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510(k) Data Aggregation
(308 days)
The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
The Pioneer U121 Series CPAP operates using standard AC Power from a wall outlet. This U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motordriven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit. The pressurized air is delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. This device only requires minimal cleaning and periodic dealer service checks to ensure optimum performance.
This looks like a 510(k) premarket notification for a Continuous Positive Airway Pressure (CPAP) device, not an AI/ML medical device. Therefore, a significant portion of the requested information (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not provided in this type of submission for this kind of device.
However, I can extract the available information related to acceptance criteria and performance as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets specifications | The results of the testing confirm that the device meets specifications. |
| Substantially equivalent to predicate device (Invacare Polaris CPAP System K982242) | The Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the Invacare Polaris CPAP System (K982242). |
| Operates using standard AC Power | Operates using standard AC Power from a wall outlet. |
| Delivers continuous positive air pressure to the upper airway | Delivers continuous positive air pressure to the upper airway. |
| Intended for treating adult Obstructive Sleep Apnea (OSA) in the home | Indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home. |
| Not intended for life support | Not intended for life support. |
| Does not provide patient monitoring capabilities | Do not provide any patient monitoring capabilities. |
| Microprocessor-based control system for pressure regulation | A microprocessor based control system. Controls the pressure of air delivered by monitoring the speed of motor-driven blower. |
| Filtration of air | Air, which penetrates through the filter, is directed to the motor-driven blower. |
| Delivery via flexible tubing (22 mm internal diameter) and standard nasal mask with exhaust port | Delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. |
| Minimal cleaning and periodic dealer service checks required | Only requires minimal cleaning and periodic dealer service checks to ensure optimum performance. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. For a traditional mechanical device like a CPAP, performance testing typically involves engineering and functional validation against design specifications and established standards, rather than testing on clinical patient "test sets" in the way an AI/ML algorithm would be. The focus is on the device's physical function and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation tasks, which is not relevant for this CPAP device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are used in studies involving human interpretation or clinical endpoints, not for the functional testing of a CPAP machine.
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:
- No. This is a mechanical CPAP device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effectiveness are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical CPAP device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device would be its adherence to engineering specifications, safety standards, and functional performance metrics (e.g., pressure delivery accuracy, flow rate, noise levels, etc.) as demonstrated through laboratory and bench testing. These are compared against the predicate device's established performance and recognized standards for CPAP machines.
8. The sample size for the training set:
- Not applicable / Not provided. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no AI/ML component, there is no training set or associated ground truth establishment.
In summary, the provided document describes a traditional medical device (CPAP) and its premarket notification. The "study" referenced in the acceptance criteria is performance testing against engineering specifications and a comparison to a predicate device to establish substantial equivalence, rather than a clinical trial or algorithm validation study.
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