(219 days)
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
| Performance Standard/Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Oxygen Concentration | Meets specifications as per ISO 8359 and ASTM 1464 standards (required for predicate equivalence) | "confirm the device meets specifications" |
| Flow Rate Range | 0.5 to 5.0 Liters per minute (LPM) continuous flow (inherent to device description) | Described as a "0.5 to 5.0 Liter per minute (LPM) continuous flow" system |
| Intended Use | Administration of supplemental oxygen up to 5 LPM; NOT for life support or patient monitoring | Stated as the intended use; no contraindications |
| Technological Characteristics | Comparable to predicate devices, no new safety/effectiveness questions | "operates comparably to the listed predicate devices" |
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.
§ 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).