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The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Respiratory Therapists and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.

The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. In addition, in spontaneous mode, it can be used to monitor anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.

The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.

The provided document is a 510(k) summary for the AV-S Anaesthesia Ventilator. It focuses on demonstrating substantial equivalence to predicate devices and outlines the device's technical characteristics and intended use. Crucially, this document does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication for performance evaluation studies.

The text consistently refers to the device as an "Anaesthesia Ventilator" and its purpose is for "continuous mechanical ventilatory support during general anaesthesia." It emphasizes the similarities with predicate devices (Penlon Limited AV800 Anaesthesia Ventilator and Datex-Ohmeda 7900 Anaesthesia Ventilator) in terms of software control, multi-mode functionality, and indications for use. The only noted technological differences are the incorporation of the Prima Oxygen monitor and additional software for advanced spontaneous breathing support modes.

Since the document does not contain the requested information about acceptance criteria and performance studies, I am unable to populate the table or provide details for points 2 through 9.

Therefore, the response for the requested information is that it is not present in the provided text.

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This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. 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. 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 tot he patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. 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. 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 tot he patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

The Datex-Ohmeda 7900 Ventilator Enhancements to the Aestiva/5 Anesthesia System is a pneumatically driven, microprocessor-based, electronically controlled ventilator that provides patient ventilation during surgical procedures. The device includes a built-in monitoring system for inspired oxygen, airway pressure, and exhaled volume.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on regulatory substantial equivalence based on compliance with voluntary standards and comparisons to predicate devices, rather than explicit performance-based acceptance criteria with specific numerical targets. The "reported device performance" in this context refers to its successful validation against these standards and its similar functionality to predicate devices.

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

The document does not detail specific "test sets" or "data provenance" in the context of clinical studies for performance metrics. The validation is described as "rigorous testing" to ensure compliance with voluntary standards. This suggests engineering and bench testing, rather than a clinical trial with a patient test set.

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

Not applicable. The document describes compliance with engineering and electrical safety standards, as well as functional equivalence to predicate devices, not interpretation of clinical data by experts.

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

Not applicable. There is no mention of a clinical test set requiring 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

Not applicable. This is a ventilation device; its approval does not involve AI assistance or MRMC studies.

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

Not applicable. This is a medical device, and its performance is assessed against established engineering and safety standards, and functional equivalence, not as an algorithm's standalone performance.

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

The "ground truth" in this context is the successful demonstration of compliance with the detailed requirements outlined in the voluntary consensus standards (UL, EN/IEC, ASTM, ISO) and the functional specifications of the device itself, proving its substantial equivalence to the predicate devices. This involves engineering specifications, technical testing, and regulatory requirements rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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