(480 days)
The Portable Oxygen Concentrator, model: P2-E6 is intended to provide supplemental oxygen in a home, institutional, or travel environment.
Portable Oxygen Concentrator, model: P2-E6 is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The P2-E6 is small, portable and may be used in home, institutional, or travel environment.
The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.
This document is a 510(k) Summary for a Portable Oxygen Concentrator, model: P2-E6. It seeks to demonstrate substantial equivalence to a predicate device (GCE Zen-O™ Portable Oxygen Concentrator, Model: RS-00500, K162433).
The information provided does not describe an AI medical device or a study involving human readers and AI assistance. Instead, it focuses on the engineering and performance characteristics of a physical medical device (an oxygen concentrator) and its compliance with various medical device standards. There is no mention of an algorithm or AI in the context of diagnostic or interpretive tasks for which acceptance criteria typically involve clinical performance metrics like sensitivity, specificity, or AUC based on expert reads.
Therefore, I cannot fulfill the request to discuss the acceptance criteria and study proving a device meets acceptance criteria in the context of AI assistance or diagnostic performance, as the provided text pertains to a different type of medical device clearance.
The 510(k) summary focuses on demonstrating that the new oxygen concentrator is substantially equivalent to a previously cleared predicate device by comparing:
- Intended Use and Indications for Use: Stating they are the same (supplemental oxygen in home, institutional, or travel environment).
- Technological Characteristics: Comparing design, principle of operation, oxygen concentration, settings, alerts, etc.
- Performance Testing: Referring to compliance with established consensus standards (e.g., ISO, IEC) for electrical safety, electromagnetic compatibility, biocompatibility, and specific oxygen concentrator performance (e.g., oxygen concentration, discharge pressure, breath rate, bolus size).
- Software Verification and Validation: Describing the software's level of concern, programming language, hardware platform, and testing to ensure it performs as intended.
Key takeaway from the document: The manufacturer is demonstrating the safety and effectiveness of their new oxygen concentrator by showing it meets recognized engineering and performance standards, and that any differences from the predicate device do not raise new questions of safety or effectiveness. There is no AI component or clinical reader study described.
§ 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).