(782 days)
Refurbished Replacement Column (Sieve Bed) are regular replacement parts for Inogen One G3 Oxygen Concentrator.
The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.
The subject device is a compatible replacement part of the Inogen One G3 portable oxygen concentrator. ("POC"). Standard portable oxygen concentrators generate oxygen from room air by use of a sieve bed that removes nitrogen, other gases and impurities from the room air and generates oxygen for patients requiring supplement oxygen.
These sieve beds must be replaced on a schedule in order to maintain the POC's ability to deliver the require % oxygen. The subject device is refurbished with existing Inogen One G3 components with a new sieve bed. The final product is equivalent to the Inogen one G3 replacement sieve bed cartridge.
The provided text describes a 510(k) premarket notification for a medical device: a Refurbished Replacement Column (Sieve Bed) for the Inogen One G3 Oxygen Concentrator. However, the document does not contain information related to an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth establishment for such an AI/ML device.
The document outlines acceptance criteria and performance testing for a refurbished physical component (sieve bed), not an AI model. Therefore, I cannot extract the information required for the questions regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies.
Here's an attempt to answer the questions based only on the information present in the provided document, highlighting where the information is not applicable (N/A) because it pertains to an AI/ML study, not a physical device performance study.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests and acceptance criteria in a descriptive manner, not in a formal table with reported numeric results for each criterion. It generally states that the device "met its acceptance criteria" and provides some of the criteria.
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Summary) |
|---|---|
| Fill Volume | Met acceptance criteria |
| Oxygen Purity over time per applicable parts of ISO 80601-2-69:2020 clause 201.12.1.103 at intervals up to 8 hours (compared to predicate) | Oxygen Purity >= 90% Purity at Setting 5 at various temperature, humidity, and altitude conditions. Performance compared to predicate. Met acceptance criteria. |
| Leakage | Bed Leak Rate |
§ 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).