(27 days)
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
| Acceptance Criteria Category | Specific Criteria (Derived from device specifications & safety info) | Reported Device Performance / Specification |
|---|---|---|
| Functional Performance | Maximum User Weight | 150 kg (Subject device & predicate e-motion M25) |
| System Weight | 15.85 kg (Subject device) | |
| Nominal Power | 2x80W (Subject device & predicate e-motion M25) | |
| Max. Assisted Speed | 6...8.5 km/h (Subject device & predicate e-motion M25) | |
| Nominal Range | 25 km (Subject device & predicate e-motion M25) | |
| Power Wheel Range | up to 25 km (as per ISO 7176-4) | |
| Nominal Gradient | 16% [9°] | |
| Operating Temperature | -25° C to +50° C | |
| Battery Type (Drive Unit) | Lithium-ion 10ICR19/66-2 | |
| Rated Operating Capacity (Drive Unit) | 36.5 V | |
| Rated Capacity (Drive Unit) | Ah (Value not specified beyond unit) | |
| Rated Energy (Drive Unit) | Wh (Value not specified beyond unit) | |
| Control Unit Battery Type | Lithium-ion 18650 | |
| Control Unit Rated Voltage | 3.6 VDC | |
| Control Unit Rated Capacity | 2.6 Ah | |
| Control Unit Rated Energy | 9.36W | |
| Wireless Communication | Wireless Technology (Power Unit) | IEEE 802.15.4 (BLE & Classic) |
| RF Freq Range (Power Unit, ECS, Control Unit) | 2.402 GHz to 2.480 GHz | |
| Max Output Power (Power Unit) | 1.5dBm | |
| Max Output Power (ECS, Control Unit) | 5dBm | |
| Wireless Operating Range | 10m / class 2 | |
| Wireless Coexistence Compliance | ANSI C63.27-2017, separation distance >0.25m (Power Unit, ECS, Control Unit) | |
| EMC Compliance | ISO 7176-21:2009 (Power Unit, ECS, Control Unit) | |
| Safety - Cybersecurity | SweynTooth Vulnerability Mitigation | All wireless communication encrypted. |
| Response to successful attack (Normal drive mode) | No influence on driving behavior; device acts independently. | |
| Response to successful attack (Cruise Mode, Remote Mode) | Motor driving support stops to enter safe state (no auxiliary power); unintended movements impossible. | |
| Safety - General | User Interaction | Via two push-rims; optional remote control (ECS), smartphone app, detachable control unit. |
| Compliance with wheelchair manufacturer limits | User must observe wheelchair manufacturer's limits (gradeability, obstacles, user weight, etc.). |
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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).