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510(k) Data Aggregation
(141 days)
The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The Hygeia-5 Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device operates on the same pressure swing adsorption (PSA) principle as other oxygen concentrators. They use the same type of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. Most concentrators use two sieve beds, alternating between the beds using one bed to generate the oxygen while the other is flushed for regeneration. The Hygeia-5 differs in as much as it has 5 smaller beds instead of two large beds and uses a rotating valve to distribute the air to the sieve beds and control the cycle of the adsorption and regeneration. This concept/design is similar to the Sequal device. As with other concentrators, it has an Oxygen reservoir to collect the oxygen before distribution to the patient. The Oxygen concentrator is also equipped with electronic alarms to monitor for power failure and over or under pressure of the pneumatic system.
The provided text describes a 510(k) premarket notification for the Hygeia-5 Oxygen Concentrator, which is a medical device. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or algorithm performance study would.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabulated format. Instead, it relies on a statement of meeting specifications and substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide supplemental oxygen. | Meets the indication to "provide supplemental oxygen for adults requiring supplemental oxygen." |
| Technological Characteristics Equivalence: Operate on PSA principle, use molecular sieve material, have oxygen reservoir, and electronic alarms. | "The technological characteristics are the same as the predicate devices." |
| "Operates on the same pressure swing adsorption (PSA) principle." | |
| "Uses the same type of molecular sieve material." | |
| "Has 5 smaller beds instead of two large beds and uses a rotating valve... similar to the Sequal device." | |
| "Equipped with electronic alarms to monitor for power failure and over or under pressure." | |
| Safety and Effectiveness Equivalence: Comparable performance to legally marketed predicate devices. | "Verification testing has confirmed the product meets its specifications." |
| "Substantially equivalent to products currently legally marketed in the USA." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any sample size for a test set in the context of an AI/algorithm performance study. The "verification testing" mentioned is likely internal engineering validation, not a clinical trial with a specific patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission is for a physical medical device (oxygen concentrator), not an AI/algorithm requiring expert-annotated ground truth.
4. Adjudication Method for the Test Set
Not applicable for the reasons mentioned above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is not an AI/algorithm. The comparison is against predicate devices based on technological characteristics and functional equivalence, not human reader performance.
6. Standalone Performance Study
The document states, "Verification testing has confirmed the product meets its specifications." This refers to the standalone performance of the physical device against its design specifications, not an "algorithm only without human-in-the-loop performance" in the context of AI.
7. Type of Ground Truth Used
For a physical device like an oxygen concentrator, the "ground truth" would be established by:
- Engineering specifications and standards (e.g., oxygen concentration levels, flow rates, alarm functionality).
- Performance data demonstrating adherence to these specifications.
- Comparison to the established performance of predicate devices.
The document implies that the device's performance was measured against its internal specifications and deemed equivalent to predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm, so there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons mentioned above.
In summary, the provided text is a 510(k) summary for a physical medical device (oxygen concentrator). The "acceptance criteria" revolve around established safety and effectiveness standards for such devices and demonstrating substantial equivalence to already-marketed predicate devices. It does not contain information related to AI/algorithm performance, clinical study design, or ground truth establishment in the manner described by the detailed questions.
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