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Intended Use

Infinity® Acute Care System™ (IACS)

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The IACS, in connection with the M540 Patient Monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).

Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multiparameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The M540 monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices: Infinity M540 Patient Monitor (Model #MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model #MK31501 - 17" screen or Model MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without integration with the Infinity Medical Cockpits.

Associated accessories may include:

• Infinity MCable Masimo SET Model #MS20667
• Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
• Infinity MCable – Nellcor OxiMax – Model #MS20668
• Infinity MPod Quad Hemo Model #MS20725
• Infinity MCable Dual Hemo Model #MS20783
• Infinity MCable Mainstream CO2 Model #6871950
• Infinity MCable - Analog/Sync - Model #MS20662
• Infinity MCable – Nurse Call – Model #8417370
• PS120 Desktop Power Supply - Model #2606270
• Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

The provided document is a 510(k) summary for the Draeger Infinity Acute Care System (IACS) Monitoring System. It details changes and improvements to an existing device rather than a new AI-powered diagnostic device. Therefore, it does not contain the typical acceptance criteria and study information aligned with the questions.

Specifically:

• It appears to be an update (VG4.1.1) to existing Infinity Acute Care System (IACS) Monitoring System software and associated components.
• The document indicates that clinical studies were not performed or required for the device modifications. This means there isn't a study that "proves the device meets the acceptance criteria" in the context of typical AI diagnostic device studies involving ground truth from experts or pathology.

However, based on the information provided, here's what can be extracted and inferred, addressing as many points as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, performance metric table for an AI algorithm. Instead, it focuses on compliance with standards and verification testing for functions.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of an AI-powered diagnostic study with a discrete test set. The document indicates "Verification testing was conducted to confirm the new requirements... based on the differences between the subject and predicate devices." This implies various specific tests against functional requirements and standards, not a single patient-level test set for an algorithm's diagnostic performance.
• Data Provenance: Not applicable for this type of submission which focuses on verification of software and hardware changes against established standards, rather than analyzing patient data for a diagnostic algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided because the submission does not involve external "experts" establishing ground truth for a diagnostic algorithm's test set. The ground truth for this device's performance is based on compliance with electrical safety, EMC, and specific physiological parameter standards (e.g., EC57 for cardiac rhythm and ST segment algorithms).

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

• Not applicable, as there is no diagnostic image/signal interpretation dataset requiring expert adjudication.

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, an MRMC study was not done. The document explicitly states: "Clinical studies were not performed or required for the device modifications subject of this 510(k)." The device is a patient monitoring system, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

• While the system has algorithms (e.g., for arrhythmia, ST segment), the submission does not detail standalone performance testing in the manner of an AI diagnostic algorithm. The "Major Level of Concern" for software indicates that the algorithms directly drive clinical decisions and thus misapplication could cause serious injury or death, suggesting the critical nature of their standalone accuracy. However, formal standalone performance metrics (e.g., sensitivity, specificity) with a defined dataset for these specific algorithms are not reported in this summary beyond compliance with standards like EC57.

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

• For the performance data mentioned (e.g., EC57 testing for cardiac rhythm and ST segment measurement algorithms), the "ground truth" would be established by reference standards or simulated physiological signals that mimic known conditions, against which the device's measurements are compared for accuracy and adherence to a recognized standard. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm trained on a dataset of patient cases. The software updates involve improvements and corrections to existing functionalities and compliance with standards.

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

• Not applicable, as no training set for an AI algorithm is mentioned or implied.

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