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The Deployable Oxygen Generator System - Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.

The DOGS-S system is a portable battery powered oxygen concentrator that will be operationally used for ground-based medical assemblages, such as the Expeditionary Medical Support (EMEDS), and En-Route Patient Staging System (ERPSS) in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.

The provided text describes a 510(k) premarket notification for a medical device called the "Deployable Oxygen Generator System - Small (DOGS-S)". This document focuses on demonstrating substantial equivalence to a predicate device (OMNI 2 (SAROS)), not on proving the device meets individual acceptance criteria through a clinical study in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and are not present in the document.

The document primarily focuses on bench testing to confirm the device's technical specifications and compliance with relevant engineering and safety standards.

Here's an analysis based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the typical format of a clinical performance study with specific metrics and thresholds (e.g., sensitivity, specificity). Instead, it provides a comparison table of technological characteristics between the DOGS-S device and its predicate, the OMNI 2 (SAROS), to demonstrate substantial equivalence. The "acceptance" here is that the DOGS-S performs comparably or meets the standards for an oxygen concentrator.

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