(35 days)
Intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas as part of an oxygen delivery system including an oxygen concentrator, compressed oxygen cylinders, or liquid oxygen system.
The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. The device is connected to an oxygen supply source and upon detecting the beginning of an inhalation; the device delivers a bolus of oxygen that is equivalent in most users, depending on the flow setting, to 1 to 5 liters per minute constant flow. The Inogen Satellite Conserver can be used with bottled oxygen systems and as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses these systems as its oxygen supply and is connected by an oxygen supply tube.
The provided document is a 510(k) summary for a medical device (Inogen Satellite Conserver) and does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML powered device.
Specifically, the document focuses on demonstrating substantial equivalence to predicate devices for a modified oxygen conserver, which is a hardware device, not an AI/ML powered medical device. The "Summary of Testing" section (Page 2) refers to "extensive software validation testing, safety testing, mechanical testing, performance testing, and EMI/EMC testing" for the original device, and "Comprehensive performance testing with compressed oxygen cylinders and liquid oxygen systems" for the new device to ensure it "functioned within its specifications."
However, none of this testing aligns with the requirements of describing acceptance criteria and a study for an AI/ML powered device, which would involve:
- Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC, F1-score).
- A test set with ground truth established by experts.
- Details on reader studies (MRMC) or standalone algorithm performance.
- Information about training sets and their ground truth.
Therefore, I cannot provide the requested information based on the input text.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).