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

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 purfied 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 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.
The major change to the device has been the reduction in the size of the molecular sieve tanks and subsequent volume of sieve material. This change allowed the elimination of the crossover valve and required a reduction of the cycle time.
A separate change to be implemented is the addition of an optional, larger inverter capable of operating the 6 LPM models using 12 Volt DC power. Currently, these models are specifically excluded from 12 volt use due to their large power draw.

The provided text describes modifications to an oxygen concentrator and its substantial equivalence to a predicate device. It does not contain information about a study that would involve acceptance criteria, test sets, ground truth, or expert involvement as typically seen in AI/ML device evaluations. The document is a 510(k) summary for a physical medical device, not an AI/ML algorithm.

Therefore, most of the requested information cannot be extracted from the provided text.

However, I can provide the limited information that exists concerning performance and equivalence.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes performance testing for a physical oxygen concentrator, not an AI/ML algorithm trained or tested on data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" here refers to the device's physical performance, not clinical diagnoses or interpretations by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or disagreements 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
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm described for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on the physical specifications and performance of the oxygen concentrator, primarily the oxygen concentration output and power capabilities, confirmed through "oxygen concentration testing".

8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.

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The OxLife oxygen concentrators are intended to provide 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 or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device works by filtering room air into a holding tank. The air is then flushed through two aluminum welded molecular sieve tanks in series. The molecular sieve material absorbs nitrogen which comprises approximately 78% of the makeup of the room air. The resulting gas is approximately 93% oxygen.
This modification is designed to increase the output of the device to enable an oxygen flow of uc to 6 LPM at 93% ± 3% purity. The device will be marketed with several options to provide the most marketing flexibility. One set of devices will be marketed with a single oxygen outlet through a single flow meter. The others will be marketed with two oxygen outlets, each with it's own regulator and flow meter. The single outlet devices will be sold with a 5 LPM (L-5) model or 6 LPM (L-6) model with a 5 LPM or 6 LPM flow meter respectively. The dual outlet device (DL-3) will be marketed with two 6 LPM flow meters. This device is designed to provide for the needs of two patients in any combination of flows up to 6 LPM. The major change to the device has been the replacement of the single-headed Thomas WOB-L compressor with a dual-headed Thomas WOB-L compressor. This doubled the output to 3 CFM, facilitating the increased oxygen flow.

The provided text describes a medical device modification (K955549 for OxLife Oxygen Concentrators) and its comparison to a predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, expert opinions, or the methodologies typically associated with assessing AI or diagnostic device performance.

The document focuses on:

• Device Description: How the oxygen concentrator works (filtering air, using molecular sieves to absorb nitrogen) and the specific modifications made (upgraded compressor, increased circuit breaker).
• Performance Specifications: Increased oxygen flow rate (up to 6 LPM) and maintained oxygen concentration accuracy (93% +/- 3% for flows > 2 LPM).
• Comparison to Predicate: Asserting substantial equivalence to an existing device (K933081) based on design, performance specifications, and intended use.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study or performance validation against explicit acceptance criteria in the manner you've outlined. This type of submission often relies on engineering and functional testing data to show that the modified device performs as intended and is as safe and effective as the predicate.

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