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The intended use of the Pride Mobility Products Corporation Z-Chair Powered Wheelchair, is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

The Z-Chair is a compact battery-operated power wheelchair featuring rear-wheel drive technology, front casters, rear anti-tip wheels and is designed for, but not limited to Pride providers / retailers and their consumers. As a motorized wheelchair, the Z-Chair offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, off-board battery charger, a fully programmable 50-amp controller, and a 12-volt, 30-amp hour battery pack. Accessories include a lap belt, cup holder, and zippered accessory pouch. The Z-Chair is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Z-Chair is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of transport. The Z-Chair has a lightweight foldable seat, and a single-post, quick-release seat mount.

The provided document is a 510(k) summary for the Pride Mobility Products Corporation Z-Chair Power Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. This document does NOT describe a study involving acceptance criteria and device performance in the context of a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a medical device algorithm.

The document explicitly states:

• Discussion of Clinical Testing Performed: N/A

This indicates that no clinical studies were performed to assess the performance of the device in a human-in-the-loop setting or as a standalone algorithm. The device described is a physical power wheelchair, not an AI/software device.

However, I can provide information based on the non-clinical testing discussed in the document, framed as demonstrating compliance with applicable testing standards, which serve as a form of "acceptance criteria" for this type of physical device.

Summary of Non-Clinical Testing and Compliance (Interpreted as "Acceptance Criteria" for a Physical Device)

The Z-Chair Power Wheelchair underwent non-clinical testing to demonstrate compliance with various ANSI/RESNA and other standards. These standards implicitly define the "acceptance criteria" for the safety, performance, and functionality of the wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of an algorithm's test set. For a physical product, testing is typically performed on one or more representative units (prototypes or production models). The document does not specify the number of units tested.
• Data Provenance: Not applicable in the traditional sense of retrospective/prospective clinical data or country of origin. The data provenance is from laboratory/engineering testing against specified performance standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not applicable. This document pertains to the physical performance testing of a wheelchair, not the assessment of diagnostic accuracy by medical experts. "Ground truth" here is defined by objective engineering measurements and the pass/fail criteria of the specified standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies. For physical product testing, results are typically determined by adherence to established test protocols and instrument readings or visual inspections, with criteria defined by the testing standards themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

• No, an MRMC comparative effectiveness study was not done. The device is a physical power wheelchair, not an AI diagnostic/analytic tool.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. The device is a physical power wheelchair, not an AI algorithm.

7. Type of Ground Truth Used

• For this physical device, the "ground truth" for the non-clinical testing is implicitly defined by the objective pass/fail criteria and measurement tolerances set forth in each of the referenced ANSI/RESNA and CAL 117 standards. For example, for static stability, the ground truth would be whether the wheelchair remains stable under specified conditions as defined by ANSI/RESNA WC/01.

8. Sample Size for Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The design and engineering of the Z-Chair would be based on general engineering principles and design specifications, not a "training set" of data.

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

• Not applicable. There is no training set for this physical device.

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