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The Convaid Trekker models are manual wheelchairs; Their intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.

In addition the Trekker models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.

The Trekker TR12, TR12T and TR14, TR14T are attendant propelled manual wheelchairs. They are lightweight compact folding wheelchairs with tubular 6061 aluminum frames with removable seating modules for easy transport and stowage. The seating module is also reversible to allow the caregiver the option to observe the user during use.

Front small casters for steering and maneuverability and larger wheels in the rear. A tilt function for pressure relief and the recline function provide adjustability for the lower extremities.

Foot operated wheel locks provide easy operation.

Positioning options include H-harness, two point seat belt, three point seat belt with crotch pad additional non-positioning accessories include under seat storage basket, adjustable I.V. Pole.

Trekker transit option TR12T and TR14T transit models are identical to the TR12 and TR14 except for the factory installation of four (4) tie-down anchors and required labeling. They meet the requirements for use as seating in motor vehicles when used in conjunction with the vehicle supplied four (4) wheelchair tie-down system that attaches to the four (4) transport anchors on the wheelchair and a three (3) point occupant restraint system in accordance with SAE J2249 or WC4:2012 section 18 that creates the shoulder and lap belt combination that attaches to the wheelchair or to the floor of the vehicle.

This document describes the Convaid Trekker manual wheelchairs (TR12, TR14, TR12T, TR14T) and their substantial equivalence to the predicate device, the Convaid Champ (CH10, CH10T). Since this is a 510(k) premarket notification for a Class I device, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy through clinical studies for a novel device. Therefore, the information provided below will reflect this specific regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Convaid Trekker wheelchairs are defined by their compliance with various industry standards, primarily from ANSI-RESNA and ISO. The "reported device performance" is essentially the statement of compliance to these standards and the determination of substantial equivalence.

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

• Sample Size: The document does not specify a "sample size" in terms of number of manufactured units tested. Instead, it states that Convaid's Trekker manual wheelchairs "meet the applicable performance requirements as specified below," referring to the list of ANSI-RESNA and ISO standards. This implies that testing was conducted on representative units of the Trekker models to demonstrate compliance with these engineering and safety standards. The specific number of units tested per standard is not detailed in this summary.
• Data Provenance: The data provenance is from non-clinical testing conducted by the manufacturer, Convaid Products Inc., to demonstrate compliance with recognized industry standards. The country of origin of the data is implicitly the United States (where Convaid is based and where the FDA evaluates the submission). The testing is prospective in the sense that it was performed specifically for this 510(k) submission to demonstrate compliance.

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

This type of information is generally not applicable to a 510(k) submission for a Class I mechanical device like a wheelchair. "Ground truth" in this context refers to compliance with established engineering and safety standards, which is typically validated through objective laboratory testing and measurements. Expert consensus or clinical adjudication is not typically used to establish ground truth for adherence to these types of performance standards. The "experts" involved would be qualified test engineers and technicians performing the standard-defined tests.

4. Adjudication Method for the Test Set

Not applicable in the context of demonstrating compliance with engineering and safety standards. The "adjudication" is essentially the testing laboratory reporting whether the device passed or failed each specific requirement of the cited standards.

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

Not applicable. This is not an AI-powered diagnostic or assistive device. It is a mechanical wheelchair.

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

Not applicable. This is a mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is adherence to the technical, safety, and performance requirements specified in the following industry standards:

• ANSI-RESNA WC 1:2009 series (Sections 1, 5, 7, 8, 11, 13, 15, 16, 22, 26) - These are likely standards related to general wheelchair performance, stability, durability, strength, and other mechanical aspects.
• ANSI-RESNA WC 2:2009-3 (likely for pediatric or specific user group wheelchairs)
• RESNA WC4:2012 section 19 - Specifically for wheelchairs used as seats in motor vehicles (for the Trekker Transit models).
• WCVol.1 section 19:2000 - The equivalent standard for the predicate Champ Transit models.
• ISO 10993-5 (Biocompatibility) - Specifically for in vitro cytotoxicity testing of patient-contacting materials.

The "ground truth" is verified by objective measurements and tests according to the methodology outlined in these standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the machine learning sense. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.

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

Not applicable, as there is no "training set." The design and validation of the device are based on engineering principles and compliance with established standards, which serve as the "ground truth" for its safety and performance.

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