(90 days)
HG Oxygen concentrator is intended to provide supplemental oxygen to patient continuously in home, hospital or health care facility environments. It is not for supporting or sustaining life.
The subject device, HG Oxygen Concentrator, contains two models, HG5-W and HG5-WN. These two models follow the same design principle, same raw material, same main function and same specification. The only difference between the two models is that HG5-WN oxygen concentrator provide an addition interface on the front panel, which can be connected to the nebulizer and supply air to the nebulizer.
The subject device, HG Oxygen Concentrator, is intend to provide ≥90% supplemental low flow oxygen, which is separated from the room air, to the patient in the home, nursing homes, patient care facilities, etc. Oxygen is delivered to the patient via a nasal cannula or oxygen mask, but these accessories are not supplied with the concentrator, the user shall select appropriate and legally marketed accessories themselves. The subject device is not intended to support or sustain life.
The subject device, HG Oxygen Concentrator, uses Pressure Swing Adsorption technology to deliver concentrated oxygen. Two chambers and a valve allow compressed air to enter the embedded sieve, which will separate the nitrogen from the air. When one chamber is receiving compressed air, the other is expelling nitrogen back to the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in an oxygen store cylinder to be delivered to a patient. This working principle is widely used in the oxygen concentrator, it will not arise new question of safety and effectiveness.
The provided text is a 510(k) summary for the HG Oxygen Concentrator and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating that the device meets those criteria. The document states that "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications and was substantially equivalent to the predicate device," but it does not provide the specifics of those design specifications or the results of the laboratory testing with numerical data.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the limited information available and explicitly stating what cannot be found:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Provide ≥90% supplemental low flow oxygen | Subject device is intended to provide ≥90% supplemental low flow oxygen (This is an intended performance, not a reported measured performance from a study in this document). |
| Substantially equivalent to predicate device (Delphi Portable Oxygen Concentrator K073242) | Stated as "Substantially Equivalent Conclusion: The subject device, HG Oxygen Concentrator, is substantially equivalent to the predicate device." |
| Meeting all design specifications | Stated as "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications." (No specific design specifications or results are provided). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but "Laboratory testing was conducted" implies it was likely internal testing by Shenyang Canta Medical TECH. Co., Ltd. Given the company's location in China, the testing likely occurred there. It would be prospective testing as it relates to validating new design specifications.
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. This device is an oxygen concentrator, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the context of radiologists, pathology, etc. Its performance evaluation would involve instrumental measurements of oxygen concentration, flow rates, etc.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and the information provided. Adjudication methods like 2+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation.
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; it does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is typically relevant for AI algorithms. For an oxygen concentrator, the "standalone" performance would refer to the device's functional operation in terms of oxygen output, purity, and flow rates. The document indicates that "Laboratory testing was conducted to validate and verify that HG Oxygen Concentrator met all design specifications," which implies standalone testing of the device's technical performance. However, no specific details or results of this testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an oxygen concentrator, the "ground truth" would likely be based on objective physical measurements using calibrated equipment (e.g., oxygen analyzers) to confirm oxygen purity, flow rates, pressure, and other technical specifications against engineering standards. The document does not specify the exact methods or standards used.
8. The sample size for the training set
Not applicable. This device is hardware (an oxygen concentrator), not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is hardware (an oxygen concentrator), not a software algorithm that requires a training set and its associated ground truth establishment.
§ 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).