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The AURA Family of Ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support through invasive or non-invasive interfaces to individuals that require such medical care. Specifically, the AURA Family of Ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.).

The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician.

The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

The AURA Ventilator provides ventilatory support for infant, pediatric and adult patients. The AURA ventilator is a prescription device that can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician.

The AURA ventilator may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The AURA ventilator has A/CMV, SIMV, SPONT and VTPC ventilatory modes (Pressure or Volume).

The controls of the AURA ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The AURA has a Trends screen for displaying data graphically. User Help screens present information for all controls and features. The AURA family of ventilators has models that can be differentiated based on whether or not the device has SpO2 monitoring capability.

Here's a breakdown of the acceptance criteria and study information for the AURA Ventilator (K121891) based on the provided text:

Important Note: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and describes the general types of testing performed. It does not detail specific acceptance criteria values (e.g., a specific pressure accuracy tolerance) or the direct results showing compliance with those values for each test. Instead, it broadly states that "all of which confirms that the device meets its design, performance, and electrical safety requirements" and "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties."

Therefore, the table below reflects the categories of performance that were tested, as outlined in the "Nonclinical Data" section, rather than precise numerical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify discrete "test sets" or their sample sizes in terms of patient data or case numbers. The testing described is
  primarily nonclinical verification and validation testing on the device itself (e.g., performance of various ventilatory functions, electrical safety, usability).
• Data Provenance: Not applicable as the testing described is primarily laboratory/engineering testing of the device, not a study involving patient data.

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

• Not applicable. The "ground truth" for this type of nonclinical device testing is established by engineering specifications, regulatory standards, and generally accepted principles of ventilator function, rather than expert consensus on medical images or patient outcomes. The "Usability Test on Less Trained Users" implies involvement of human testers, but details on the number or their "qualifications" beyond being "less trained users" are not provided.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human readers are interpreting data (like medical images) and their discrepancies need to be resolved. This document describes device performance testing.

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

• No, an MRMC comparative effectiveness study was not explicitly described or conducted. The submission focuses on device performance and substantial equivalence to existing predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, implicitly. The "Nonclinical Data" section describes extensive verification and validation testing of the AURA ventilator's various functions (e.g., volume control, pressure support, alarms, battery life). This testing inherently evaluates the device's performance in a standalone capacity, ensuring it meets its specifications without human intervention during its functional operation. (Note: This is different from a standalone AI algorithm's performance in interpreting data.)

7. Type of Ground Truth Used

• The ground truth used for the described nonclinical testing is based on engineering specifications, design requirements, and applicable regulatory/performance standards for ventilators.

8. Sample Size for the Training Set

• Not applicable. This document describes the development and testing of a medical device (ventilator hardware/software), not an AI algorithm that requires a "training set" of data in the machine learning sense.

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

• Not applicable for the same reason as point 8.

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