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The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.

The Catalyst is a traditional folding cross-brace wheelchair. It is made of lightweight aluminum tubing similar to what is used on existing products. The frame utilizes two cross tube sets and, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled 2 machined aluminum axle plates. Stainless steel receivers are mounted within the axle plates. Wheels of varying size and type are connected to the receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 backtubes are inserted to the desired height. Backrest upholstery is affixed to the backtubes. Armrests receivers bolt onto the rear of each side frame. Individual Swing Away tubular arms are then inserted into the receivers. If flipback armrests are chosen a receiver is mounted onto the from of each side frame to catch the forward most section of the arm and the rear mounting is pivoting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the outside of the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Swing Away footrests with footplates and heel loops attach at the front of the chair. There is a plug at the top of the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is turned 90 degrees away from the frame. Hold the latch, which is midway down the hanger, tightly against the front of the frame and rotate the footrest back towards center. The latch will engage once the footrest hanger is centered.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Catalyst manual wheelchair. It outlines the device description, intended use, comparison to a predicate device, and performance testing results.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It states that the "Catalyst has been tested," implying a physical testing of the device itself rather than a data-driven study on a set of cases.

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device like a wheelchair is established through adherence to engineering and safety standards, not through expert consensus on diagnostic interpretations. The device's performance is measured against these established standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which is not the case for the physical testing of a wheelchair against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable and not provided in the document. The device is a manual wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable and not provided in the document. The device is a physical mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's acceptance is based on adherence to recognized international engineering and safety standards, specifically:

• ANSI/RESNA WC Volume 1 - 1998 Standards - Sections 1, 5, 7, 8, 16 & 93.
  • Section 1: Determination of static stability
  • Section 5: Determination of Overall Dimensions, Mass and Turning Space
  • Section 7: Measurement of seating and wheel dimensions
  • Section 8: Static, impact, and fatigue strengths
  • Section 16: Determination of Flammability
  • Section 93: Maximum Overall Dimension

These standards themselves define the "ground truth" for what constitutes a safe and effective manual wheelchair.

8. The Sample Size for the Training Set:

This information is not applicable and not provided in the document. As a physical product, there is no "training set" in the context of an algorithm or AI model development. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, rather than a formal data training set.

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

This information is not applicable and not provided in the document for the reasons explained in point 8. The "ground truth" for manufacturing a wheelchair is established through engineering specifications, material properties, and quality control processes to ensure the final product meets the defined safety and performance standards.

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