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The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3, 5, 6 and 12 lead measurements
• Heart Rate
• Pulse Oximetry (SpO2)
• ST Segment Analysis
• Arrhythmia Detection
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP)
• Cardiac Output (CO)
• Respiratory Gasses
• Respiration Rate
• Temperature

The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

The target populations are adult, pediatric and neonate with the exception of:

• Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only,
• IV Drug Calculations for which the target population is adult only, and
• Cardiac Output for which the target population is adult and pediatric only.

The Endeavour Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows users to customize monitored parameters based on a patients monitoring need or acuity level.

Here's an analysis of the provided text regarding the Endeavour Monitoring System's acceptance criteria and study information:

Acceptance Criteria and Device Performance for Endeavour Monitoring System

This summary is based on the provided 510(k) submission for the Endeavour Monitoring System (K102004).

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on compliance with established medical device standards and a clinical study comparing Non-Invasive Blood Pressure (NIBP) measurement. Specific quantitative acceptance criteria for each physiological parameter were not explicitly detailed in the provided text, but compliance with relevant IEC, ISO, AAMI, and ASTM standards serves as the implicit acceptance criteria for most parameters.

For the NIBP module, the acceptance criterion was implicitly defined by demonstrating no statistically significant difference in mean readings compared to the predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for NIBP Clinical Study: The specific number of subjects in the clinical study for NIBP is not mentioned in the provided text. It is only referred to as a "non-significant risk study."
• Data Provenance: The document does not specify the country of origin of the data. The study was a "non-significant risk study," which implies it was a prospective study.

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

For the NIBP clinical study, the ground truth was established by comparison to the predicate device, the Accutorr Plus Monitor (K983575). The text does not mention the use of experts to establish a separate ground truth or their qualifications. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set

Since the NIBP study compared the device to a predicate device, there's no mention of an adjudication method in the traditional sense (e.g., 2+1 or 3+1 expert consensus) as would be seen in image interpretation or diagnostic studies. The comparison was likely a direct measurement comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This device is a physiological monitoring system and not an AI-based diagnostic tool that would typically involve human readers interpreting output. The study focused on the performance of the NIBP module against a predicate device, not on how human readers' performance improved with or without AI assistance.

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

The NIBP clinical study appears to evaluate the device's NIBP algorithm in a standalone manner, comparing its measurements directly to a predicate device. While a human uses the device, the study's focus was on the machine's measurement accuracy versus another machine, not on human interpretation of the machine's output. Therefore, for the NIBP component, this was essentially a standalone performance evaluation of the measurement capability. For other parameters, compliance with standards (e.g., for heart rate, SpO2, etc.) also implies standalone verification of their algorithms/measurement capabilities.

7. The Type of Ground Truth Used

For the NIBP clinical study, the ground truth was the measurements obtained from the legally marketed predicate device, the Accutorr Plus Monitor (K983575). This is a form of comparative ground truth against an established and accepted reference.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is a physiological monitoring device, and the submission primarily focuses on compliance with established performance standards and validation against a predicate device, rather than the development and training of a machine learning algorithm.

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

As no training set is mentioned or implied for an AI/machine learning algorithm, this information is not applicable and not provided in the document. The device's performance is established through adherence to recognized standards and clinical comparison to a predicate.

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