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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors, and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees.

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.

"Nuocande Plastic Manual Wheelchair Model NKD L07" is user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees. Each consists of four wheels, a mechanical frame and nylon upholstery that is ignition resistant.

"Nuocande Plastic Manual Wheelchair Model NKD L07" has a physical dimension of a physical dimension of 1090 (depth) x 730 (width) x 850 (height) mm, with the seat itself has a dimension of 411 (depth) x 447 (width) x 365 (height) mm. The device has a weight capacity of 100 kilograms, and weighs about 19 kilograms. The color is dark yellow.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nuocande Plastic Manual Wheelchair Model NKD L07:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. The tests were performed on the "Nuocande Plastic Manual Wheelchair Model NKD L07" itself. The data provenance is from non-clinical testing conducted according to international standards. The country of origin for the device manufacturing is China (Ningbo, Zhejiang). The study is prospective in the sense that the device was manufactured and then tested to these standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. For a physical device like a wheelchair, "ground truth" is established by adherence to widely accepted engineering and safety standards (ISO standards in this case) through objective measurements and destructive/non-destructive testing, rather than expert consensus on a diagnostic image or clinical finding.

4. Adjudication Method for the Test Set

This information is not applicable, as it pertains to subjective assessments or diagnostic interpretations, which are not relevant for the performance testing of a mechanical wheelchair.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of data (e.g., medical imaging). The current document describes testing of a mechanical device against objective performance standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a mechanical wheelchair, not an algorithm. The performance evaluation is inherently "standalone" in the sense that it evaluates the physical product's compliance with specified standards, without human interaction influencing the measurement of that compliance (beyond operating the testing equipment).

7. The Type of Ground Truth Used

The "ground truth" used is adherence to international consensus standards for mechanical wheelchairs, specifically various parts of ISO 7176. These standards define objective performance thresholds and testing methodologies that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The current document describes the testing of a manufactured physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this type of device submission.

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