(506 days)
This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
The Yuyue Oxygen Concentrator models 8F-3A/8F-5A is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The subject device is intended use for adult population.
The subject device contains primary electrical components including main unit, compressor, fan, flowmeter and circuit breaker, the software is moderate level according to FDA software guideline.
This submission is for an Oxygen Concentrator, models 8F-3A and 8F-5A. The provided document does not contain information related to a study that proves the device meets acceptance criteria in the context of AI/ML performance, human-in-the-loop studies, or expert ground truth adjudication.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (L4 Oxygen Concentrator (EverFlo), K061261) through non-clinical performance data for regulatory clearance. This involves comparing technical specifications and performance against recognized standards, rather than evaluating AI performance with acceptance criteria typically found in machine learning contexts.
Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table for substantial equivalence, which includes various technical characteristics and a comparison to the predicate device. These characteristics serve as "acceptance criteria" for showing equivalence to the predicate, rather than explicit performance metrics against a defined threshold specific to a new AI/ML device.
| Characteristic | Acceptance Criteria (Subject Device Performance) | Predicate Device Performance K061261 | Comparison |
|---|---|---|---|
| Oxygen Concentration | (8F-3A): ≥90%; | ||
| (8F-5A): 95.5%-87% | 90-96% from 1 to 5 LPM | Equivalent | |
| Flow Rate | (8F-3A): 1-3 LPM; | ||
| (8F-5A): 1-5 LPM | from 1 to 5 LPM | Equivalent | |
| Output Pressure | ≤70 kPa | 44.8 kPa (6.5PSIG) | Equivalent |
| IP classification | IP21 | IP21 | Same |
| Complies with ISO 10993-1 | Yes | Yes | Same |
| Complies with ISO 80601-2-69 | Yes | Yes | Same |
| Complies with ASTM D4169-16 | Yes | Yes | Same |
| Complies with ES 60601-1 Electrical Safety | Yes | Yes | Same |
| Complies with IEC 60601-1-2 EMC Safety | Yes | Yes | Same |
| Indication for Use | This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining. | The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment. | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The provided document details non-clinical laboratory testing and compliance with various standards, not performance results from a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is not relevant to this type of device and submission, which focuses on hardware performance and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant to this type of device and submission.
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 an oxygen concentrator, not an AI/ML-driven diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for AI/ML performance is not relevant here. The "ground truth" for this device's performance is its ability to meet the specified technical parameters (e.g., oxygen concentration, flow rate) and safety standards through physical testing and engineering measurements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).