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The Servo-u Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-n Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities

The Servo-u MR Ventilator System is:

• intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
• to be used only by healthcare providers
• to be used only in professional healthcare facilities and for transport within these facilities
• to be used in MR environment according to specified conditions
• with 1.5 T or 3 T MR scanners
• outside magnetic fields >20 mT/200 Gauss

The Servo-u/n/u MR Ventilator Systems 4.1 consist of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.

The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.

The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.

NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.

Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).

The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).

Based on the provided text, the device in question is the "Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1". This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

*Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data in the context of an AI/human reader study. It focuses on the technical modifications, safety, and regulatory compliance of a medical device (ventilator systems) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information for the following reasons:

• No AI component or human reader study: The document describes hardware and software updates to ventilator systems. There is no mention of an Artificial Intelligence (AI) component or any study involving human readers or expert consensus on clinical images/data.
• Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the updated ventilator systems are "substantially equivalent" to previously cleared predicate devices, primarily through engineering testing, software verification, and adherence to performance standards, not through clinical comparative effectiveness trials in the way an AI diagnostic tool would be evaluated.
• Type of Testing: The non-clinical testing listed (code review, static code analysis, unit tests, integration tests, specification and system-level verification testing, waveform testing, biocompatibility, human factors validation testing) are typical for medical device development to ensure functionality and safety, not AI model performance.

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI device meets those criteria. The document pertains to the clearance of ventilator systems, not an AI diagnostic or assistive device.

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The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (information systems) it is connected to.

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors.

The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

This document primarily describes a 510(k) premarket notification for the GE Healthcare Unity Network ID, focusing on its substantial equivalence to a predicate device, Unity Network ID V8 (K170199). It does not contain information about acceptance criteria for device performance with specific metrics or detailed study results where a device's performance is measured against those criteria.

The information provided describes the device's function (data collection and clinical information management), its intended use, and the changes made from the predicate device (primarily software updates to support new third-party devices).

However, it explicitly states:
"The Unity Network ID V9 was tested to assure that the device meets its design specifications. Testing included all new or modified features."
and
"The subject of this premarket submission, Unity Network ID V9, did not require clinical studies to support substantial equivalence."

Therefore, based on the provided text, I cannot describe the acceptance criteria and study as requested, because specific performance acceptance criteria and a study demonstrating the device meets those criteria are not detailed.

The document only states that non-clinical tests were performed to ensure compliance with voluntary standards and design specifications. It lists general quality assurance measures applied during development and testing but does not provide specific performance metrics, sample sizes, ground truth establishment, or expert involvement as typically found in a clinical performance study for AI/machine learning devices.

Here's a breakdown of the specific points you requested, noting what is and isn't available in the provided text:

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

   • Not Available: The document does not provide a table of acceptance criteria nor reported device performance metrics against such criteria. It states the device "meets its design specifications" and "comply with, applicable voluntary standards," but no specifics are given.

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

   • Not Available: No test set sample sizes or data provenance are mentioned as no clinical studies were performed. The testing described is non-clinical verification and validation of design specifications.

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 Available: Since no clinical studies were required and no test sets with ground truth are described, there is no information about experts establishing ground truth.

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

   • Not Applicable/Not Available: No clinical test set or adjudication method is described.

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/Not Available: This device is a data collection and management system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

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

   • Not Applicable/Not Available: This device is not an algorithm for diagnostic or prognostic purposes, but rather an interface for data transmission. Standalone performance in the context of an algorithm is not relevant here.

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

   • Not Applicable/Not Available: No ground truth in the context of a clinical performance study is mentioned.

8. The sample size for the training set

   • Not Applicable/Not Available: This device is not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would involve configuring it to correctly interpret and transmit data from specific third-party devices, which is part of its design and verification process, not a machine learning training process.

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

   • Not Applicable/Not Available: See point 8.

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