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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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The Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive.

PAV+ is intended for use in hospitals and hospital-type facilities.

Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator that includes a spontaneous breath type called, Proportional Assist. PAV+ is designed to assist the spontaneous breathing patient with an active neural drive. Proportional Assist amplifies the patient's inspiratory effort. A control function allows the clinician to specify an amplification setting.

The provided text describes a 510(k) submission for the Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus (PAV+) software option, which is a continuous ventilator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or specific performance metrics that were established as targets for the PAV+ software. However, it indicates a qualitative acceptance criterion: "substantial equivalence" to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical simulation testing" and "Evaluations... conducted in a hospital setting" but does not provide specific sample sizes for these test sets. The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

The document states that "Clinical simulation testing was conducted to evaluate the PAV+ software in the hands of respiratory therapists." This implies that respiratory therapists were the users and evaluators, acting as a form of "expert" group. However, the exact number of these respiratory therapists and their specific qualifications (e.g., years of experience) are not provided. It's also unclear if they established a formal "ground truth" or simply provided feedback and assessments of the software's performance.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. It broadly refers to "evaluations."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study is mentioned. The device is a ventilator software option, not an imaging analysis tool that typically involves "readers" in the context of MRMC studies. The focus is on the software's performance and its interaction with a human operator (respiratory therapist) rather than improving human "reading" performance. Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in this context.

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

The document states, "Performance data includes results from testing at the system level and conducting testing on controls." This suggests some level of standalone testing of the algorithm's components or the overall system without direct human interaction at all times. However, the exact nature and extent of this standalone testing are not detailed. The "clinical simulation testing" and "evaluations... in a hospital setting" clearly involved human-in-the-loop performance.

7. The Type of Ground Truth Used

The document doesn't explicitly define a "ground truth" in the sense of a gold standard (like pathology or outcome data) for the PAV+ software's performance. Instead, the "ground truth" appears to be implicitly established by:

• Comparison to predicate devices: The functionality and performance of the PAV+ software were assessed against the known characteristics and performance of the Puritan Bennett 840 Ventilator with Volume Ventilation Plus and the Dräger EvitaXL with SmartCare/PS.
• Clinical judgment/experience of respiratory therapists during simulation and hospital evaluations.
• Measured characteristics of the patient (pulmonary compliance and total pulmonary resistance) as inputs for the PAV+'s proportional pressure augmentation, implying that the algorithm's calculations and subsequent actions were verifiable.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This submission is for a medical device software, and while software development typically involves training and testing, the regulatory filing focuses on the final performance demonstration. The term "training set" is usually associated with machine learning models, and while PAV+ involves complex algorithms, it's not explicitly framed as an AI/ML product requiring a distinct "training set" description in this 2006 K05.

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

As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided.

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