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The A006 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The subject device is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing 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 maneuver 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.

This document describes the FDA's clearance of a Manual Wheelchair (Model A006) and is a 510(k) Premarket Notification. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process differs significantly from studies that prove a medical device, especially AI/ML-driven software, meets specific performance acceptance criteria through clinical or non-clinical trials.

Therefore, the provided text does not contain the information required to answer the prompt. It is a regulatory clearance document for a mechanical device, not a study evaluating the performance of an AI/ML device against acceptance criteria.

Here's why the prompt cannot be answered with this document:

• No AI/ML device: The device in question is a manual wheelchair, a physical, mechanical product. There is no software, AI, or algorithm involved.
• No "acceptance criteria" in the AI/ML performance sense: The "acceptance criteria" here refer to meeting regulatory standards for safety and effectiveness in comparison to a predicate mechanical device (another wheelchair), not to the performance metrics (like accuracy, sensitivity, specificity, AUC) typically established for AI/ML devices.
• No "study" in the AI/ML performance sense: The document describes non-clinical performance testing against established ISO standards for wheelchairs (e.g., static stability, brake effectiveness, dimensions, strength). It explicitly states, "No clinical study is included in this submission." There are no human readers, ground truth establishment, training sets, test sets, or MRMC studies as would be relevant for an AI/ML device.

To answer the prompt, a document describing the development and validation of an AI/ML-driven medical device, including performance data from a clinical or non-clinical study, would be necessary.

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The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black.

This document describes the premarket notification for the Manual Wheelchair, Model A011. The information provided is for a physical medical device (a manual wheelchair) and not a software/AI-based medical device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and details about training/test sets for an algorithm, are not applicable to this submission.

The acceptance criteria for this device are based on performance standards for manual wheelchairs and comparisons to a predicate device, focusing on physical characteristics and safety.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally "Meets [ISO Standard]" or "Comply with [ISO Standard]," implying that the device's performance reached the thresholds defined by these international standards. The reported device performance is explicitly stated as meeting these standards.

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