Search Results

The Power Wheelchair (N5909) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

This Power wheelchair, N5909, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

The provided text describes the regulatory clearance of a Power Wheelchair (N5909) and establishes its substantial equivalence to a predicate device (K220747). The acceptance criteria are based on various performance standards and safety evaluations, with the study demonstrating compliance through non-clinical testing.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of ISO and IEC standards for wheelchairs. The reported device performance is demonstrated by the successful completion of tests adhering to these standards, ensuring the subject device meets or exceeds the specifications of the predicate device for relevant attributes.

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

The document does not explicitly state the sample size for the test set used for the performance testing. The provenance of the data is non-clinical bench testing, conducted according to various international standards (ISO, IEC). The location of the testing is not specified, but the manufacturer is based in China. The testing is implicitly prospective in the sense that the new device was subjected to these tests to demonstrate compliance.

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

This information is not applicable. The "ground truth" for a power wheelchair's performance is established by objective engineering measurements against defined international standards (ISO, IEC). It does not involve expert interpretation or clinical judgment in the same way an AI diagnostic device would require.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for medical images or diagnoses. For a physical device like a power wheelchair, adherence to predefined measurement procedures and standards is the primary method of evaluation.

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 MRMC comparative effectiveness study was done. This type of study is relevant for AI image analysis or diagnostic tools, not for the regulatory clearance of a physical medical device like a powered wheelchair.

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

This information is not applicable. "Standalone" performance refers to AI algorithms operating without human intervention for diagnostic or analytical tasks. The device in question is a physical power wheelchair; its "performance" is its mechanical and electrical function, not an algorithm's output. Software validation was performed, but it's not "algorithm only" performance in the context of an AI diagnostic.

7. The type of ground truth used

The ground truth used is primarily objective engineering measurements and adherence to international performance standards (ISO, IEC). For example, braking distance is measured directly, not subject to expert consensus. Biocompatibility is determined by standardized laboratory tests.

8. The sample size for the training set

The concept of a "training set" is not applicable here because this is not an AI/machine learning device that requires a training phase.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device