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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armirests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembly d for transport and is provided with an onboard battery charger.

This document describes a 510(k) premarket notification for a powered wheelchair, the WU'S POWERED WHEELCHAIR, MAMBO 36X (later changed to FORYOU POWER WHEELCHAIR, FC-100). The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, many of the requested categories related to acceptance criteria, ground truth, expert review, and sample sizes for a performance study are not directly applicable or available in this type of submission. The "study" mentioned is a comparison to a legally marketed device to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not typically presented for a 510(k) submission showing substantial equivalence for a powered wheelchair. The "acceptance criteria" here are generally compliance with relevant standards and demonstrating equivalence in key performance characteristics to a predicate device, rather than quantitative performance targets.

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

• Sample Size: Not applicable. No "test set" in the sense of patient data or clinical images was used. The substantial equivalence was based on a comparison of device specifications, materials, and compliance with performance standards.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. No ground truth based on expert review was established for this submission. The "ground truth" for substantial equivalence is the predicate device's characteristics and its prior clearance.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is a medical device clearance based on substantial equivalence, not an AI efficacy study.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This device is a physical product (powered wheelchair), not an algorithm. Performance refers to mechanical and electrical safety standards compliance.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the characteristics and performance of the legally marketed predicate device (TEH LIN JUPITER Powered Wheelchair TL-320 (K022697)) and compliance with relevant performance standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995).

8. Sample Size for the Training Set

• Sample Size: Not applicable. There is no AI model or "training set" for a powered wheelchair.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

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