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The SAVe is intended for use on adults that need ventilatory support. Specifically, the SAVe is intended to provide short term ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. The SAVe device is appropriate for individuals that weigh at least 45 kilograms. It is intended to be used in field hospitals, transport and prehospital environments.

The SAVe is a time cycled ventilator that delivers a set tidal volume. If, at any point, an upper threshold pressure is reached, the device immediately triggers the exhale mode. The SAVe consists of an internal pump (blower), rechargeable sealed lead acid battery, circuit board, manifold, face plate, EMI shielded upper and lower enclosure, air intake port with debris filter, patient port, pressure port, supplemental air / oxygen port, electric port for recharging and / or running, charger / power supply, patient circuit, pressure tubing, oxygen tubing and an activation switch. The device has audio and visual alarms that trigger for low pressure, disconnect, blockage, low battery, high temperature or internal failure. The device not only alarms for stacked breaths but also cuts off the pump until adequate pressure has been released before triggering the next breath. The SAVe comes in three distinct models. Each has a set tidal volume and respiratory rate. Model 550x10 delivers 550 mL of air 10 times per minute. Model 600x10 delivers 600 mL of air 10 times per minute and Model 600x12 delivers 600 mL of air 12 times per minute.

The provided text describes a 510(k) submission for a medical device called the "Simplified Automated Ventilator - SAVe." The submission focuses on demonstrating substantial equivalence to a predicate device, the Impact Uni-Vent 754.

Acceptance Criteria and Device Performance:

The document does not explicitly state numerical "acceptance criteria" as would be found in a performance goal for a diagnostic device. Instead, the performance evaluation is based on demonstrating substantial equivalence to the predicate device, the Impact Uni-Vent 754.

The "reported device performance" is a qualitative statement of equivalence to the predicate device.

Study Details:

The provided text describes a substantial equivalence study for a medical device (ventilator), not a diagnostic algorithm. Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, and training set sample size) are not applicable or not detailed in this type of submission.

Here's an analysis based on the information provided:

1. Sample size used for the test set and the data provenance: Not explicitly stated. The evaluation was primarily based on bench tests and potentially external third-party tests. The provenance of this test data is implied to be from the manufacturer (Automedx) and external testing agencies.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a ventilator, ground truth isn't established by experts in the same way as for a diagnostic imaging algorithm. Performance is assessed against engineering specifications, simulated physiological conditions, and comparison to a predicate device.
3. Adjudication method for the test set: Not applicable. Performance is measured against physical parameters and predicate device performance.
4. 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 ventilator, not a diagnostic AI algorithm for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Simplified Automated Ventilator," implying it operates autonomously in its core function of delivering ventilation. Performance data was generated from bench tests, which would assess its standalone mechanical and electronic function.
6. The type of ground truth used:
   • Engineering specifications/performance metrics: The device's ability to deliver preset tidal volumes and respiratory rates, trigger exhale mode at an upper threshold pressure, and its alarm functions.
   • Predicate device performance: Comparative data showing the SAVe performs "as safe and effective as the Uni-Vent 754" at the prescribed settings.
   • Compliance with standards: Functioning as intended according to standards for electromagnetic compatibility and air quality.
7. The sample size for the training set: Not applicable. Ventilators are typically designed and calibrated based on engineering principles and preclinical testing, not "trained" on a dataset in the way a machine learning algorithm is.
8. How the ground truth for the training set was established: Not applicable for this type of device. The design specifications and performance parameters derive from medical requirements for ventilation and the characteristics of the predicate device.

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