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The SeQual Model T2000 Series, MESA II 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 device has no contraindications.
The MESA II Oxygen Concentrator (Model No.: T2000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

The SeQual Model T2000 Series, MESA II 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 T2000 Series, MESA II 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 SeQual MESA II Oxygen Concentrator (Model T2000 Series) undergoes performance testing to confirm its specifications and demonstrate substantial equivalence to predicate devices, as per the ISO 8359 and ASTM 1464 standards. The key performance metric is oxygen concentration, measured at various flow rates.

1. Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are based on the performance ranges of the predicate devices. The MESA II's reported performance falls within or matches these established ranges.

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

The document does not specify the exact sample size used for the oxygen concentration testing. However, it indicates compliance with ISO 8359 (Oxygen concentrators for medical use — Safety requirements) and ASTM 1464 (Standard Practice for Oxygen Concentrators for Medical Use). These international standards prescribe methodologies for testing medical devices, which typically involve testing multiple units to ensure reliability and reproducibility.

The data provenance is not explicitly stated as "retrospective" or "prospective." Given that these are performance tests of a manufactured device against established standards, they are inherently prospective in nature, conducted on new or production units of the MESA II Oxygen Concentrator by the manufacturer, SeQual Technologies Co., Ltd. The country of origin for the data generation would be Taiwan (R.O.C.), where the submitter SeQual Technologies Co., Ltd is located.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The study described is a performance validation of a physical medical device (oxygen concentrator) against technical standards (ISO 8359 and ASTM 1464) for oxygen output. It does not involve human interpretation of data (e.g., medical images) where expert ground truth would be required. The "ground truth" here is the result of direct physical measurement of oxygen concentration by calibrated instruments.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human reviewers provide subjective assessments that need to be reconciled, such as in clinical trials involving image interpretation. For device performance testing, objective measurements are taken, and results are compared directly to defined specification limits.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI systems on human performance, particularly in diagnostic tasks. The device in question is an oxygen concentrator, which is a therapeutic device, and its performance is assessed directly through physical measurements, not through human interpretation or AI assistance.

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

Yes, a standalone performance assessment was done. The "Performance Data" section explicitly states: "Results of the oxygen concentraton testing to ISO 8359 and ASTM 1464 standards confirm the device meets specifications..." This indicates that the device's performance (oxygen concentration output) was measured directly and objectively, without human intervention or interpretation influencing the output, and then compared to the specified criteria. This is a standalone assessment of the device's functional performance.

7. The Type of Ground Truth Used

The ground truth used is objective physical measurement of oxygen concentration. This is established by laboratory testing using calibrated equipment that measures the percentage of oxygen produced by the concentrator at various flow rates. These measurements are then compared against the specified performance ranges defined by the ISO 8359 and ASTM 1464 standards, and critically, against the performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The MESA II Oxygen Concentrator is a physical medical device that operates based on established engineering principles (Pressure Swing Adsorption). Its design and functionality do not involve machine learning algorithms or AI models that require a "training set" of data.

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

This information is not applicable, as there is no training set involved for this device.

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The MESA Oxygen Concentrator (Model No .: 2-6000 Series) is intended to provide supplemental oxygen. It is not intended for life supporting, or life sustaining applications nor does it provide any patient monitoring capabilities.

The SeQual Model 2-6000 Series, MESA Oxygen Concentrator, is a 0.5 to 5.0 Liter per minute (LPM) continuous flow pressure swing adsorption (PSA) type system that produces oxygen. The SeQual Model 2-6000 Series, MESA 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 510(k) summary for the SeQual MESA Oxygen Concentrator describes a medical device, not an AI/ML software. Therefore, the questions related to AI/ML specific criteria like ground truth, experts, adjudication, MRMC studies, and sample sizes for training/test sets are not applicable to this submission.

The acceptance criteria and study described are for a traditional medical device demonstrating substantial equivalence to predicates based on performance specifications.

Here's the information extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for performance testing. Medical device testing for physical devices typically involves engineering verification and validation, which might use a small number of units for testing to standards.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The device itself is manufactured by SeQual Technologies Co., Ltd in Taipei, Taiwan. The performance testing refers to international and US standards (ISO 8359 and ASTM 1464).

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

• Not Applicable. This is a physical medical device, not an AI/ML software requiring expert-established ground truth. Performance is assessed against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a physical device, there is no "adjudication" of expert opinions. Performance is measured objectively against defined technical standards.

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 device is a physical oxygen concentrator, not an AI/ML software designed to assist human readers.

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

• Not Applicable. This device is a physical medical device; there is no algorithm in the AI/ML sense to test in "standalone" mode.

7. The Type of Ground Truth Used

• Not Applicable. For this physical device, "ground truth" refers to objective measurements of oxygen concentration and flow rate, validated against established industry standards (ISO 8359 and ASTM 1464) and the device's own specifications. It is not an expert consensus, pathology, or outcomes data in the context of an AI/ML diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML model that is "trained." The "design" and "performance specifications" are developed through engineering and manufacturing processes, not machine learning training.

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

• Not Applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment methodology.

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