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The BRAVOracer is a lightweight, rigid, high strength aluminum wheelchair for everyday use. This wheelchair provides mobility to physically challenged children. This wheelchair can be moved by the user propelling the hand rims, which are attached to the rear (drive) wheels. This wheelchair can also be pushed by an assistant grasping the pushbar attached to the back rest.
Children who are unable to walk or who have a walking impediment.

The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair. It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person. The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.

The BRAVOracer is a manual wheelchair that was determined to be substantially equivalent to the predicate device, Start Junior (K073512), based on performance testing to recognized international standards.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the number of BRAVOracer units tested. However, compliance with a suite of international standards (EN, ISO, ANSI/RESNA series) generally implies testing on a representative sample of devices to ensure robustness and consistency.
• Data Provenance: The standards testing was conducted by Berlin Cert. While the country isn't explicitly stated for "Berlin Cert", it generally refers to a certification body based in Berlin, Germany. The testing conducted to these standards is typically prospective, meaning the tests are designed and performed specifically to assess the device's adherence to the standard criteria.

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

This type of information (expert consensus, qualifications) is not applicable to the testing performed for the BRAVOracer. The "ground truth" in this context is defined by objective engineering and safety standards (e.g., strength, stability, durability, biocompatibility), not by expert interpretation of images or clinical outcomes. The testing involves standardized procedures and measurements as defined by the listed EN, ISO, and ANSI/RESNA standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements and adherence to specified performance limits within the engineering standards, rather than subjective expert review needing 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation plays a role. The BRAVOracer is a mechanical wheelchair and its evaluation focuses on engineering performance and safety.

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

Not Applicable. The BRAVOracer is a mechanical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used was objective engineering and safety standards. These standards define the acceptable performance parameters and test methods for manual wheelchairs. Compliance with these established standards serves as the "ground truth" for ensuring the device's safety and effectiveness.

8. The Sample Size for the Training Set

Not Applicable. The BRAVOracer is a mechanical device, not a machine learning model, so there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

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