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The RoughRider America™ RoughRider Aurora™ Manual Wheelchair is indicated to provide mobility to persons restricted to a seated position up to a weight capacity of up to 250 lb / 114 kg.

The RoughRider America™ RoughRider Aurora™ Manual Wheelchair (Aurora) is a user propelled, manually operated folding wheelchair. The Aurora is designed for everyday use and to help its rider move around easily, safely, and without the restrictions imposed by much of the terrain encounter in daily life. The Aurora is expected to perform well:

• Indoors and outdoors; ●
• Over smooth, rough, and uneven ground; ●
• Over soft and hard surfaces; ●
• Over small obstacles, like door jams; and ●
• Up, down and across slopes. ●
  The Aurora utilizes primarily aluminum tubing that is bent, fastened, and/or welded to create a frame. The frame is comprised primarily of side frame, X-brace, foot rest, and caster fork subassemblies. Upholstery is made from fire-resistance fabric. The rear wheels of the Aurora can be removed making the wheelchair lighter for lifting or carrying.
  The side frames have three axle holes that allow the rear wheel position to be adjusted forward and backward. Wheel position affects the rider's forward and backward stability by changing wheel axle position relative to the person's center of gravity. The position of the rear wheel relative to the rider's center of gravity also affects the amount of the rider's weight that is distributed onto the front casters, and allows the rider to maximize maneuverability and control.
  The Aurora side frame fenders act as fixed arm rests and enable transferring in and out of the wheelchair. The side frame also includes the backrest tubes and push handles. The backrest tubes can be adjusted up and down to meet basic support requirements of the rider and/or their companion. Wheel locks attach to the side frame and prevent the rear wheels from turning. The locks keep the wheels from moving during transfers or when a stationary position is necessary.
  An X-Brace connects the side frames of the wheelchair together, determines the chair width, and allows the frame to fold. With the X-Brace in the unfolded position, the chair performs much like a typical X-Brace folding wheelchair. The Aurora can be easily folded for stowage or storage and fits easily into the cargo carrying areas of most vehicles.
  The seat upholstery fastens to the top surface of each X-brace seat tube and provides support for the rider to sit. The angled, sling-style seat and tension-adjustable back fabric offers seating suitable for many different riders. The tilted seat helps keep the rider slightly reclined to reduce the chances of tipping forward and out of the chair. The back fabric can be adjusted to increase or reduce back fabric tension. The seat width of the Aurora is determined by the size of the x
  brace and the seat fabric and fixed at the point of fabrication, based on the customer order. The seat can be used with a range of wheelchair and flotation (pressure relief) cushions.
  The footrests are not easily removable and support the rider's lower legs or feet. The footrests are independently adjustable up and down to position the rider's legs appropriately. The footrests are hinged and can be folded up to enable easier transfers into and out of the Aurora. When the Aurora is unfolded, and the rider is sitting in the chair, the footrest design can give the rider added protection for their toes from doors or other obstacles.
  The casters include the caster wheels (hubs and tires) and a caster fork. The caster is mounted to the front of the side frame using the caster barrel. The casters can turn freely 360°. The casters of the Aurora are positioned approximately five inches further forward than most hospital- or boxstyle wheelchair designs. This additional distance gives the rider of the Aurora a stable ride, in terms of forward stability.
  To prevent unintended changes to the chair configuration and reduce risk to the rider, most adjustment (footrest and backrest height) require access to basic tools.
  The maximum weight capacity of the chair is 250 lb (114kg).
  The Aurora is based on and substantially equivalent to the established and tested design, of the Whirlwind RoughRider. This design has been refined with input from thousands of wheelchair riders around the world after over 15 years of use. The Aurora is easy to clean and uses a range of standardized components that are easy to maintain and replace.

The provided text is a 510(k) Summary for a manual wheelchair, the "RoughRider America™ RoughRider Aurora™ Manual Wheelchair." It primarily focuses on demonstrating substantial equivalence to a predicate device, the "Whirlwind RoughRider Wheelchair," by comparing technological characteristics and presenting performance data based on recognized consensus standards.

This document does not describe a study involving an AI/algorithmic device or its acceptance criteria based on human-in-the-loop performance, expert ground truth establishment, training sets, or adjudication methods. The "device" in question is a physical manual wheelchair.

Therefore, for the specific questions related to AI/algorithmic device validation (acceptance criteria, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.), the provided text does not contain the information needed to answer them.

The document does discuss performance data for the wheelchair in terms of meeting specific ISO standards. If the intent was to understand the "acceptance criteria" and "study" for a physical device based on this document, here's an interpretation:

Acceptance Criteria and Supporting Study for a Manual Wheelchair (Physical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RoughRider America™ RoughRider Aurora™ Manual Wheelchair are primarily framed in terms of meeting the requirements and passing the tests outlined in a set of FDA-Recognized Consensus Standards (ISO standards). While specific numerical acceptance thresholds within each ISO standard are not detailed in this summary, the general criterion is "The applicable tests described in these standards were passed."

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

For a physical device like a wheelchair, "test set" typically refers to the number of physical units subjected to testing, rather than a dataset of clinical images. The document does not specify the number of wheelchair units tested. The data provenance is implied to be from laboratory testing conducted by the manufacturer or a contracted testing facility, as per the mentioned ISO standards. It is not clinical data (retrospective or prospective).

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

This question is not applicable to the validation of a physical manual wheelchair. "Ground truth" in this context would be derived from physical measurements and mechanical stress tests according to standardized protocols, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. The "tests" here are standardized engineering and mechanical performance tests, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a manual wheelchair, not an AI or imaging diagnostic tool.

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

This question is not applicable as the device is not an algorithm. The "standalone performance" of the wheelchair refers to its ability to meet the stated ISO standards and functional specifications independently.

7. The Type of Ground Truth Used

For this medical device, the "ground truth" is established by:

• Standardized Test Protocols: The specific methodologies and measurements defined within the cited ISO 7176 series standards.
• Physical Measurements and Mechanical Performance: Quantitative outcomes from these standardized tests, such as stability angles, dimensions, mass, and resistance to force (fatigue, impact).
• Material Properties: Verification that the aluminum frame meets material strength and durability specifications to support increased weight capacity.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of validating a physical manual wheelchair. The design refinements over 15 years, informed by "thousands of wheelchair riders around the world," represent an iterative design and improvement process, but not an algorithmic training set.

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

Not applicable, as there is no training set as defined for an AI device. The design evolution was based on real-world use and feedback, leading to refinements in features like the adjustable backrest and material choice (aluminum for lighter weight and higher capacity).

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