Search Results

The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.

The Wardray Premise MR 4500 is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to person limited to a sitting position. It may be used as an attendant propelled transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 12inch rear wheels and 5-inch front casters and handles for the wheelchair to be pushed. It is folding or non-rigid type of wheelchair that is designed for use by a patient weighing up to 280 lbs. The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.

The provided text describes the MR4500 Wheelchair and its substantial equivalence to a predicate device, focusing on its physical characteristics and MRI compatibility. It does not contain information typically found in a study proving the device meets acceptance criteria related to software performance, AI algorithms, or clinical effectiveness as one might find in a submission for a diagnostic AI device.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's what can be extracted:

Acceptance Criteria and Reported Device Performance (as far as applicable):

Information Not Available in the Provided Text:

2. Sample size used for the test set and the data provenance: Not applicable to a mechanical device's performance tests described. The "test set" here refers to the physical wheelchair being tested. The text does not provide details on the number of individual wheelchairs tested for the overload or MRI compatibility, nor the provenance of data from such tests beyond stating they were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wheelchair's mechanical and MRI safety is established through engineering standards, physical testing, and measurements, not by expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for subjective interpretations/diagnoses, not for physical test results.
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 device is a mechanical wheelchair, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical strength and MRI compatibility, the "ground truth" would be the direct measurements and observations during testing against established engineering standards (ISO 7176, ASTM F2503-8).
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described for this device):

The MR4500 Wheelchair underwent specific physical performance tests to ensure safety and functionality, particularly for its intended use in an MRI environment.

• Mechanical Strength Test: The device was subjected to a 24-hour sustained 100% overload test, which it successfully passed. This test demonstrates its structural integrity under stress.
• MRI Compatibility Test: The MR4500 was tested in 1.5T, 3.0T, and 7.0T MRI systems. The magnetic field strength and spatial gradient data indicated that no magnetically induced displacement force was produced, thus meeting the ASTM F2503-8 requirements to be labeled "MR Conditional" up to and including 7.0T.

These tests were designed to demonstrate compliance with relevant performance standards and safety requirements for a mechanical wheelchair, particularly its unique feature of MRI compatibility. The study essentially involved physical engineering tests rather than clinical or AI performance studies.

Ask a specific question about this device