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The e-motion M25 DuoDrive 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 DuoDrive 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) a smartphone app and a detachable control unit is available. The user interacts with the e-motion M25 DuoDrive via two push-rims that trigger 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 remote control 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 functionality (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). Individual adjustment of driving parameters (password protected). The main function of the ECS remote control are as follows: Switch between 2 assist level for indooir and outdoor. Selection of learner mode (formerly also called Training mode). Activation of rollback delay (hill holder). Switch the wheels on and off (standby mode). The main parts of the control unit are as follows: Wireless interface for communicating with the drive wheels. Rotary wheel to start and change the cruise speed. Rotary wheel to stop cruise mode (short push on the side). Rotary wheel to switch the drive wheels on and off/standy mode (long push on the side). Integrated Li-ion battery cell including battery management system. USB-C socket for charging via drive unit or other external USB-C charger. Display for operating status and remaining capacity of drive wheels and control unit. 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.

This document describes the premarket notification (510(k)) for the e-motion M25 DuoDrive, a power assist wheelchair conversion kit. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

The information provided does not outline specific acceptance criteria or a detailed study proving the device meets those criteria in the typical sense of a clinical or analytical performance study for an AI/ML-driven medical device. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (e-motion M25 (K192618) and SMOOV O10 (K192016)) by comparing technical specifications, intended use, and addressing potential changes (like the addition of a control unit).

Therefore, I cannot directly provide the requested table of acceptance criteria and reported device performance related to an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). This device is a mechanical/electronic medical device, not an AI/ML diagnostic or prognostic tool.

However, I can extract the relevant information regarding the device's functional and safety characteristics, which serve as its "performance" and "acceptance criteria" in the context of this 510(k):

Acceptance Criteria and Device Performance (Based on Device Specifications and Safety Considerations)

Since this is a mechanical/electronic device, "acceptance criteria" here refer to its technical specifications and demonstration of safety/effectiveness compared to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is more applicable to AI/ML software as a medical device (SaMD) performance studies:

This 510(k) pertains to a mechanical/electronic power assist device, not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies for its core function. Therefore, the following points are not applicable to this specific submission.

2. Sample sized used for the test set and the data provenance: Not applicable for this type of device. Testing would involve engineering performance tests (e.g., battery life, speed, durability) and safety testing for electrical and mechanical hazards, not a "test set" of data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device would be established through engineering specifications, standards compliance, and physical testing, not expert interpretation of data.

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: Not applicable. This device does not involve "human readers" or AI assistance in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no standalone AI algorithm in the context of device performance outlined here. The device itself is a "human-in-the-loop" system, assisting a human wheelchair user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering specifications, international performance and safety standards (e.g., ISO 7176-4, ISO 7176-21), and physical testing (e.g., speed, range, weight capacity, electrical safety, EMC). The "change information" notes that the changes were made under their "design control process," which would involve verifying that the updated design still meets these established specifications and safety requirements.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established: Not applicable.

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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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