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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

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.

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The Marquette Eagle 4000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 4000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 4000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 4000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, respiration, apnea detection, pulse rate, cardiac output, and full arrhythmia analysis. The device now includes Marquette's 12 lead ECG Analysis program (commonly referred to as 12 SL).

The provided text is a 510(k) summary for the Marquette Eagle 4000 Patient Monitor, dated February 2, 1997. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed performance study with specific acceptance criteria and detailed quantitative results as might be found in a modern clinical trial or a more recent AI/ML device submission.

Therefore, much of the requested information cannot be extracted directly from this document because it predates the rigorous, quantitative evaluation standards common for AI/ML medical devices today. The summary primarily relies on a general statement of "verification and validation testing" and "accuracy requirements as specified in the contents of the premarket notification submission" without detailing the specifics of these tests or their results.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in a quantifiable way in this summary. The summary broadly states that "Test results indicate that the Eagle 4000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate devices when tested to the accuracy requirements as specified in the contents of the premarket notification submission." The "accuracy requirements" themselves are not provided.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, error rates) are reported in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The document does not describe the establishment of ground truth by independent experts in a test set, as would be common for AI/ML devices. The "verification and validation testing" likely refers to internal engineering and clinical validation testing against established standards or predicate device performance.

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

• Not applicable/Not specified. There is no mention of an adjudication process for a test set.

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

• No. This type of study (MRMC for AI assistance) is not mentioned and is highly unlikely given the device type (patient monitor) and the era (1997). The device provides physiological parameter monitoring and 12-lead ECG analysis, but there's no indication of it being an AI-assisted diagnostic tool that would improve human reader performance in the modern sense.

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

• Yes, implicitly. The performance evaluation would inherently be of the device's algorithms and hardware alone, as it's a patient monitor providing data and analysis. The "verification and validation testing" would assess the accuracy of its measurements and analyses (e.g., ECG, blood pressure, arrhythmia detection) as a standalone system. However, specific results are not provided.

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

• Not explicitly defined in the summary. For a patient monitor, ground truth would typically involve:
  • Reference Devices: Comparing measurements against highly accurate, calibrated reference instrumentation (e.g., for blood pressure, temperature, oxygen saturation).
  • Validated ECG Databases: For the "12 SL" ECG analysis program, ground truth might involve comparisons against widely accepted ECG databases with expert-adjudicated diagnoses, though this is not stated.
  • Clinical Observation: For arrhythmia detection, comparison against expert interpretation of concurrent ECG recordings.
• The summary only broadly refers to "accuracy requirements as specified in the contents of the premarket notification submission."

8. The sample size for the training set

• Not applicable/Not specified. The document does not mention "training sets" as it would for a machine learning device. The ECG analysis program would have been developed using a dataset, but it's not characterized as a "training set" in the context of modern ML.

9. How the ground truth for the training set was established

• Not applicable/Not specified. As no "training set" is described, its ground truth establishment is not discussed.

In summary, the provided 510(k) summary from 1997 is a regulatory declaration of substantial equivalence for a patient monitor and does not contain the detailed performance study information, acceptance criteria, or ground truth methodologies that are now standard for AI/ML device submissions. The document's purpose is to demonstrate that the Eagle 4000 is as safe and effective as its predicate devices based on general verification and validation testing, without providing the quantitative specifics you've requested.

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The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

The Marquette Eagle 3000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, and end tidal carbon dioxide (EtCO2). PA Wedge is also available. The Eagle 3000 Patient Monitor is a factory configured or fixed-parameter patient monitoring device. Options which allow for the monitoring of invasive blood pressure and the printing of information by a paper recorder may be added to the basic monitor configuration at the factory prior to shipment to the customer. The Eagle 3000 Patient Monitor has NOT been designed as a modular patient monitoring device which allows the addition and deletion of monitoring parameters at the point-of-use. The Eagle 3000 Patient Monitor has NOT been designed as a transport monitor. Therefore, no battery power feature or option has been included with this device.

Marquette Electronics, Inc. did not provide quantifiable acceptance criteria or device performance in the provided 510(k) summary (K960272). The summary broadly states that "Comparative testing was done on the Eagle 3000 Patient Monitor and its predicate devices. Precision and accuracy testing was also performed. Test results indicate that the Eagle 3000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate devices when tested to the accuracy requirements as specified in the contents of the premarket notification submission."

Therefore, I cannot populate the table or answer questions related to specific performance metrics, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided text.

Based on the available information:

• 1. Table of acceptance criteria and the reported device performance:
  Cannot be provided as this information is not present in the 510(k) summary. The summary only states that the device provides "an equivalent level or better in performance" compared to predicate devices.

• 2. Sample sized used for the test set and the data provenance:
  Not specified in the provided text.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  Not specified in the provided text.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  Not specified in the provided text.

• 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 device is a patient monitoring system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  Not applicable. This is a patient monitoring system, not an algorithm, and it explicitly states its use "by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment," implying human interaction.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  Not specified in the provided text. The summary only mentions "Precision and accuracy testing" against "accuracy requirements as specified in the contents of the premarket notification submission."

• 8. The sample size for the training set:
  Not applicable. This is a traditional patient monitoring system, and the concept of a "training set" for an algorithm is not mentioned.

• 9. How the ground truth for the training set was established:
  Not applicable, as there is no mention of a training set.

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