Search Results

The Invacare® Perfector™V Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare® Perfecto2™V Oxygen Concentrator. The subject device is used by patients who require supplemental oxygen concentration level of the output gas ranges from 87% to 95.6% at an output flow rate range of 1/2 to 5 liters per minute. The oxygen is delivered to the user through the use of a nasal cannula.

This document is a 510(k) Premarket Notification for the Invacare Perfecto2V Oxygen Concentrator. It asserts substantial equivalence to a predicate device, the Invacare Platinum 5 Oxygen Concentrator (K020386), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new functional claim (e.g., related to AI performance).

Therefore, I cannot extract the information required for the requested table and study details (acceptance criteria, performance, sample sizes, expert involvement, adjudication, MRMC, standalone, ground truth, training set specifics) because the provided text describes a submission for a medical device (oxygen concentrator), not a software/AI device that would involve the assessment of algorithmic performance against a ground truth.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a previously cleared predicate device.
• Bench Testing: Performance testing (e.g., oxygen concentration levels, flow rates, electrical safety, biocompatibility) to show the device meets its defined specifications and is equivalent to the predicate.
• Risk Management and Software Verification: Ensuring the device's design and software meet relevant standards.

There is no mention of an AI component, image analysis, human reader studies, or any of the elements typically associated with the kind of "acceptance criteria" and "study" described in your prompt, which are relevant to diagnostic or AI-driven medical devices.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of AI or sophisticated diagnostic performance.

Ask a specific question about this device