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The Infinity Acute Care System Workstations Neonatal Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal Care are intended to be used by qualified and trained medical personnel.

The Infinity C Series 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.

The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Babylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.

Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

The Infinity Acute Care System Workstation Neonatal Care provides Neonatal-Care specific functionality. It is made up of the ventilation unit Babylog VN500 and the Infinity Medical Cockpit C500.

The ventilation unit provides Neonatal-Care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit C500 is the control and display unit which runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit C500, which is also used to control ventilation settings including alarms.

The ventilation unit Babylog VN500 of the Infinity Acute Care System Workstation Neonatal Care is a microprocessor-controlled ventilator. The Babylog VN500 provides overpressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.

The ventilation application software on the Infinity Medical Cockpit C500 is needed to allow the user to display and control all ventilation parameters of the ventilation unit. The combination of the ventilation software application on the Infinity Medical Cockpit C500, together with the Babylog VN500, provides the functionality of a complete ventilator (e.g. Evita XL).

The ventilation application supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation, in addition to supporting graphical or textual display of historical data.

The Infinity Acute Care System can interface with specific Dräger Medical therapeutic and diagnostic equipment, as well as third party devices via a MEDIBUS data connection.

The user interface of the Infinity Acute Care System Workstation Neonatal Care is the Infinity Medical Cockpit C500, a standardized display and control unit for the connected monitoring and therapy units.

The Infinity Medical Cockpit C500 is a standard platform, using common hardware, software, and user interface components to facilitate ease of use for clinicians.

The provided text is a 510(k) summary for the Dräger Infinity Acute Care System Workstation Neonatal Care, a medical device that includes a ventilator. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards for safety and performance.

It is important to note that this document is a 510(k) summary for a ventilator, not an AI/ML-powered diagnostic device. Therefore, many of the requested criteria (such as sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are generally not applicable to this type of traditional medical device submission.

The document details the device's functionality, indications for use, and a list of performance testing against various IEC and ISO standards, as well as FDA guidance for ventilators. This performance testing confirms the device's safety and effectiveness according to established engineering and medical device standards.

Here's an attempt to address the requested information based on the provided text, indicating when information is not present or not applicable:

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

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

• Sample Size for Test Set: Not applicable/not mentioned. Traditional ventilator submissions typically involve bench testing, engineering verification and validation, and clinical good-use practices rather than test sets with patient data.
• Data Provenance: Not applicable. The testing is primarily engineering and performance-based, not data-driven in the sense of patient datasets.

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. The "ground truth" for a ventilator's performance is its ability to meet specified engineering and safety parameters, often validated by qualified engineers and verified through objective measurements against regulatory standards. There is no concept of "expert ground truth" in the diagnostic sense for this device.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or expert consensus on medical images or clinical cases. This is not relevant to a ventilator's 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. MRMC studies are used for evaluating the performance of diagnostic imaging devices, especially those involving human interpretation, and comparing human performance with and without AI assistance. This device is a ventilator, not a diagnostic AI tool.

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

• Not applicable. This device is a standalone ventilator system; however, it is not an algorithm-only device or an AI system that would have a "standalone" algorithmic performance distinct from its human-in-the-loop operation. Its performance is its standalone mechanical and electronic functionality.

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

• Type of Ground Truth: The "ground truth" for this device's performance is defined by its adherence to the specified technical standards (e.g., IEC 60601 series, ISO 14971) and functional specifications (e.g., accurate delivery of ventilation modes, stable oxygen concentration, correct alarm functionality). This is established through engineering testing, verification, and validation against a predetermined set of technical requirements and regulatory benchmarks.

8. The sample size for the training set

• Not applicable. This device is a traditional ventilator and does not employ AI/Machine Learning models that require training sets.

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

• Not applicable. No training set is used for this type of device.

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