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The Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. It is not intended to be used during flight.

The Walk on Wheels HD-3500 Electric Aisle Wheelchair is a power wheelchair designed to transport elderly or disabled persons on/off an airplane. It has a base with four wheels, a padded seat with adjustable armrests and seatbelt, adjustable/removable foot rests with a leg band, and hand controls located at the back of the wheelchair allowing an attendant to control the chair. It can be disassembled for transport and is provided with an off-board battery charger.

The provided FDA 510(k) summary for the Walk on Wheels HS-3500 Electric Aisle Wheelchair describes non-clinical performance testing and explicitly states that no clinical testing was included in the submission. Therefore, the device's acceptance criteria are based entirely on non-clinical performance, and a study proving the device meets acceptance criteria in a clinical setting (i.e., with human subjects) was not conducted.

Here's an breakdown of the information requested, based solely on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be compliance with the specified standards and the successful completion of the listed tests. The reported device performance is that it met these criteria.

Study Details for Acceptance Criteria

1. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified for the non-clinical tests. It would typically involve testing of device prototypes or production units, not a "test set" in the sense of patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed on the device itself.

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

• Not applicable. No "ground truth" was established by experts in the context of clinical data for this non-clinical testing. The "ground truth" was the objective measurement against established engineering and performance standards.

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

• Not applicable. This is not a human adjudication process. Test results would be objectively measured against predefined pass/fail criteria outlined in the standards.

4. 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. The document explicitly states: "Clinical testing is not included in this submission." An MRMC study involves human readers, which falls under clinical testing. Furthermore, this device is a mechanical wheelchair and does not contain AI.

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

• Yes, in the context of non-clinical device performance. The non-clinical tests described (EMC, ANSI/RESNA, ISO 7176) are standalone tests of the device's physical and electrical performance, without human "in-the-loop" assessment of functional outcomes (beyond standard operation for testing).

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

• The "ground truth" for the non-clinical performance testing was adherence to established engineering and performance standards (ANSI/RESNA WC-1, WC-2, ISO 7176) and compliance with the 1995 FDA Guidance Document for Mechanical and Powered Wheelchairs. These standards define the acceptable range of performance characteristics for such devices.

7. The sample size for the training set:

• Not applicable. There is no information about a "training set" as this is not a machine learning or AI device.

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

• Not applicable. There is no information about a "training set" or its ground truth.

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