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The e-motion M25 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

The e-motion-M25 is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility.

To extend functionality an optional remote control (ECS) and a Smartphone App is available.

The user interacts with the e-motion M25 via push-rim that triggers the assistive power drive.

The main parts of the drive unit are as follows:

• Pushrim-wheels including a brushless DC-motor .
• Control Electronic for the motor and wireless interface for communication with ECS and . smartphone App
• . Integrated lithium ion battery pack with battery management system
• Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger
• Quick-release axle for attaching and detaching the drive unit to wheelchair-frame .

The main function of the APP are as follows:

• Status information (Battery, Speed)
• Live display of error messages ●
• Recording of tours
• Selection of preset driving profiles ●
• ECS-Funtionality (extra charge , details see below) ●
• Wheelchair navigation (extra charge)
• Enhance maximum speed (extra charge) ●
• . Cruise Mode (extra charge)
• Activation flight mode ●
• System information ●
• Error logfile (password protected)
• Setting auto shut-off time (password protected) ●
• Inidivial adjustment of driving parameters (password protected) ●

The main function of the ECS are as follows:

• Drive-Mode
• Settings ●
• Diagnostics ●

To charge the battery of the drive unit a battery charger is available. Main attributes:

• . Multi-range charger 100-240 VAC, 50-60 Hz
• . Automatic charging and switch-off mechanism
• Indicating status and mains ●

The provided text is a 510(k) Summary for the e-motion M25, a power assist wheelchair conversion kit. It describes the device, its intended use, comparison to predicate devices, and conformity with recognized standards. However, it explicitly states:

"Clinical tests were not conducted."

This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance. The focus of this 510(k) submission is on demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This would be based on clinical study outcomes, which are absent.
2. Sample size used for the test set and the data provenance: No clinical test set data is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with ground truth was established from expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a medical imaging-specific study type and not relevant to a powered wheelchair accessory.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document emphasizes non-clinical tests to demonstrate safety and efficiency, including mechanical, electrical, and biological safety, as well as performance aspects, all in conformity with recognized standards (e.g., ISO 7176 series for wheelchairs). The "acceptance criteria" here would be meeting the specifications outlined in those standards and demonstrating substantial equivalence to the predicate devices.

In summary, the provided document does not describe a clinical study or a study directly proving the device meets acceptance criteria through clinical performance data.

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