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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 HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, whose prime function is the acquisition and display of vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. 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 system has a UNIX Sun Solaris 2 (Ultra 5 computer) that utilizes powerful, 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 print-outs of textual and graphical summaries of all patient data and catheterization procedures.

This document is a 510(k) summary for the Mennen Medical LTD. Horizon 9000 WS Computerized Catheterization Laboratory. It describes the device's function and its substantial equivalence to a previously cleared device. However, this document does not contain information about specific acceptance criteria or study results demonstrating that the device meets such criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The provided text is a regulatory submission for premarket notification (510(k)). Its primary purpose is to establish substantial equivalence to a predicate device, not to detail specific performance studies with acceptance criteria. It states that "None promulgated" for Performance Standards, indicating that the FDA had not issued specific performance standards for this type of device at that time.
• Focus on Substantial Equivalence: The document highlights the device's capabilities and compares them to a predicate device (Horizon 9000 WS - K 940415) cleared in 1995. The FDA's letter (Page 6) confirms that they "reviewed your Section 510(k) notification... and have determined the device is substantially equivalent." This means the device is considered as safe and effective as a legally marketed predicate device, primarily based on its specifications and intended use, not necessarily independent performance studies against defined acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details because that information is not present within the provided text.

To answer your questions, the following information would typically be found in a detailed device validation study report, which is usually part of a more extensive submission, but not always summarized in the publicly available 510(k) summary:

1. A table of acceptance criteria and the reported device performance: Would need specific performance claims (e.g., accuracy of heart rate measurement within X BPM, blood pressure measurement within Y mmHg) and the results of tests demonstrating these.
2. Sample size used for the test set and the data provenance: Would need details on how many patients or data points were used for testing, and if the data was collected prospectively, retrospectively, or from specific geographies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a device primarily measuring physiological parameters. Ground truth for parameters like heart rate or blood pressure would come from other validated measurement devices, not expert consensus interpretation.
4. Adjudication method: Not applicable for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Highly unlikely for a a data acquisition and display system. MRMC studies are typical for image interpretation devices where human readers interpret medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone system for data acquisition and display. Its performance would be evaluated on its ability to accurately acquire and display physiological data.
7. The type of ground truth used: For physiological measurements, ground truth would typically be established by simultaneously using a highly accurate, reference standard measurement device (e.g., highly calibrated pressure transducers for blood pressure, gold-standard ECG machines for heart rate).
8. The sample size for the training set: Not applicable for this type of device. Training sets are relevant for AI/ML algorithms that learn from data. This device is described as a "computerized laboratory" using "real-time software to control the system operation and to process the vital patient sign data measurements," implying programmed functionality, not machine learning.
9. How the ground truth for the training set was established: Not applicable for this type of device.

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