Search Results

The Tuffcare Cruiser PP5500 Challenger powered wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

The Tuffcare Cruiser P5500 Challenger powered wheelchair is an indoor / outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels and front anti tipping devices, adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for thansport and is provided with a battery charger.

This 510(k) notification describes a powered wheelchair, not an AI/ML powered device. As such, most of the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, and training set information is not applicable.

However, I can extract information related to the physical device's testing and regulatory approval process.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria or quantitative performance metrics for the Cruiser PP5500 Challenger Powered Wheelchair. Instead, it states that:

• "Test listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission."

This indicates that the device was tested against (and presumably met) the standards set forth in a specific FDA guidance document for wheelchairs. The exact pass/fail criteria or performance results are not detailed in this summary.

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

• Sample Size: Not specified in the provided text. The testing likely involved physical prototypes of the wheelchair.
• Data Provenance: Not specified, but implied to be from the tests conducted on the physical device. The country of origin of the data is not mentioned, but the submitter is E1 Enterprises Inc / Tuffcare, based in Pompano Beach, FL, USA.
• Retrospective or Prospective: Not applicable to this type of device testing. This would be a prospective test of a physical product.

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)

• This is not applicable as this is a physical medical device (powered wheelchair), not an AI/ML algorithm requiring expert opinion for ground truth. Testing would involve engineering and safety standards, not expert clinical interpretation.

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

• This is not applicable to a physical device. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI/ML models.

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. This is a physical powered wheelchair, not an AI-assisted diagnostic or therapeutic device. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

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

• This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

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

• For a physical device like a powered wheelchair, "ground truth" would be established by objective engineering standards and safety tests outlined in the relevant FDA guidance document. Examples would include successful completion of tests for stability, braking, durability, battery life, maximum speed, and weight capacity according to pre-defined specifications. The document states that tests were conducted according to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."

8. The sample size for the training set

• This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

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

• This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

Ask a specific question about this device