Search Results

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.

Ask a specific question about this device