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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures, and EtCO2.

BP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and FFR, can be stored, recorded, analyzed and presented in a variety of report formats.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display. The Central System contains the following main devices: Computer, Two local LCD displays, Video line driver, AC Power Unit, Laser printer, Hub, Modem. FFR is a mode that uses two invasive pressure inputs. Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed.

The provided document describes the Mennen Medical Horizon XVu with the addition of Fractional Flow Reserve (FFR) measurement, submitted as a traditional 510(k) for device modification (K123792).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table between the predicate device (Volcano ComboMap) and the modified Horizon XVu with FFR, particularly focusing on input circuit parameters and measurement capabilities. While it doesn't explicitly state "acceptance criteria" as a pass/fail threshold, it presents a comparison of specifications.

Note: The document emphasizes that "the basic amplifier specifications are the same for the Horizon XVu (FDA approved) and the Horizon XVu with FFR." The key "reported device performance" is that the Horizon XVu with FFR can successfully display the FFR waveform and value, and its FFR measurement capabilities are comparable to the predicate. The provided table details the technical specifications that are meant to show this comparability and thus meet the implicit acceptance criteria of substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

The document states: "At the system level, SW Validation of the performance of the Horizon XVu with 9600PT580/585 as compared to the Horizon XVu Cathlab system, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Horizon XVu."

It also mentions: "Final testing for the Horizon XVu system included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Horizon XVu system."

• Sample Size for Test Set: The document does not specify a sample size for the test set. It refers generally to "system level, SW Validation" and "Final Testing" without providing numbers of test cases, patients, or data points.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. The validation and testing appear to be internal to Mennen Medical, conducted as part of their software and system validation process.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth. The testing mentioned appears to be focused on technical performance and comparison to specifications rather than clinical ground truth established by external experts.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The validation seems to rely on internal test plans and procedures, likely against predefined technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The submission is for a device modification (addition of FFR measurement capability) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, not on human-in-the-loop performance metrics or improvements with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing described appears to be standalone in nature, focusing on the system's ability to acquire, process, calculate, and display FFR and other vital signs according to its specifications, without explicitly evaluating human interaction or diagnostic decisions. The FFR calculation itself is an algorithm. However, no specific "algorithm only" performance metrics (e.g., sensitivity, specificity, AUC) are provided for the FFR calculation; rather, it focuses on the accuracy of the underlying pressure measurements. The "Measurement accuracy" for FFR is specified for the pressure measurements: "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This is a standalone performance metric for the pressure measurement component of the FFR calculation.

7. The Type of Ground Truth Used

The ground truth used for the device's FFR capability is based on the accuracy of pressure measurements and the ratio calculation (Pd/Pa) as compared to predefined technical specifications. The document states a measurement accuracy of "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This implies that the ground truth for evaluation is derived from calibrated pressure inputs and the expected mathematical outcome of the FFR ratio. It is a technical ground truth rather than a clinical one established by pathology or patient outcomes.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a "programmable diagnostic computer" with added FFR measurement, not an AI/ML-based device that typically undergoes a training phase with a distinct training set. The FFR calculation is based on established physiological principles and algorithms, not learned from data in the way AI models are trained.

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

Since there is no mention of a training set for an AI/ML model, there is no discussion of how ground truth for a training set was established. The FFR calculation is a deterministic algorithm based on real-time pressure measurements.

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.

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 prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The Horizon XVu system consists of a Front End unit (CFE) and a Central system. The CFE acquires, processes, and converts vital signs from the patient into digital signals and sends them to the central system for process and display. The central system contains a computer workstation, displays, printer, and other components. The system is capable of acquiring and displaying ECG/Heart Rate, ICECG, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature.

The provided text describes a 510(k) submission for a modification to the Mennen Medical Horizon XVu device, specifically adding an Intra-Cardiac ECG (ICECG) measurement option. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new clinical effectiveness. Therefore, some of the requested information, particularly related to clinical study design (sample size, expert ground truth, adjudication, MRMC studies) for new effectiveness claims, is not detailed in this type of regulatory document.

However, based on the provided text, we can extract information regarding acceptance criteria (implied by the comparison to a predicate device) and the verification/validation activities performed.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified Horizon XVu with ICECG (960-OPT-600) are implicitly defined by its substantial equivalence to two predicate devices:

1. Horizon XVu (K081484): For the overall Cathlab system functionality, ensuring that the addition of ICECG does not negatively impact existing vital sign acquisition and display.
2. Mennen Medical EMS-XL cardiac electrophysiology system (K071348): Specifically for the ICECG measurement capabilities, ensuring its performance is comparable to the ICECG functionality of the EMS-XL.

The device performance is reported by comparing its characteristics directly to these predicate devices.

Study Details

The provided document describes verification and validation activities rather than a traditional clinical study with a test set of patient cases. This is typical for a 510(k) modification aiming to demonstrate substantial equivalence, especially when the modification is primarily technological (adding a new parameter that leverages existing technology).

1. Sample size used for the test set and data provenance:

   • Test set: Not applicable in the sense of a clinical patient cohort. The testing described is system-level and software validation.
   • Data provenance: Not specified other than "performance tests designed to ensure that the device meets all functional requirements and performance specifications". It is implied that this testing was internal to Mennen Medical or conducted by approved testing bodies. The document does not mention data from human subjects or a clinical test set for the ICECG functionality.

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

   • Not applicable/Not specified. Ground truth in this context would refer to the established performance requirements of the predicate devices and industry standards. No mention of human expert adjudication for a "test set" of cases.

3. Adjudication method for the test set:

   • Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. The submission is for a device modification to add a measurement parameter, not a new diagnostic algorithm requiring comparative effectiveness against human readers.

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

   • The document implies that the performance tests were for the device's ability to acquire and display the ICECG signal correctly, which is a "standalone" or intrinsic performance evaluation of the hardware and software. The "stand-alone" performance criteria are tied to the specifications of the predicate EMS-XL system's ICECG measurement.

6. The type of ground truth used:

   • The ground truth for this submission is based on engineering specifications and established performance characteristics of the predicate devices (Horizon XVu and EMS-XL), as well as compliance with electrical safety and EMC standards (e.g., IEC 60601 series). The claim is that the new ICECG functionality performs equivalently to an already cleared device, and the overall system still performs equivalently to the original cleared Horizon XVu.

7. The sample size for the training set:

   • Not applicable. This is not a submission for an AI/ML algorithm that requires a training set of data. The "software" changes relate to displaying and controlling existing vital signs and the new ICECG, implying configuration and integration rather than learning.

8. How the ground truth for the training set was established:

   • Not applicable (as there is no training set for an AI/ML algorithm).

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The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.

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 Intended Use of the Horizon XVU is same as the Indications For Use as indicated above.

The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history.

The Horizon XVu is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature. Heart rate, multi-lead ECG, EtCO2 and BP waveforms from different heart and vascular 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 XVu is used for activities such as coronary and peripheral endovascular procedures and Angioplasty. The basic steps described above (catheter positioning, site definition/acquisition, analysis and acceptance) are performed as an integral part of these procedures.

The system has a Sun Ultra 25 computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard.

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

The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs (A) from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Horizon XVu device:

Important Note: The provided document is a 510(k) premarket notification for a device modification. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel clinical study with detailed acceptance criteria and performance metrics for an entirely new device. As such, the document primarily describes the device and its intended use, and explains why the modification does not alter its fundamental safety or effectiveness.

Therefore, the information you've requested regarding specific acceptance criteria, comprehensive study designs, sample sizes, expert qualifications, and detailed performance metrics is largely absent from this particular 510(k) document. The device is being cleared based on its similarity to a previously cleared device (Horizon SE) and the limited nature of the modification (primarily a GUI change).

Despite this, I will attempt to extract and infer what I can from the provided text to address your points, acknowledging where information is not present.

Acceptance Criteria and Device Performance

Due to the nature of this 510(k) (device modification, specifically a GUI change), the document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new device's clinical trial results. The "performance" being validated here is primarily that the new GUI does not negatively impact the existing functionalities and performance of the predicate device.

The implicit acceptance criteria for this modification are:

• Functional Equivalence: The Horizon XVu performs all the functions of the Horizon SE.
• Safety Equivalence: The GUI change does not introduce new safety risks.
• Effectiveness Equivalence: The GUI change does not negatively impact the device's ability to acquire, display, store, and analyze patient data effectively for its intended use.
• User Interface Improvement: The new GUI is "more user-friendly" and has a "modern look" with "better contrast and easier user interface."

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly mentioned. Given this is a GUI change to an existing device, a formal "test set" in the sense of a new clinical study with patient data is unlikely to have been conducted for this 510(k). The focus would be on internal verification and validation of the software change.
   • Data Provenance: Not applicable in the context of a new clinical study. The device itself is manufactured in Israel ("Mennen Medical Ltd., 4 Hayarden Street, Yavne, 81228, Israel").

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

   • Not applicable. There is no mention of a "ground truth" derived by experts for a test set in this document, as it's a device modification focused on the user interface and functional equivalence, not a new diagnostic or prognostic tool requiring clinical adjudication.

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

   • Not applicable. No clinical test set or adjudication is described.

4. 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:

   • No. This device is a physiological monitoring system and is not described as having AI capabilities or undergoing an MRMC study for diagnostic effectiveness. It's an information display and management system.

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

   • Not applicable. This is not an algorithm-only device; it's a integrated system for acquiring and displaying physiological data for human interpretation and use in medical procedures.

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

   • Not applicable. No ground truth is described in this context. The "ground truth" for the device's accuracy in measuring ECG, BP, etc., would have been established during the original predicate device clearance (K032997) through calibration and performance testing against reference standards, not through expert consensus on patient data for this GUI update.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (physiological monitor with a specific GUI), not a machine learning or AI algorithm that requires a "training set" of data.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is described.

Summary of the 510(k) Scope:

This 510(k) (K081484) is a "Special 510(k)" for a "Device Modification - Horizon XVu." The core premise is that the Horizon XVu is "identical to the Horizon SE Cathlab but with different graphic user interface." The key justification for substantial equivalence lies in the fact that the underlying hardware, signal acquisition electronics (CFE), functions, and protocols were not changed. Only the "GUI view and colors" were modified to improve user-friendliness and provide a modern look. Therefore, the detailed studies and performance metrics typically expected for an entirely new device, or a device with new clinical claims, are not required or presented in this type of submission. The FDA's clearance (JUN 20 2008 letter) confirms that the device is "substantially equivalent" to its predicate, based on this scope.

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