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Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

The Oxlife Independence Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are nonsterile.

The Oxlife Independence Oxygen Concentrator provides approximately 90% oxygen to the patient on continuous to 3 and on a conserver flow basis at an "equivalent" rate of 1.0 liters per minute to 6.0 liters to minute. The Oxlife Independence Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110-220 VAC, 12-14 VDC or rechargeable batteries.

The Oxlife Independence Oxygen Concentrator uses molecular sieve adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from molecular sieve, allowing it to adsorb again during next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a valve, and timers are used to make the system function.

Oxygen is delivered to the patient on a continuous flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Oxlife Independence Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.

The design of the Oxlife Independence Oxygen Concentrator has focused on maximizing efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.

The basic technology of the Oxife Independence Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.

The provided text describes a 510(k) submission for the Oxlife Independence Oxygen Concentrator, seeking substantial equivalency to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a large-scale clinical study in the way an AI/ML device submission might.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to this documentation. The information provided is primarily related to bench testing for performance specifications and comparison to the predicate device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text refers to "the modified devices" and "bench top performance testing." This suggests laboratory testing on a sample of manufactured devices, but the exact number isn't specified.
• Data Provenance: The testing was "bench top performance testing," meaning it was conducted in a laboratory or engineering setting by the manufacturer (OxLife LLC). It is retrospective in the sense that it's testing a finished product against pre-defined engineering and performance specifications, but it's not a clinical study on patient data. Country of origin for data is not explicitly mentioned but implied to be where the company is located (USA).

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

• Not Applicable. For a device like an oxygen concentrator, "ground truth" as it relates to expert consensus or clinical outcomes isn't typically established in the same way as for diagnostic AI. The performance criteria are objective engineering specifications (e.g., oxygen concentration, power output). The "truth" is whether the device physically meets these measurable parameters.

4. Adjudication Method for the Test Set

• Not Applicable. Since the testing involves objective measurement of physical parameters, there is no need for human adjudication of results in the traditional sense of clinical or image interpretation studies. The measurements are taken by instruments.

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. An MRMC study is not relevant for an oxygen concentrator. This type of study is specific to diagnostic imaging or AI-assisted interpretation where human readers are making assessments.

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

• Not Applicable. The Oxlife Independence Oxygen Concentrator is a physical medical device, not an AI algorithm. Its performance is measured directly, not through an algorithm's output.

7. The Type of Ground Truth Used

• Objective Engineering Specifications/Measurements: The 'ground truth' for this device's performance is based on measurable, objective physical and chemical parameters related to its function, such as the actual concentration of oxygen produced, power consumption, and flow rates. These are compared directly to the target specifications of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As above, no training set is involved.

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The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purified oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. All models have inverter capability to use a 12 Volt DC power as well as 110v.

Here's an analysis of the provided text regarding the OxLife Freedom Five™ Oxygen Concentrators, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It simply states "the results of the oxygen concentration testing confirm..." without detailing the methodology or scope of this testing.

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

The document does not provide any information about experts used to establish ground truth or their qualifications. The testing appears to be based on objective measurements against specifications rather than expert interpretation.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The performance testing is presented as a direct measurement against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. The device in question is an oxygen concentrator, which delivers oxygen, and its performance is evaluated based on its ability to meet specific oxygen concentration and power delivery parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

The concept of "standalone" performance (algorithm only) as typically applied to AI/software is not directly applicable to this device. The device itself performs the function (generating oxygen). The performance data relates to the device's physical output and operational characteristics, not an algorithm's diagnostic accuracy. However, if interpreting "standalone" as the device operating independently to meet its specifications, then yes, the testing would evaluate the device's operational performance in generating oxygen at specified concentrations, without human intervention in the oxygen generation process itself.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective specifications for oxygen concentration and power delivery. For example, the device must produce "approximately 93% oxygen." This is a measurable physical property rather than an expert consensus, pathology, or outcomes data in the typical sense of medical diagnostic devices.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. This is a hardware device, and the concept of "training set" as used in machine learning (for an AI algorithm) is not relevant here. The device's design and manufacturing process would be subject to quality control, but not "training" in the AI sense.

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

As there is no mention of a "training set" in the context of AI, this question is not applicable. The device's operating principles are based on established physical and chemical processes (molecular sieve material) and engineering design, not learned from a dataset.

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