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The SA Ve II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe 11™ series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.

The SAVe II™ and SAVe II™ Basic ventilators are battery powered compressors to deliver automated, controlled positive pressure breaths with ambient air for up to 10 hours. It is designed to augment the capabilities of first responders by supplementing Bag Valve Mask (BVM) manual ventilation delivery with an automated solution that can be rapidly deployed by minimally skilled providers in environments where compressed oxygen is unavailable or ill-advised.

To support use in emergency situations, the SA Ve II™ is portable and easy to carry. Rapid initial setup is enabled by default ventilator settings based on adult patient's height, ranging from 4'6'' to 6'6" weighing at least 45 kg, organized in a circular-shaped graphic. To mitigate the risk of patient injury, airway pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. Immediate patient injury due to high pressure is avoided by a pressure cut-off that triggers an exhalation if inspiratory pressure exceeds device settings. Rapid troubleshooting is enabled by visual alarm indicators located together at the bottom of the unit that identifies the most likely cause of the triggered alarm.

Here's a breakdown of the acceptance criteria and the study method for the AutoMedx SAVe II™ and SAVe II™ Basic devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria with specific acceptance thresholds. The "acceptance criteria" are implied by the features and performance characteristics of the predicate devices. The reported device performance aligns with these characteristics.

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

The document primarily describes bench testing rather than studies involving human subjects or real-world data.

• Sample Size: Not specified in terms of numerical units like "cases" or "patients." The testing involved "a complete set of performance testing to the device specifications" and "comparative bench testing to the predicate."
• Data Provenance: Not applicable in the traditional sense of clinical data. The data is generated from non-clinical bench testing performed by the manufacturer, AutoMedx, Inc. The nature of this testing does not involve country of origin in the context of patient data. It is prospective in the sense that the tests were conducted specifically for this submission.

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

Not applicable. The ground truth for bench testing is established by the device's technical specifications and the performance of the predicate device. It does not involve expert image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or interpretation where adjudication would be necessary. Performance is measured against engineering specifications and comparison to the predicate's technical characteristics.

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

No MRMC comparative effectiveness study was done. This medical device (a ventilator) is not an AI-assisted diagnostic or interpretive tool where human reader performance would be a primary metric.

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

Yes, the primary evaluation involved standalone bench testing of the device's performance against its specifications and comparison to predicate devices' technical characteristics. This is an "algorithm only" performance (referring to the device's internal software controlling ventilation parameters), without a human in the loop for interpreting the device's output in the way one would for an AI diagnostic tool. Instead, the device itself delivers the therapy.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Device specifications: The SAVe II™ and SAVe II™ Basic were tested to ensure they met their own predefined performance requirements.
• Predicate device characteristics: The performance of the SAVe II™ models was compared against the known characteristics and performance of the predicate devices (Impact Instruments - Uni-Vent Model 754 - K931473 and AutoMedx - SAVe™ - K071221). Substantial equivalence was claimed if the device performed comparably or better (e.g., in terms of battery life or alarms).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set" in the context of data-driven model development. The device's operation is based on pre-programmed logic and control algorithms.

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

Not applicable, as no training set was used.

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