(63 days)
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
The Empulse R90 is an auxiliary power module to provide augmented power to manual wheelchair users. The device utilizes a single electric drive wheel to provide the augmented power. The device mounts to a camber tube (rigid wheelchair) or a compressible axle (folding wheelchair) to provide the assisted power. On-board sensors, including an inclinometer, accelerometer and motor current sensing to determine when the user wishes to move forward and if the system is on an incline or decline. The removable Lithium lon battery pack is easily switched out to an alternate battery pack if additional range is required. The battery can also be removed if the user wishes to reduce the overall weight. The actuator is used to automatically engage and disengage the locking latch as well as compress the pre-load traction spring when the user wishes to disconnect the EMPULSE R90 from the wheelchair. In the extended position, the actuator allows the pre-load spring to provide sufficient pre-load to the drive wheel to ensure sufficient traction.
The provided text is a 510(k) Premarket Notification for a medical device called "Empulse R90", a power assist device for manual wheelchairs. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request for the specific information regarding AI/ML device acceptance criteria and study details. The document pertains to a physical medical device and its equivalent performance to existing physical predicate devices through non-clinical mechanical, electrical, and performance testing, rather than an AI/ML diagnostic or predictive tool.
§ 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).