(127 days)
The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.
Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.
Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.
Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.
Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.
The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.
Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.
The provided document is a 510(k) summary for the Skyline 55 Version 1 Central Nursing Station software. It compares the device to predicate devices and states its intended use. However, it does not include detailed information regarding specific acceptance criteria, test methodologies, sample sizes for test sets, expert qualifications, adjudication methods, or separate training set details, which are typical for studies proving device performance.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed performance study with acceptance criteria in the manner often seen for novel algorithms or diagnostic devices. Substantial equivalence relies on comparing the technological characteristics and intended use of the new device to a predicate.
Based on the provided text, here's what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit "acceptance criteria" and "reported device performance" in a quantitative, metrics-based format typically used for evaluating the diagnostic performance of a device (e.g., sensitivity, specificity, accuracy against a gold standard).
Instead, the conclusion of the 510(k) summary acts as the overarching "acceptance," stating:
"The conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)."
This is a qualitative statement of equivalence, not a quantitative performance report against a set of statistical criteria. The "performance" is implicitly deemed equivalent to the predicate devices through functional comparison and validation.
Instead of a criteria table, the document provides a "Technological Characteristics" comparison with predicate devices:
| Feature/Characteristic | Skyline 55 Ver1 (New Device) | HypervisorVI (Predicate 1) | Skyline 55 Ver0 (Predicate 2) |
|---|---|---|---|
| Intended Use | Centralized patient monitoring for adult, pediatric, neonatal patients in a hospital. Secondary display/announcement for physiological parameters. Not a patient monitoring device (clinician references primary bedside monitor). Not for home use. | Centralized patient monitoring in a hospital. | Centralized patient monitoring in a hospital. |
| Connection | Wired Ethernet 802.3 and wireless 802.11bg | Wired Ethernet 802.3 and 802.11 (wireless) | Wired Ethernet 802.3 and 802.11 (wireless) |
| Operating System | Windows XP | Windows XP | Windows XP |
| PC Processor (Host CPU) | Core 2 duo processor 1.8 GHz | P IV 2.0G | (Not specified, assumed less than Ver1 due to upgrades) |
| Max. Simultaneous Monitors | 16 | 32 | (Not specified, implied less than Ver1 due to upgrades) |
| Max. Displays | 1 | 1 or 2 | (Not specified) |
| Recorder Provision | No dedicated provision (uses standard printer) | Yes | (Not specified) |
| Printer Functionality | Standard computer printer for parameter trend, alarm recall, patient discharge summary. | (Implied standard printing functionality) | (Implied standard printing functionality) |
| 72-hour Trend Data Storage | Yes (Waveform recall, Graphical, Tabular) | (Implied) | Extended from 24 hours in Ver0 to 72 hours in Ver1 |
| 72-hour Alarm Records Storage | Yes | (Implied) | Extended from 24 hours in Ver0 to 72 hours in Ver1 |
| ECG + 2 user selectable waveform storage for 72 hours | Added in Ver1 | (Implied) | Not present in Ver0 |
| Monitor to CNS bi-directional patient admission | Added in Ver1 | (Implied) | Not present in Ver0 |
| ECG strip for 36 seconds for each alarm in last 72 hours | Added in Ver1 | (Implied) | Not present in Ver0 |
2. Sample size used for the test set and data provenance
The document states "testing and validation of Skyline 55 Ver1" was performed, but does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for performance studies of diagnostic or AI-driven systems, but less so for substantial equivalence evaluations of monitoring software which rely more on functional verification and validation.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided in the document. The concept of "ground truth" established by experts is usually relevant for diagnostic devices where accuracy is assessed against expert opinion or definitive diagnostic methods. For a central nursing station software, the primary "truth" is the data transmitted from the bedside monitors, and the software's performance is gauged by its ability to accurately receive, display, and manage this data.
4. Adjudication method for the test set
This information is not provided. Given the nature of the device (central monitoring software, not a diagnostic algorithm requiring interpretation), an adjudication method for a test set (e.g., 2+1, 3+1) is unlikely to be applicable or described in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and effect size of human readers improving with AI vs without AI assistance
An MRMC study was not conducted or described. This type of study is typically performed for AI or CAD devices where the AI is intended to assist human readers in making a diagnosis or improving efficiency. The Skyline 55 is a central monitoring system, not an AI-assisted diagnostic tool. Its purpose is to aggregate and display data from bedside monitors, not to interpret or assist in interpretation in a manner that would be assessed via MRMC.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study for an algorithm. The Skyline 55 is described as software for a "Central Nursing Station" which provides a "secondary display/announcement" for physiological parameters, emphasizing that it is "NOT a patient monitoring device" and clinicians should "always reference the primary bedside monitor." This implies the device's role is inherently "human-in-the-loop" as a data display and alert system, rather than a standalone diagnostic algorithm.
7. The type of ground truth used
The "ground truth" for verifying the functionality of the Skyline 55 Ver1 is implicitly the physiological data transmitted from cleared bedside monitors. The software's performance is validated by its ability to accurately receive, display, and store this information, as well as correctly generate alarms based on parameters from these primary sources. There's no indication of 'pathology' or 'outcomes data' being used as ground truth for this device's performance.
8. The sample size for the training set
This information is not provided. As this is software for a central monitoring system, designed for data display and management rather than a machine learning or AI algorithm, the concept of a "training set" in the context of model development is not directly applicable in the typical sense. The software would have undergone standard software development, verification, and validation, which might involve testing with simulated or captured data, but not a "training set" for an algorithm.
9. How the ground truth for the training set was established
This information is not provided, and as explained above, the concept of a "training set" for this type of software is not explicitly detailed or applicable in the way it would be for an AI device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).