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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.

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The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

The GCE Zen-O™ (Model RS-00500) POC is the latest design of POC from Oxus, Inc. The GCE Zen-O™ POC delivers 87% - 96% oxygen to a patient through a standard singlelumen nasal cannula. The GCE Zen-O™ POC detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period (pulse mode) or can provide a continuous flow of oxygen (continuous mode). The device is portable, enabling patients who need an oxygen device to be treated at home according to a clinician's prescription or direction. The GCE Zen-O™ POC can be set to deliver flowrates between 1-6 LPM in pulse mode and 0.5-2 LPM in continuous mode; both with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.

The provided text is a 510(k) Summary for a GCE Zen-O™ Portable Oxygen Concentrator Model RS-00500 (K162433). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Oxus, RS-00400 Portable Oxygen Concentrator, K073242), rather than detailing specific acceptance criteria and a comprehensive study for meeting them in the way one might expect for a novel or high-risk device.

Therefore, the information requested in the prompt, especially regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training sets, is not explicitly available in this type of regulatory submission. The submission relies on comparative bench testing and compliance with recognized standards.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document focuses on comparing attributes to a predicate device (Oxus, RS-00400, K073242) and meeting recognized standards, rather than setting explicit acceptance criteria with specific performance metrics for this particular device in a tabular format. The "performance" is largely demonstrated by meeting these standards and showing equivalence to the predicate.

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