(241 days)
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
| Device Name | MESA II (10LPM) (Reported Performance) | Acceptance Criteria (Predicate: INTEGRA E-Z (10LPM) / RESPIRONICS M10 Concentrator) |
|---|---|---|
| Oxygen Concentration (OC) | ||
| 8-10 LPM | 91 ± 3 | 91 ± 3 / 92 ± 4 |
| 3-7 LPM | 94 ± 3 | 94 ± 3 / 94 ± 2 |
| 1-2 LPM | 94 ± 3 | 94 ± 3 / 92 ± 4 |
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.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).