(125 days)
The Oxygen Concentrators are indicated for the delivery of supplemental oxygen in the home or medical institutions. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
The Merits Health Products 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 for life-supporting nor life-sustaining devices. The devices operate through the use 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. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into first chamber of the dual-chambers aluminum extruded molecular sieve tank. As the oxygen is forced out of the end of the first chamber and then enters the Oxygen tank for patient use. As the remaining Oxygen flush the nitrogen out of the first molecular sieve chamber into the ambient air, the air is directed into the second molecular sieve chamber and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. Optional oxygen-driven-nebulizer is provided for patients who are prscribed for oxygen aerosol therapy by physician, using higher purity oxygen to drive a nebulizer while oxygen therapy is being undertaken. Optional oxygen-driven-nebulizer allows a single wnit to meet the different needs of oxygen or oxygen-aerosol therapy patients. This submission covers a model that will have a maximum output of 10-liters per minute as compared to the currently marketed model. Options will include an Oxygen alarm, pediatric flowmeter and nebulizer.
The provided text describes a 510(k) submission for the Merits Health Products Oxygen Concentrators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive studies with acceptance criteria and statistical analysis typical of new drug or high-risk device approvals. Therefore, the information requested in the prompt, particularly regarding acceptance criteria, sample sizes, expert ground truth, adjudication, and MRMC studies, is largely not applicable or not present in this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." However, specific acceptance criteria (e.g., oxygen purity within a certain range at specific flow rates) and a detailed table of measured performance against these criteria are not provided in this summary. The assessment of equivalence is based on "design, performance specifications, testing and intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a "test set" in the context of clinical data or human subjects. The testing performed would likely have been engineering and performance testing on the device itself (e.g., oxygen purity, flow rate, pressure, noise levels, internal component specifications). Details about the sample size of devices tested or the provenance of any data beyond the general manufacturing location (Taichung, Taiwan R.O.C.) are not provided. This was likely internal validation testing.
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)
This concept is not applicable to this type of device and submission. "Ground truth" established by experts is typically for diagnostic imaging devices or other medical technologies where human interpretation or a gold standard diagnosis is involved. For an oxygen concentrator, the "ground truth" would be objective measurements of its physical performance parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a human-interpreted "test set" or diagnostic assessment requiring adjudication.
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
An MRMC study is not applicable here. This type of study is relevant for AI-powered diagnostic tools or imaging interpretation software where multiple human readers assess cases with and without AI assistance. This device is an oxygen concentrator, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (an oxygen concentrator), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an oxygen concentrator, the "ground truth" for performance would be objective engineering measurements of parameters such as:
- Oxygen purity (%)
- Flow rate (LPM)
- Output pressure
- Noise levels
- Power consumption
- Alarm functionality (e.g., low oxygen purity alarm)
These would be measured using calibrated equipment according to industry standards. The document states "The results of the testing confirm that the device meets specifications," implying these types of objective measurements were performed.
8. The sample size for the training set
This is not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model.
Summary of Device Performance (Based on Substantial Equivalence Claim):
The document does not provide specific numerical performance data against acceptance criteria. Instead, it makes a general statement of compliance and substantial equivalence:
- Claim: "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device."
- Basis for Substantial Equivalence:
- Key Performance Area (Implicit): The device is intended to provide "supplemental oxygen up to 10 LPM" with an oxygen purity of "approximately 93%." The testing would have verified these parameters against the predicate devices or established specifications.
§ 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).