Search Results

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.

Manual Wheelchair W54 is a mechanical wheelchair including four wheels, a steel frame and a textilene upholstery that is flame resistant. W54 has a physical dimension of 1160mm × 890mm (depth × width × height) with the seat itself has a dimension of 470mm × 488mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 19.7 kilograms. The color is dark black.

The components include back upholstery, handgrip, back cane, arm pad, armrest, seat upholstery, seat extension, rear wheel, handrim, anti-tipper, wheel lock, crossbrace, frame, footplate, caster, caster housing, front fork.

Main materials: Steel (Frame, crossbrace, back cane, armrest, wheel lock, footrest, front fork), hard plastics (handgrip, rear wheel, handrim, castor, footplate, castor housing), flame resistant fabrics (seat and back upholstery) and flame retardant sponge (seat stuffing), armrest pad, tire of caster and rear wheel (PU), all kinds of pipe plugs and pipe shroud for the frame and steel parts (PP)

The provided text describes the 510(k) premarket notification for a Manual Wheelchair W54. This device is a mechanical wheelchair and, as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to performance standards and non-clinical testing rather than clinical efficacy studies often associated with AI/software medical devices.

The document does not contain details about an AI/ML-based device. It is a submission for a mechanical wheelchair, therefore, many of the requested bullet points pertinent to AI/ML (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this specific device submission.

However, I can extract the information relevant to the performance of this mechanical device and its acceptance criteria as described in the document.

Acceptance Criteria and Device Performance for Manual Wheelchair W54

The acceptance criteria for the Manual Wheelchair W54 are based on compliance with various ISO standards for wheelchairs. The study proving the device meets these criteria involved non-clinical performance testing.

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

2. Sample size used for the test set and the data provenance:

• Quantitative Performance Tests: The document refers to compliance with ISO standards (e.g., ISO 7176 series for mechanical performance). These standards define specific test methods and often involve testing a single or small number of devices to demonstrate conformance. The exact "sample size" of wheelchairs tested for each specific ISO standard is not explicitly stated as a number of units, but rather the statement "Tests were conducted following the recommended procedures outlined in the respective consensus standards" and "results for 'Mechanical Wheelchair W54' met all relevant requirements."
• Usability Study: 15 participants were used for the usability study.
• Data Provenance: Not explicitly stated beyond the manufacturer being Jiangsu Jumao Medical Equipment Co., Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing lab for compliance with international standards. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable to this type of mechanical device testing. "Ground truth" in this context refers to established engineering and performance standards (ISO standards) rather than expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

This concept is not applicable. Mechanical tests according to ISO standards have objective pass/fail criteria or measurements, not subjective evaluations requiring 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:

This is not applicable as the device is a manual wheelchair, not an AI/ML-based diagnostic or assistive technology for human readers.

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

This is not applicable for a mechanical wheelchair.

7. The type of ground truth used:

• For mechanical performance: The "ground truth" is defined by the internationally recognized ISO standards (e.g., ISO 7176 series) for wheelchair design, performance, and testing. Compliance with these standards is the "ground truth" for demonstrating safety and effectiveness.
• For biocompatibility: The "ground truth" is defined by ISO 10993 series standards for biological evaluation of medical devices, involving specific lab tests (cytotoxicity, irritation, sensitization).
• For usability: The "ground truth" was established by verification & validation testing records and reported user understanding and operation ability assessed on 15 participants.

8. The sample size for the training set:

This is not applicable as the device is a mechanical wheelchair and does not utilize a "training set" in the context of AI/ML.

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

This is not applicable as the device is a mechanical wheelchair and does not utilize a "training set" in the context of AI/ML.

Ask a specific question about this device