal was to ensure the modified CFE matched or exceeded the performance of the existing PFE.

8. The sample size for the training set

Not applicable. This document describes a hardware device modification, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model described.

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