Search Results

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.

Ask a specific question about this device

The Inogen Satellite Conserver is intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas and an oxygen concentrator.

The Inogen Satellite Conserver intended to be used as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses the Inogen One Oxygen Concentrator as its oxygen supply and is connected by an oxygen supply tube. The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. Upon detecting the beginning of inhalation, the device delivers a bolus of oxygen that is equivalent in most users to 1 to 5 liters per minute constant flow, depending on the flow setting.

This 510(k) premarket notification for the Inogen Satellite Conserver does not contain the results of a study with acceptance criteria and device performance.

The document is a submission to the FDA claiming substantial equivalence to predicate devices (Medical Electronic Devices Corporation unmodified POCD and the Airsep Lifestyle Oxygen Concentrator). The content focuses on:

• Device Description: The Inogen Satellite Conserver is an accessory to an oxygen concentrator, designed to conserve oxygen by delivering a bolus during inhalation. It's microprocessor-controlled with a breath sensor and valve.
• Technological Characteristics: Claims identical electronic circuitry to a predicate, with software modifications to control the valve for oxygen bolus delivery. The dosing algorithm is stated to be identical to another predicate device.
• Summary of Testing: A statement is made that "Appropriate performance, mechanical, and electrical testing was performed to demonstrate that the Inogen Satellite Conserver would perform as intended." However, no specific acceptance criteria or detailed results of these tests are provided in this document.
• Conclusion: Based on the above, the manufacturer concludes the device is substantially equivalent to marketed devices and is safe and effective.
• FDA Response: The FDA's letter acknowledges receipt and review, confirming substantial equivalence based on the provided information, but does not detail the specific testing or acceptance criteria.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details. This document is a regulatory submission, not a study report.

Ask a specific question about this device