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The OMNI 2 Oxygen System is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The OMNI 2 Oxygen System is an oxygen concentrator that provides up to 3 LPM continuous flow or in pulse mode an oxygen bolus of up to 96 mL (milli-Liter). The OMNI 2 Oxygen System is based on pressure swing adsorption (PSA) principles. The OMNI 2 Oxygen System operates from AC power, DC 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 if inhalation is detected.
The OMNI 2 Oxygen System consists of pneumatic and electrical components, AC power supplies, DC cables and lithium ion batteries. The system has inlet filtration, air compressors, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.

The SeQual Technologies OMNI 2 Oxygen System 510(k) submission (K083163) provides a summary of performance data indicating compliance with relevant standards. However, it does not contain the level of detail typically found in studies designed to robustly prove device performance against specific acceptance criteria for AI/diagnostic devices.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Missing Information & General Notes:

• This is not an AI/Diagnostic Device: The OMNI 2 Oxygen System is an oxygen concentrator. The submission focuses on hardware performance, electrical safety, and environmental compliance, not diagnostic accuracy or AI performance. Therefore, many of the requested categories (e.g., ground truth, reader studies, effect size of AI, etc.) are not applicable to this type of device.
• Focus on Substantial Equivalence: This 510(k) is aimed at demonstrating substantial equivalence to a legally marketed predicate device (K013931 - OMNI Oxygen System, Model 1000). The performance data presented is to show the new device is as safe and effective as the predicate, not necessarily to break new ground in performance or achieve specific clinical outcomes.
• Summary Level Data: 510(k) summaries often provide high-level statements about testing rather than detailed experimental protocols and results.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is an oxygen concentrator, the "acceptance criteria" are related to engineering specifications and compliance with device standards, rather than diagnostic accuracy metrics. The document broadly states compliance with standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the summary. For an oxygen concentrator, the "test set" would typically refer to a number of manufactured units subjected to various performance, environmental, and electrical tests. The summary does not disclose how many units were tested.
• Data Provenance: Not explicitly stated as retrospective or prospective for the various tests. Given the nature of device testing for regulatory submission, it is assumed to be prospective testing conducted on pre-production or production units. The country of origin for the data is implicitly the USA, where SeQual Technologies is located and where the testing was likely overseen, though third-party testing labs could be anywhere.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. This device is an oxygen concentrator, not an AI or diagnostic device that relies on expert interpretation of images or other data to establish a "ground truth." Its performance is measured against engineering specifications and objective physical/electrical parameters.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not relevant to the engineering performance testing of an oxygen concentrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, in diagnostic tasks. This is not relevant for an oxygen concentrator.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not Applicable. Standalone algorithm performance refers to the performance of an AI model without human intervention. The OMNI 2 Oxygen System does not incorporate an AI algorithm for diagnostic or clinical decision-making purposes. Its "performance" is its ability to produce oxygen according to specifications, which is inherently a standalone device function.

7. The Type of Ground Truth Used

Not Applicable. For this device, "ground truth" would be the objective physical and chemical properties measured during testing (e.g., oxygen concentration, flow rate, pressure, power consumption, electrical safety parameters) and compliance with specified environmental conditions. It is not an expert consensus, pathology, or outcomes data in the sense used for diagnostic devices.

8. The Sample Size for the Training Set

Not Applicable. This device uses established PSA technology and does not involve machine learning or AI models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI model, this question is not relevant.

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