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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.

AI/ML Overview

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.

Attribute	Predicate Device (K073242 RS-00400) Reported Performance/Specification	Proposed Device (GCE Zen-O™ RS-00500) Reported Performance/Specification	Underlying "Acceptance Criteria" (Implied)
Indications for Use	Provides supplemental oxygen in home, institutional, or travel environment.	Provides supplemental oxygen in home, institutional, or travel environment.	Equivalent to predicate.
Environments of Use	Travel, Home or Institution	Travel, Home or Institution	Equivalent to predicate.
Prescriptive	Yes	Yes	Equivalent to predicate.
Patient Population	Adult	Adult	Equivalent to predicate.
Single Patient, multi-use	Yes	Yes	Equivalent to predicate.
Patient Interface	Cannula port	Cannula port	Equivalent to predicate.
Technology	Pressure Swing Adsorption with molecular sieve	Pressure Swing Adsorption with molecular sieve	Equivalent to predicate, "oxygen producing operations are similar".
Dimensions	4.6" H x 7.5" W x 11.6" L	6.6" H x 8.3" W x 12.3" L	Within acceptable variations for a similar device.
Weight	10 lbs	10.25 lbs	Within acceptable variations for a similar device.
Oxygen Concentration	87% - 96%	87% - 96%	87% - 96% oxygen concentration (matching predicate).
Equivalent Flow Rates	1-5 LPM, increments of 0.5 LPM	1-6 LPM, increments of 0.5 LPM (pulse)
0.5 - 2 LPM, increments of 0.5 L (continuous)	Acceptable range and increments, including additional continuous mode.
Dose at Specified Flow	8.5 mL per setting	11 mL per setting	Within acceptable physiological range for oxygen delivery.
Filters	Input, Intermediate, Patient Filter	Input, Patient Filter	Appropriate filtration for oxygen delivery.
User Interface	Buttons, LCD Display	Buttons, LCD Display	Equivalent to predicate.
Electrical	100-240VAC, 50/60 Hz, 1.6A; 18VDC, 7A	100-240VAC, 50/60 Hz, 2.5A; 24VDC, 6.25A	Meets electrical safety standards (IEC 60601-1, etc.).
Software	Embedded	Embedded	Software verification and validation conducted (moderate level of concern).
Acoustic Noise	42 dBA at 2 LPM	42 dBA at 2 LPM	42 dBA at 2 LPM (matching predicate).
Alarms	Various (Battery empty, Low Pressure, No pulse, High temp, etc.)	Various (Battery empty, Low Pressure, Motor communication, No pulse, etc.)	Comprehensive alarm system for safety and functionality.
Status Indicators	Flowrates, Battery Condition, Alarms, History Log, Diagnostics	Flowrates, Battery Condition, Alarms, History Log, Diagnostics	Equivalent to predicate for user information.
Battery Duration	Approximately 4 hours at 2LPM (pulse)	Approximately 4 hours at 2LPM (pulse)	Approximately 4 hours at 2LPM (pulse) (matching predicate).
Operating Environment	5 to 40° C; Altitude: 0-8000 ft; RH: 5 - 95 %	5 to 40° C; Altitude: 0-9000 ft; RH: 5 - 93 %	Within acceptable environmental operational conditions.
Shipping / Storage Conditions	Temperature: -20 to 60°C; Humidity: 0 - 95 % RH	Temperature: -20 to 60°C; Humidity: 0 - 93 % RH	Within acceptable environmental storage/shipping conditions.
Safety	IEC 60601-1-2	IEC 60601-1; IEC 60601-1-2	Compliance with relevant IEC standards.
Mechanical Safety	IEC 60601-1	IEC 60601-1	Compliance with IEC 60601-1.
Chemical Safety	Not Applicable	Not Applicable	N/A.
Thermal Safety	IEC 60601-1	IEC 60601-1	Compliance with IEC 60601-1.
Biocompatibility	4 VOC's less than ambient	4 VOC's less than ambient	PM2.5 less than EPA limit; Ozone

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