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The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow or in pulse mode, an oxygen bolus. The eQuinox Oxygen System is based on pressure swing adsorption (PSA) principles. The eQuinox Oxygen System operates from AC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start of inhalation is detected. The eQuinox Oxygen System consists of pneumatic and electrical components, AC power supply, DC cable and lithium ion batteries. The system has inlet filtration, air compressor, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.

AI/ML Overview

This document is a 510(k) summary for the eQuinox Oxygen System, which is an oxygen concentrator. The device is being submitted for substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Predicate Device K013931 / K083163)	Reported Device Performance (eQuinox Oxygen System)
Purity (Oxygen Concentration)	90 ± 3% at all flow rates
1.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163)	90 ± 3% (Continuous Flow: 1.0, 2.0, 3.0 LPM)
2.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163)	90 ± 3% (Pulse Mode: 16mL, 32mL, 48mL, 64mL, 80mL, 96mL, 128mL, 160mL, 192mL)
3.0 LPM Continuous: 90 ± 3% (K013931), 93 ± 3% (K083163)
Pulse Mode (various mL): 90 ± 3% (K013931), 93 ± 3% (K083163)
Physical Characteristics (Comparison to predicate devices, not explicit acceptance criteria)
Weight: 17.9 lbs (K013931), 10 lbs (K083163)	12 lbs
Width: 12.3" (K013931), - (K083163)	10.8"
Depth: 7.1" (K013931), - (K083163)	7.3"
Height: 19.3" (K013931), 26" (K083163)	15.5"
Other Performance Characteristics (All predicate devices: K013931, K083163)
Output Pressure: 5.0 psig nominal	5.0 psig nominal
High Compressor Pressure Relief: > 15 psig	> 15 psig
Oxygen Concentration Warning: 70 – 85 %	70 – 85 %
Oxygen Concentration Low: < 70%	< 70%
Alarms: Loss of Power, Low Oxygen Concentration, O2 Flow High or Low, No Inspiratory Detect in Pulse Mode, Low Power Cartridge, Unit Malfunction	Same features
Visual Indicators: Red LED for high priority, Yellow LED for low/medium priority, Green for system function	Same features

Note: The document explicitly states that "Performance testing demonstrates that the eQuinox Oxygen System is compliant with ISO 8359 standard for Oxygen Concentrators." This standard would contain the detailed acceptance criteria which are summarized in the table above based on the comparative data provided. The specific numerical values for oxygen concentration (90 ± 3%) are presented as the device's technical specifications and implicitly serve as the acceptance criteria for the purpose of demonstrating substantial equivalence to the predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a distinct sample size for a "test set" in the context of typical clinical evaluations. The performance data discussed relates to the device's inherent functional characteristics (e.g., oxygen concentration, electrical safety). It's implied that various units of the eQuinox Oxygen System were tested to confirm these specifications.
Data Provenance: The data is primarily from in-house performance testing conducted by the manufacturer, Chart SeQual Technologies Inc. The document does not mention data from external clinical studies or specific countries of origin for the data. The testing is retrospective in the sense that it was performed on pre-manufactured devices to verify their compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance data relates to objective physical and electrical measurements of the device's function, not interpretations by medical experts.

4. Adjudication method for the test set:

This information is not provided as the performance testing involves objective measurements against established engineering and medical device standards (ISO 8359, IEC 60601-1, IEC 60601-1-2), rather than subjective interpretations 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 device is an oxygen concentrator, not an AI-powered diagnostic tool requiring human interpretation enhancements.

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

This question is not applicable as the device is hardware-based for oxygen delivery and does not involve an algorithm for diagnostic or interpretative purposes.

7. The type of ground truth used:

The "ground truth" for the performance data is based on objective measurements against established international standards for oxygen concentrators (ISO 8359), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). For example, a gas analyzer would be used to objectively measure oxygen concentration, and electrical testing equipment would measure power consumption and safety parameters.

8. The sample size for the training set:

This information is not applicable. The eQuinox Oxygen System is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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