(23 days)
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."
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Document) |
|---|---|
| Functional Equivalence to Predicate Device (Horizon SE): | |
| The Horizon XVu retains all previous functionalities for acquiring, displaying, storing, and analyzing vital sign data (ECG/HR, invasive BP, SpO2, respiration, cardiac output, body temp, EtCO2). | "The Horizon XVu is a system identical to the Horizon SE Cathlab but with different graphic user interface." |
| "The Horizon XVu uses the same CFE front end electronics and the same hardware platform as the Horizon SE." | |
| "The list of functions and protocols was not changed." | |
| "The control panels and information lists where not modified, but the GUI view and colors, were modified to use new colors with better contrast and easier user interface." | |
| "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." | |
| (This implies that the core functional performance matches the predicate, K032997, which was already cleared.) | |
| Safety Equivalence: | |
| No new safety hazards introduced by the GUI change. | Not explicitly stated as a tested outcome in the provided text, but implied by the 510(k) process for device modification, which assesses if the changes raise new questions of safety or effectiveness. The fundamental hardware and signal acquisition remain the same. |
| User Interface Improvement: | |
| Modern look, user-friendly, better contrast, easier interaction. | "This new GUI is more users friendly and will give the system a more modern look without changing the signal acquisition, storage and report capabilities." |
| "The advantages of the Horizon XVu on the Horizon SE Cathlab are: User friendly Modern look." | |
| "The GUI... were modified to use new colors with better contrast and easier user interface." |
Study Details (Based on available information)
-
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").
-
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.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication is described.
-
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.
-
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.
-
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.
-
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.
-
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.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).