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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.

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

• Sample Size for Test Set:
  • Bench Testing: "Functional Performance Testing has been performed on a production unit" (singular unit).
  • Usability Testing: "Usability testing was performed with 4 users on two devices, lay users and Healthcare Providers."
  • Biocompatibility/Gas/Particulate Testing: The language ("the POC emitted a mean PM2.5 level") suggests measurements were taken, but the specific number of devices or samples tested for these parameters is not explicitly stated. It refers to "the GCE Zen-O™ POC" as a singular product.
• Data Provenance: Not specified, but generally, such bench and usability testing would be conducted in the country of manufacture or the submitting entity (likely US/UK given the "Oxus" name and regulatory context implied by FDA submission). These are prospective tests on the manufactured device.

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 / Not specified. For this type of device (portable oxygen concentrator), "ground truth" is established through physical measurements against engineering specifications and recognized performance standards, rather than expert interpretation of data. Usability testing involved "lay users and Healthcare Providers", but their qualifications beyond being "Healthcare Providers" are not detailed, and they are testing usability, not establishing a medical "ground truth."

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

• Not applicable / None. Adjudication methods are typically relevant for studies involving subjective interpretation (e.g., image-based diagnostics where multiple experts might disagree). This document describes objective bench and functional testing. Usability testing would involve observing user interaction, not adjudication in the medical "ground truth" sense.

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 is a physical medical device (oxygen concentrator), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This phrase is typically used for AI/software algorithms. For a physical device, its "standalone" performance refers to its functional performance as measured in lab conditions, which was done via "Functional Performance Testing on a production unit."

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

• The "ground truth" for this device's performance is based on:
  • Engineering specifications and design requirements: How the device should perform according to its design.
  • Recognized consensus standards: International (e.g., ISO, IEC) and national (e.g., AAMI ANSI) standards that specify performance and safety requirements for such devices (e.g., oxygen concentration, electrical safety, EMC, acoustic noise).
  • Predicate device performance: The performance of the legally marketed predicate device (K073242 RS-00400) provides a benchmark for substantial equivalence.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

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

• Not applicable. As there is no training set, this question is not relevant.

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