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The device is indicated to provide mobility to persons limited to a sitting position.

The Küschall K-Series Attract Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject device is a lightweight rigid "non-folding" design. Several adjustments such as: center of gravity, seat to floor height, backrest angle, and knee to heel length can be made to the subject device to meet the individual user needs. The chair can be either equipped with a 75° or 90° frame angle. Multiple wheel locks are available, as well as other safety accessories such as anti-tippers. There is no prior submission for the subject device.

The provided document is a 510(k) premarket notification for a manual wheelchair. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets them for an AI/CAD system.

Here's why and what information is missing:

• Device Type: The device is a "Küschall K-Series Attract Manual Wheelchair," which is a physical medical device, not a software or AI/CAD system.
• Study Type Implied by Questions: The questions (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are specific to the evaluation of AI, machine learning, or computer-aided detection/diagnosis systems, which involve algorithms making interpretations or classifications.
• Nature of "Performance Data" in Document: The "Performance Data" section describes non-clinical performance testing against established standards for physical wheelchairs (e.g., static stability, brake effectiveness, dimensions, strength, flammability, biocompatibility). It does not involve diagnostic accuracy metrics like sensitivity, specificity, AUC, or F1-score which would be relevant for AI systems.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating substantial equivalence based on physical characteristics and adherence to safety standards for a mechanical device.

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