(168 days)
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet;
~permits integration to the network without physical connection to the Ethernet wall plate.
This device is viewed as a technology change and can be used with various other Marquette devices. Marquette has clearances for various patient monitors and its central station which are part of its wired Unity network. The intended patient population is limited to the same population as the device that the technology is being used with.
This device should be used by people who are trained in the use of the equipment.
This device is intended to be used within the hospital / facility environment.
The Marquette Eagle 4000 Patient Monitor is a multi-parameter patient monitoring system that is cleared to market as part of Marquette's wired Unity network. The Marquette Eagle 4000 Patient Monitor is now indicated for use on Marquette's wireless LAN.
Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability:
~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate.
The provided text describes a 510(k) submission (K971683) for a Wireless LAN (Local Area Network) - wireless Ethernet technology change, intended for use with Marquette Medical Systems' Eagle 4000 Patient Monitor. This document is focused on demonstrating the safety and effectiveness of the wireless networking capability, not on the performance of a diagnostic AI device.
Therefore, many of the requested elements for describing an AI device's performance acceptance criteria and study (such as sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and effect size with AI assistance) are not applicable to this submission.
The primary focus of this submission is to demonstrate that the wireless LAN, when integrated with an already cleared patient monitor, maintains the same level of safety and effectiveness as the wired version.
Here's an attempt to answer the applicable points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 601-1-1 (medical electrical equipment safety). | "The Wireless LAN device when used in conjunction with the patient monitor meets the safety requirements of IEC 601-1-1." |
| Compliance with IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz (IEEE C95.1-1991). | "It also meets the requirements of IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz (IEEE C95.1-1991) and has the appropriate FCC certification." | |
| Electromagnetic Compatibility (EMC) | Compliance with CISPR 11 Class A for both radiated and conducted emissions. | "Electromagnetic compatibility testing demonstrates that the device meets the requirements of CISPR 11 Class A for both radiated and conducted emissions." |
| Compliance with IEC 1000-4 series (immunity testing). | "Immunity testing demonstrates that the device meets the requirements of the IEC 1000-4 series and MIL-STD 462D." | |
| Compliance with MIL-STD 462D (immunity testing). | "Immunity testing demonstrates that the device meets the requirements of the IEC 1000-4 series and MIL-STD 462D." | |
| Performance/Equivalence | Equivalent level of performance to the wired LAN version of the Eagle 4000 Patient Monitor, specifically regarding accuracy requirements. | "Test results indicate that the Eagle 4000 Patient Monitor with wireless LAN provides an equivalent level in performance, when compared to the Eagle 4000 Patient Monitor with wired LAN, when tested to the accuracy requirements as specified in the contents of the premarket notification submission." |
| Identical networking function to standard Ethernet. | "Wireless LAN is a method of communicating to the Marquette Unity Network using a wireless connection. This capability: ~provides identical networking function to standard Ethernet; ~permits integration to the network without physical connection to the Ethernet wall plate." (Implied acceptance criterion: maintains existing functionality) |
2. Sample size used for the test set and the data provenance
The document indicates "Verification and validation testing was done on the wireless LAN in use with the Eagle 4000 Patient Monitor." However, it does not specify a sample size or data provenance in terms of patient data or case numbers. The testing appears to be focused on device-centric performance parameters (safety, EMC, and functional equivalence) rather than clinical patient data. The provenance for the testing is Marquette Medical Systems, based in Milwaukee, WI, USA. The testing context is implicitly prospective as it's about verifying a new technology integration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this submission revolves around engineering and regulatory standards for device safety, EMC, and networking functionality. It does not involve establishing a clinical "ground truth" requiring medical experts for diagnosis or outcome measurement. The "truth" is established by compliance to international and national standards by qualified engineers and testers.
4. Adjudication method for the test set
Not applicable. There is no indication of clinical adjudication or expert consensus methods for this type of technical performance testing.
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 submission is for a wireless networking component of a patient monitor, not an AI diagnostic device. No human-in-the-loop studies or AI-driven performance enhancements are discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This describes a hardware and software networking integration, not a standalone algorithm. The device's "performance" is its ability to transmit data reliably and safely, equivalent to a wired connection, and to comply with relevant safety and EMC standards.
7. The type of ground truth used
The "ground truth" for this submission refers to the compliance with established international and national technical standards (IEC 601-1-1, IEEE C95.1-1991, FCC certification, CISPR 11 Class A, IEC 1000-4 series, MIL-STD 462D) and the functional equivalence of networking capabilities between wired and wireless configurations.
8. The sample size for the training set
Not applicable. This device integrates a wireless LAN, it is not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in this context.
§ 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).