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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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The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is intended for the administration of supplemental oxygen up to 10 LPM. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, is a 0.5 to 10.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen.

The SeQual Model 6323A-OM-10, Integra Oxygen Concentrator, consists of pneumatic and electrical components. The system has inlet filtration, air compressors, heat exchanger, and Synthetic Zeolite molecular sieve beds with a rotary valve, outlet filtration, electronic flow control and audible / visual alarms.

The provided document is a 510(k) summary for the SeQual Model 6323A-OM-10, Integra Oxygen Concentrator. This document describes a medical device for oxygen delivery and its equivalence to predicate devices, not an AI/ML powered device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to this type of submission.

However, I can extract information related to the device's acceptance criteria and the study proving it meets them.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "meets specifications" without detailing the specific percentage of oxygen concentration required by ISO 8359 and ASTM 1464. These standards define requirements for oxygen concentrators, including oxygen purity.

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

Not applicable for this type of device and submission. The performance data focuses on device specifications rather than clinical data from a "test set" in the context of an AI/ML evaluation. The “test set” here refers to the device itself being tested for its functional specifications.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for an oxygen concentrator's performance evaluation. The "ground truth" here is the physical measurement of oxygen concentration against established engineering standards.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). The performance of an oxygen concentrator is measured objectively.

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

Not applicable. This is not an AI/ML-powered device.

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

Not applicable. This is not an AI/ML-powered device.

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

The ground truth for evaluating the device's performance is based on objective measurements against established international and national standards for oxygen concentrators (ISO 8359 and ASTM 1464). These standards define the acceptable range of oxygen concentration for such devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML-powered device.

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

Not applicable. This is not an AI/ML-powered device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study referenced is "oxygen concentration testing to ISO 8359 and ASTM 1464 standards." These are internationally recognized standards for oxygen concentrators. The document states that these tests "confirm the device meets specifications and is substantially equivalent to the predicate devices." This implies that the device underwent testing to verify its ability to produce oxygen within the purity and flow specifications outlined by these standards at various operational parameters (e.g., flow rates, as the device is specified for 0.5 to 10.0 LPM). The details of the specific tests performed (e.g., number of units tested, environmental conditions, duration of tests) are not provided in this 510(k) summary, but the reference to these standards indicates the methodology.

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The Model 1000 Omni Oxygen System is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The SeQual Model Number 1000 OMNI Portable Oxygen Concentrator is a 3 Liter per minute (LPM) continuous flow and 6 LPM demand flow oxygen concentrator that is of the pressure swing adsorption (PSA) type. The OMNI Portable Oxygen Concentrator 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 a demand flow mode. During the demand flow mode, oxygen is delivered to the patient through a demand flow valve when the start of inhalation is detected. The Model Number 1000, OMNI Portable Oxygen System consists of pneumatic and electrical components. The system has 5 major pneumatic components: inlet filtration, air compressor and heat exchanger, Synthetic Zeolite molecular sieve beds with a distribution valve module, outlet filtration, and flow delivery and measurement components. The electrical system consists of: motor controls, power sources for AC and DC power, rechargeable batteries, sensing systems to measure pressure, temperature, flow and oxygen concentration, and a software controlled user interface. The unit is double insulated and uses a two-conductor power cable. In the event of a malfunction, the unit will activate visual and audio alarms and if, necessary, shut down. Device monitoring circuits are included to measure oxygen concentration, flow rates, battery capacity and internal temperatures.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The document is a 510(k) premarket notification for the SeQual Model 1000 OMNI Portable Oxygen Concentrator. It aims to demonstrate substantial equivalence to previously marketed devices. However, it's important to note that this document does not detail specific acceptance criteria with numerical targets and corresponding measured device performance in a table format, nor does it describe a detailed clinical study with human subjects validating the device against specific ground truth.

Instead, the submission relies on technical specifications, bench testing, and comparison to predicate devices to assert substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "thorough series of testing" and "oxygen concentration testing" using the device itself, not a dataset of patient data.
• Data Provenance: Not applicable. The testing appears to be primarily laboratory/bench testing of the device's technical specifications and electrical safety, not clinical data from patients.

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

• Not applicable. Ground truth, in the context of clinical expert consensus for AI/diagnostic devices, is not relevant here as this is a physical medical device (oxygen concentrator) and the testing described is primarily bench testing for functionality and safety, not a diagnostic task.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of adjudication, as there isn't a complex diagnostic outcome requiring multiple expert opinions.

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

• No. The document describes technical testing of the device's physical and functional characteristics, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.

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

• Not applicable. This device is an oxygen concentrator, a physical medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and electrical design.

7. The Type of Ground Truth Used

• Device Specifications and Industry Standards: The "ground truth" for this type of device and submission is implicitly its own stated technical specifications (e.g., flow rate, oxygen concentration) and adherence to recognized industry standards (ISO 8359, ASTM F1464).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not applicable, as there is no training set.

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