Search Results

The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds.

The Wheelchair Mover is a motorized device that attaches to, and then pushes, various types of manual wheelchairs. The Wheelchair Mover is intended to push various types of manual wheelchairs up to 24 inches wide on dry, surfaced walkways indoors. Maximum patient plus wheelchair load capacity is 550 pounds. The Wheelchair Mover helps caregivers move people seated in manual wheelchairs. It is particularly useful to help move heavy manual wheelchairs up ramps, but can be used in many circumstances to make it easier to move an occupied manual wheelchair. A self-contained battery powers the Wheelchair Mover. It rolls on three wheels. The front, central one is the drive wheel that provides motive force. The Wheelchair Mover has attachment jaws that connect to the rear of the lower frame of manual wheelchairs. The person operating the Wheelchair Mover stands behind the Wheelchair Mover. The operator uses a steering handlebar and various hand-operated controls to direct the movement of the Wheelchair Mover and attached manual wheelchair with its occupant.

The provided text describes the "Dane Technologies Wheelchair Mover" and references "Functional and Safety Testing" to relevant consensus standards. However, it does not provide specific acceptance criteria or detailed study results in the format requested.

The document states: "The Dane Technologies WheelChair Mover has been tested to the relevant consensus standards for powered wheelchairs (21 CFR 890.3860, ProCode ITI) and has met the required performance criteria and functioned as intended." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred or stated based on the given text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The text only mentions "Functional and Safety Testing" without details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This type of information is usually relevant for studies involving diagnostic image analysis or expert review, which is not the nature of the device described (a motorized wheelchair mover). Ground truth for functional and safety testing would typically involve engineering specifications and objective measurements, not expert consensus in the diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in expert-reviewed data, neither of which is described for this device's testing.

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/Not provided. This device is a physical product (a wheelchair mover), not an AI diagnostic tool that human readers would use. Therefore, an MRMC study is irrelevant to its purpose and testing.

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

• Not applicable/Not provided. This device is a mechanical system with an operator, not an algorithm. Standalone performance tests would apply to its mechanical and electrical functions, which are generically stated as being compliant with standards but not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Inferred: For "Functional and Safety Testing," the ground truth would likely be based on engineering specifications, objective measurements, and compliance with the specified consensus standards (21 CFR 890.3860, ProCode ITI). The text does not elaborate further.

8. The sample size for the training set

• Not applicable/Not provided. This is a physical device, and the concept of a "training set" is generally used for machine learning models, not for traditional engineering product testing.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As above, the concept of a "training set" and its ground truth is not relevant in the context described for this device's testing.

Ask a specific question about this device