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The YJ- K1,K2 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for a manual wheelchair (YJ-K1/K2 Wheelchair) and does not describe acceptance criteria or a study related to an AI/ML-driven device. The document primarily focuses on demonstrating substantial equivalence to a predicate manual wheelchair through non-clinical performance testing and biocompatibility testing.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not available within this document.

The document states:

"No clinical study is included in this submission." (Page 8)
The tests conducted are non-clinical, focusing on mechanical performance and biocompatibility to standards like ISO 7176 series and ISO 10993 series. (Page 8)
The device is a "mechanical wheelchair" (Page 5).

Since the request is specifically for a device that would require such studies (e.g., an AI/ML diagnostic device), and this document describes a manual wheelchair, it is not possible to extract the requested information.

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