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The intended use of the eLexus(MP3C-1) is to provide mobility to persons limited to a seated position t are capable of operating a powered wheelchair.

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This document is a 510(k) premarket notification letter from the FDA regarding the "Primechair" (later referred to as eLexus(MP3C-1)), a powered wheelchair. It is a regulatory approval document and not a scientific study report. Therefore, it does not contain information about acceptance criteria for an AI/device's performance or a study proving that the device meets such criteria in the way you've outlined.

The information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in clinical study reports or scientific publications for AI/medical device performance evaluation, not in 510(k) clearance letters for powered wheelchairs.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance characteristics evaluated in the context you're asking about for AI systems.

Therefore, I cannot extract the requested information from the provided text.

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The intended use of the eLexus is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

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I am sorry, but the provided text does not contain the information requested to answer the prompt. The document is an FDA 510(k) clearance letter for a powered wheelchair called "Primechair" (later corrected to "eLexus"). It discusses the regulatory approval process but does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or multi-reader multi-case studies.

Ask a specific question about this device