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The 2300 Series mGO Portable Oxygen Generalor is 1-3 1./min continuous flow (1-6 1./min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based in molecular sieve technology. The patient the oxygen through a nasal cannula.

The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.

A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow serings should be adjusted only under the direction of a Physician.

WARNING: Federal Law restricts this device to sale by or on order of a Physician

The 2300 Series mGO Portable Oxygen Generator delivers supplementary oxygen to casualties and patients at the point of need, eliminating the need for oxygen cylinders. It is designed to function in harsh environments for military users and agencies engaged in humanitarian and relief operations.

The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32. The 2300 Series mGO can deliver oxygen at flow rates between 1 and 3 litres per minute (L/min), continuous flow, or, in pulse dose mode, an oxygen bolus of up to 84 millilitres (ml) (14 ml multiplied by the setting value, maximum of 6) equivalent to a continuous flow of 6 L/min in response to breath demand. This is termed Pulse Oximetry.

The 2300 Series mGO is based on the pressure swing adsorption (PSA) principle. The 2300 Series mGQ delivers supplemental oxygen for patients through molecular sieve beds and is designed to conserve the use of oxygen in pulse dose mode. In pulse dose mode, oxygen is delivered to the patient through a pulse dose valve when a patient starts to inhale.

Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor.

A poppet-style solenoid valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases, while oxygen flows out of the sieve bed, thereby producing a highly enriched oxygen product. Simultaneously, in the second sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. The cycle continues by alternately swapping the absorption/desorption process from one sieve bed to the other, providing a flow of oxygen to a receiver and the patient through a bacteria filter.

The 2300 Series mGO consists of pneumatic and electrical components, a pressure and vacuum compressor, a pressure vessel, Synthetic Zeolite molecular sieve beds, two lithium ion batteries, dust separator and particulate inlet filter, valve assemblies, an outlet bacteria filter, electronic flow control, touch control pad, a cooling fan assembly, and audible/visual alarms.

The 2300 Series mGO operates from 100-240 Volts AC mains power, 24-28 Volts DC power or two removable rechargeable batteries. The 2300 Series mGO may be carried manually (weight

The provided text describes the 510(k) summary for the 2300 Series mGO Portable Oxygen Generator. It details the device's characteristics, comparison to predicate devices, and non-clinical testing. However, it explicitly states that no clinical tests were submitted and therefore, it does not contain a study proving the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on:

• Analogy and substantial equivalence to a predicate device (DeVilbiss Healthcare iGO Portable Oxygen Generator, K081468) and a second predicate device (SeQual Technologies Inc. SAROS 3000, K083163).
• Non-clinical testing to demonstrate performance and safety.

Given the lack of a clinical study, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance, ground truth for test set/training set) cannot be answered as they pertain to clinical or algorithm-based performance evaluations.

Here's a summary of the information that can be extracted related to acceptance criteria and performance, primarily from non-clinical testing and analogy:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The studies are non-clinical, primarily engineering and performance tests on the device itself or components, or reliance on "analogy and read-across" from predicate device testing. For example, the Extended Life Test mentions one device operating for 3778 hours with 2 failures, or a pressure test on one "Accumulator & Filter Housing Assembly."
   • Data Provenance: The provenance is primarily laboratory testing conducted by Intertek Testing and Certification Limited and internal reports. Where analogy is used, the data provenance traces back to tests performed on the predicate device (DeVilbiss Healthcare 306 Series iGO, K081468). These are retrospective for the predicate device and inherently non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no human-interpreted "ground truth" for these non-clinical engineering and performance tests.

4. Adjudication method for the test set: Not applicable, as there is no human-interpreted "ground truth" requiring adjudication.

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: Not applicable. This is not an AI-based device, and no clinical or comparative effectiveness study involving human readers was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device. The non-clinical tests are standalone in the sense that they evaluate the device's physical and functional performance directly.

7. The type of ground truth used:

   • For non-clinical tests, the "ground truth" is defined by the measured physical properties and performance characteristics of the device or its components, as per established engineering standards (e.g., IEC 60601-1, ISO 8359).
   • For aspects relying on analogy, the "ground truth" is inferred from the documented performance of the predicate device.

8. The sample size for the training set: Not applicable. This is not a machine learning/AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set.

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