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The GE Datex-Ohmeda S/5 ADU Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

The S/5 ADU (Anesthesia Delivery Unit) Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It is to be used only by trained and qualified medical professionals.

The S/5 ADU Carestation (shortened as ADU) supplies set flows of medical gases to the breathing system using mechanical gas mixing. Gas flows are selected by the user using the rotary controller on the frame and then displayed as electronic flow indicators on the system display unit. The ADU is equipped with a traditional flow tube, as well. The ADU is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The ADU comes with up to two optional gases (air, N2O). Safety features and devices within the ADU are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The anesthetic agent delivery for the ADU is controlled via an anesthesia computer through user input from that computer. An Aladin cassette is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The ADU is designed to allow only one active cassette at a time. Per the user input, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas within the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.

The ADU Anesthesia Ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. Sensors in the breathing circuit are used to control and monitor patient ventilation. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is reaulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV)Mode. Ventilator parameters and measurements are displayed on the system display unit.

The ADU must be used with additional monitoring that include at least inspired 02, expired volume, expired CO2 and Anesthetic Agent.

An RS-232 serial digital communications port connects to and communicates with external devices such a S/5 Anesthesia Monitor (most recently cleared via K051400). Several frame configurations are available, including one that allows for the physical integration of the S/5 Anesthesia Monitor. Additional configurations allow for the mounting of various patient monitors on the top shelf of the ADU.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda S/5 ADU Carestation:

Summary of Acceptance Criteria and Device Performance for K090892: GE Datex-Ohmeda S/5 ADU Carestation

It's important to note that this 510(k) submission is for a modification to a previously cleared device, not a completely new device entering the market. Therefore, the focus is on demonstrating that the changes do not introduce new questions of safety or effectiveness and that the modified device maintains performance equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an indirect set of "acceptance criteria" through compliance with recognized standards and a comparison to predicate devices, rather than specific performance metrics directly tied to a new clinical study. The device's performance is accepted if it meets these standards and is substantially equivalent.

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

The document explicitly states: "The modifications to the ADU did not require clinical testing."
Therefore, there is no specific test set or clinical data of human subjects mentioned in this submission. The evaluation relies on non-clinical testing and comparison to predicate devices.

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

Not applicable, as no clinical test set requiring expert-established ground truth was conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or mentioned, as no clinical testing was required for this 510(k). The evaluation revolves around engineering verification and validation.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study, in the traditional sense of an algorithm, was not performed, nor is it applicable to this device. This is a medical device (anesthesia machine) with hardware and software, not an AI/algorithm-only product. The non-clinical testing, including software validation, serves as the "standalone" evaluation of the device's functional and safety performance.

7. Type of Ground Truth Used (for any testing):

For the non-clinical testing mentioned, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• The requirements and performance benchmarks set by the listed national and international standards (e.g., UL, EN, IEC, ASTM, ISO).
• The established performance characteristics of the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is an anesthesia machine, not an AI model that requires a training set in the machine learning sense. The "training" for such a device effectively comes from its design, development, and adherence to established engineering principles and standards.

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

Not applicable. There is no training set in the context of machine learning for this device. The "ground truth" for its development is based on medical device design principles, safety standards, and functional requirements for anesthesia delivery and ventilation.

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