(296 days)
The Oxygen Concentrators with the Oxygen Filling accessory are indicated to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The Profill Q601 series oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.
The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile.
The provided document describes a K091716 submission for the Merits Health Products Profill Q601 Series Oxygen Filling Accessory. This device is subject to a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against detailed acceptance criteria through a clinical study in the way an AI diagnostic device would.
Therefore, many of the typical questions for AI device studies regarding acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable in this context. This submission relies on performance data from engineering tests and a comparison of technological characteristics to establish substantial equivalence.
Here's the breakdown of the information that can be extracted, and where typical AI study information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Safety Tests | Leakage Currents Test | Meets safety standards | Confirmed |
| Dielectric Strength | Meets safety standards | Confirmed | |
| Rigidity Test | Meets safety standards | Confirmed | |
| Stability Test | Meets safety standards | Confirmed | |
| Heating Test | Meets safety standards | Confirmed | |
| Abnormal Operation & Fault Condition | Meets safety standards | Confirmed | |
| Power Cord Test | Meets safety standards | Confirmed | |
| Transformer Dielectric Strength | Meets safety standards | Confirmed | |
| Ball Pressure Test | Meets safety standards | Confirmed | |
| Electromagnetic Compatibility (EMC) Tests | EN60601-1-2 | Meets EMC standards | Finished |
| EN61000-3-2 | Meets EMC standards | Finished | |
| EN61000-3-3 | Meets EMC standards | Finished | |
| Technological Characteristics | Oxygen Source | Same as predicate | Oxygen concentrator |
| AC-Powered Motors | Similar to predicate | Similar | |
| Oxygen Compressors | Same size & material as predicate | Same | |
| Filling Time | Same as predicate | Same | |
| Filling Pressure | Same as predicate | Same | |
| Safety & EMC Requirements | Same as predicate | Same |
Note: For 510(k) submissions, the "acceptance criteria" for these engineering tests are implicitly that the device meets the relevant industry performance and safety standards. The document states "Verification testing has confirmed the product meets its specifications," which indicates successful completion of these tests in accordance with established benchmarks for safety and functionality.
Regarding the study that proves the device meets the acceptance criteria (and other AI-specific questions):
For this type of device (an Oxygen Filling Accessory), the "study" proving it meets acceptance criteria is a series of engineering and safety tests, not a clinical study involving patients or human readers as would be typical for an AI diagnostic device.
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 (N/A). This device is an oxygen filling accessory, not an AI diagnostic tool. The performance data is based on engineering and safety tests of the device itself, not on a test set of patient data or images.
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 (N/A). Ground truth in the context of AI refers to expert labeling of data. For this device, "ground truth" relates to the physical and electrical safety standards that the device must meet, which are objectively measurable by testing engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). This pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.
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 (N/A). This type of study is for evaluating AI's impact on human performance in diagnostic tasks and is not relevant for an oxygen filling accessory.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This refers to the performance of an AI algorithm in isolation, which is not relevant for this device. The device's "performance" is its ability to safely and effectively pressurize oxygen and fill cylinders.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Engineering Standards and Safety Regulations. The "ground truth" for this device's performance is adherence to established international and national safety, electrical, and EMC standards (e.g., EN60601-1-2, EN61000-3-2, EN61000-3-3) and the device's functional specifications (filling time, pressure).
8. The sample size for the training set
- Not Applicable (N/A). This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not Applicable (N/A). As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary for a medical device that demonstrates substantial equivalence through technical comparisons and adherence to engineering safety standards, rather than clinical efficacy studies often associated with AI diagnostic tools.
§ 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).