(158 days)
The Precision Medical, Inc. Liquid Oxygen System is intended to provide supplemental oxygen to oxygen patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 4 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
The Precision Medical, Inc. Liquid Oxygen system consists of a vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid oxygen reservoir,where it is filled by a connection that allows the portable device to be filled by the larger reservoir. The Precision Medical Inc System is a mechanical device containing no electrical components.
The provided document is a 510(k) summary for a medical device (Precision Liquid Oxygen System) and does not contain information about a study with acceptance criteria and reported device performance metrics in the format requested.
It's a regulatory submission demonstrating substantial equivalence to a predicate device, not a performance study report with detailed statistical analysis as might be found for AI/ML devices.
Here's why the requested information cannot be fully provided based on the input:
- Type of Device: The Precision Medical, Inc. Liquid Oxygen System is a mechanical device with no electrical components. The questions in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) are highly relevant to AI/ML device evaluations, not mechanical medical devices like this one.
- Nature of "Performance Testing" described: The document states, "The Precision Medical, Inc. Liquid Oxygen System successfully passed tests in the following areas: Mechanical / Climatic Device Performance." This indicates physical and environmental testing typical for mechanical devices, not diagnostic or clinical performance metrics measured against ground truth with statistical analysis.
- Absence of Specific Data: There is no table of acceptance criteria with corresponding reported device performance values, no sample sizes for test sets, no details on ground truth establishment, no mention of experts, or any of the other AI-related study parameters.
Therefore, I cannot directly populate the requested table and detailed study information based on this document. The document confirms that performance testing was done but only provides a very high-level summary that it "successfully passed" mechanical and climatic performance tests, without specifying the criteria or the quantitative results.
If this were an AI/ML device, the detailed study information would typically be present in a much more extensive clinical or performance study report.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).