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The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.

The Effortless Oxygen Conserver Systems (EOCS) is a microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver. Depending upon the model they have been designed for use in ambulatory, home and medical facility settings to supply medical-grade oxygen therapy to patients. The built in oxygen regulator reduces oxygen pressures from an oxygen cylinder or from hospital wall supplies. There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Effortless Oxygen Conserver System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with defined acceptance criteria for individual performance metrics like those typically outlined for AI/ML devices.

Therefore, the document does not contain the detailed information required to answer many of the questions, especially those pertaining to:

• Acceptance criteria table with reported device performance: The document only provides a comparison table of features and specifications between the proposed device and a predicate, not performance metrics against specific acceptance criteria.
• Sample size and data provenance for a test set: No test set (in the context of AI/ML or clinical efficacy) is mentioned. The "bench testing" refers to engineering verification.
• Number of experts and qualifications for ground truth: Not applicable, as there's no mention of expert-established ground truth for a test set.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Effect size of human readers improvement with AI assistance: Not applicable, as this is not an AI-assisted device in the diagnostic sense.
• Standalone performance (algorithm only): Not applicable for this type of device.
• Type of ground truth used: Not applicable.
• Sample size for training set and how ground truth was established for training set: Not applicable, as this is not an AI/ML device that requires training.

What the document does describe are several non-clinical tests to demonstrate device performance and safety, primarily for substantial equivalence to a predicate device, not clinical efficacy or AI/ML performance.

Here's an attempt to extract relevant information, acknowledging the limitations based on the document's content:

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

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the device's specifications and features, and states that various engineering and safety tests were performed to ensure it met applicable standards and performance requirements.

The "Table of Comparison and Differences" (Page 5-6) serves to show equivalence to the predicate device, not performance against specific criteria. However, for certain parameters, it implicitly suggests an acceptable range by stating what the device accomplishes.

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The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC) is similar to the predicate devices, pressure-vacuum swing adsorption based on molecular sieve technology using two containers filled with molecular sieve (sieve beds). Ambient air is drawn into the concentrator via a piston style compressor and compressed into a single sieve bed. As pressure increases nitrogen is adsorbed and concentrated oxygen exits one end of the bed and is collected in a product tank. Simultaneously in the other sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. Once the pressure or vacuum reaches a defined maximum a valve switches the compressor connections to the sieve beds. The sieve bed previously connected to the pressure head will be connected to vacuum. The oxygen collected in the product tank is then dispensed to the patient upon detecting a patient inhalation, much like an oxygen conserving device.

The proposed Drive DeVilbiss iGo2 POC provides pulse dose oxygen in the same manner as primary predicate device (DeVilbiss Model 306 POC, K081468). The "Smart Dose" feature has been added to the proposed device, which is substantially equivalent to the feature in the reference device (Model 350G gas conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing.

This document describes the regulatory filing for the Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC). It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical research sense.

However, based on the provided text, we can extract information regarding acceptance criteria for performance testing (non-clinical) and the types of studies conducted.

Here's a breakdown of the requested information:

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

The document states: "All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection." and "The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator was designed and tested to demonstrate compliance with the applicable sections of the following standards: ... passing all test protocols."

While specific numerical acceptance criteria and precise performance values are not fully detailed in a table format within the provided text, the document lists key performance specifications under the "Comparison of Substantial Equivalence and Differences" table. We can infer the acceptance criteria are met by confirming these specifications are in line with the predicate device or standards.

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