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Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.

The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.

The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen.

These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.

The provided text describes a 510(k) premarket notification for a medical device: a Refurbished Replacement Column (Sieve Bed) for the Inogen One G3 Oxygen Concentrator. However, the document does not contain information related to an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth establishment for such an AI/ML device.

The document outlines acceptance criteria and performance testing for a refurbished physical component (sieve bed), not an AI model. Therefore, I cannot extract the information required for the questions regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies.

Here's an attempt to answer the questions based only on the information present in the provided document, highlighting where the information is not applicable (N/A) because it pertains to an AI/ML study, not a physical device performance study.

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

The document lists performance tests and acceptance criteria in a descriptive manner, not in a formal table with reported numeric results for each criterion. It generally states that the device "met its acceptance criteria" and provides some of the criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the "test set" (which refers to physical units of the sieve bed for testing). It also does not mention data provenance (country, retrospective/prospective), as this is not typical for testing of a physical medical device component like a sieve bed. The tests appear to be bench tests conducted on the physical device itself.

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)

N/A. This pertains to AI/ML model validation, where human experts establish ground truth for AI model performance evaluation. For a physical device component, "ground truth" is established by direct physical or chemical measurements and adherence to engineering specifications and international standards (e.g., ISO). No human experts were involved in "establishing ground truth" in the context of an AI model's output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used in AI/ML validation studies to resolve disagreements among human readers or experts when establishing ground truth. This is not relevant for the bench testing of a physical device.

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

N/A. No MRMC study was conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a refurbished oxygen concentrator component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. There is no AI algorithm involved in this device. Performance testing was conducted on the physical sieve bed component in isolation within an oxygen concentrator system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" is based on:

• Physical/Chemical measurements and adherence to specifications: e.g., fill volume, leakage rates, oxygen purity percentage.
• Compliance with international standards: e.g., ISO 80601-2-69:2020 for oxygen purity, ISO 18562 for biocompatibility (particulate matter, VOCs, inorganic gases).
• Comparison to predicate device performance: The refurbished sieve bed's performance was compared directly to that of the original Inogen One G3 replacement sieve bed cartridge.

8. The sample size for the training set

N/A. There is no AI/ML model, and therefore no training set.

9. How the ground truth for the training set was established

N/A. There is no AI/ML model, and therefore no training set or ground truth establishment process for a training set.

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