(120 days)
Invacare® Platinum® Mobile Oxygen Concentrator: The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.
Invacare Mobile Medical Application Accessory PICCOLO O2: The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.
The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level.
- . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
- . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices
- POC1 USB Bluetooth Dongle .
The provided text describes a 510(k) submission for the Invacare Platinum Mobile Oxygen Concentrator with Connectivity and its associated mobile application. However, the document does not contain the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven medical device.
This document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already legally marketed. It highlights design verification testing, risk management, software verification, electrical safety, wireless coexistence, cybersecurity, and biocompatibility testing. It explicitly states that clinical testing was not required for this submission.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set sample size, expert involvement, or AI/MRMC studies because the provided text does not contain this information. The device in question is a portable oxygen concentrator with a mobile app for displaying settings and controlling flow, not an AI/ML diagnostic or therapeutic device which would typically require the kind of performance studies you are asking about.
I can only confirm that based on the provided text:
- Clinical testing was not required for this submission. This implies there was no study proving the device meets acceptance criteria related to clinical performance on a test set of patient data, as would be expected for an AI/ML device.
- The "study" that proves the device meets acceptance criteria in this context appears to be the design verification testing, software verification testing, electrical safety/EMC testing, wireless coexistence, and cybersecurity documentation. These tests demonstrate the device functions as intended and safely, but not in the way an AI/ML algorithm's diagnostic or therapeutic performance would be evaluated.
- The ground truth for these engineering performance tests would be established by direct measurements against known standards and specifications, not by expert consensus or pathology on patient data.
If you have a document describing an AI/ML device, please provide that, and I would be able to answer your questions more comprehensively.
§ 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).