(101 days)
The OxLife oxygen concentrators are intended to provide supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The OxLife 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 works by filtering room air into a holding tank. The air is then flushed through two aluminum welded molecular sieve tanks in series. The molecular sieve material absorbs nitrogen which comprises approximately 78% of the makeup of the room air. The resulting gas is approximately 93% oxygen.
This modification is designed to increase the output of the device to enable an oxygen flow of uc to 6 LPM at 93% ± 3% purity. The device will be marketed with several options to provide the most marketing flexibility. One set of devices will be marketed with a single oxygen outlet through a single flow meter. The others will be marketed with two oxygen outlets, each with it's own regulator and flow meter. The single outlet devices will be sold with a 5 LPM (L-5) model or 6 LPM (L-6) model with a 5 LPM or 6 LPM flow meter respectively. The dual outlet device (DL-3) will be marketed with two 6 LPM flow meters. This device is designed to provide for the needs of two patients in any combination of flows up to 6 LPM. The major change to the device has been the replacement of the single-headed Thomas WOB-L compressor with a dual-headed Thomas WOB-L compressor. This doubled the output to 3 CFM, facilitating the increased oxygen flow.
The provided text describes a medical device modification (K955549 for OxLife Oxygen Concentrators) and its comparison to a predicate device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, expert opinions, or the methodologies typically associated with assessing AI or diagnostic device performance.
The document focuses on:
- Device Description: How the oxygen concentrator works (filtering air, using molecular sieves to absorb nitrogen) and the specific modifications made (upgraded compressor, increased circuit breaker).
- Performance Specifications: Increased oxygen flow rate (up to 6 LPM) and maintained oxygen concentration accuracy (93% +/- 3% for flows > 2 LPM).
- Comparison to Predicate: Asserting substantial equivalence to an existing device (K933081) based on design, performance specifications, and intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study or performance validation against explicit acceptance criteria in the manner you've outlined. This type of submission often relies on engineering and functional testing data to show that the modified device performs as intended and is as safe and effective as the predicate.
§ 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).