(387 days)
The UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.
The UPnRIDE™ device enables disabled and elderly individuals to be mobile in a sitting or standing position indoors and outdoors. The device design is based on the following principles: 1. Using motorized jointed braces and harnessing to safely support the user while sitting, shifting to standing, standing and returning to sitting - 2. Center of gravity (COG) is maintained substantially at the center of the device in all positions, thus maximizing stability and safety. - 3. Balancing the platform which supports the user so that the user always remains vertical even on skewed surfaces. - 4. Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs. The product is comprised of the following modules: - Driving module: a motorized driving chassis that 1. includes two front motorized wheels, two high capacity Li-Ion batteries 21.6VDC / 29.7Ah and a steel frame which is installed as a chassis for the device's components. - Inertial Measurement Unit ("IMU") for measuring 2. ground slopes (pitch and roll) and user's tilt angles (pitch and roll). - Standing and sitting module: a motor-based lifting 3. mechanism for shifting between standing and sitting positions. - 4. Balancing module: a platform that balances the user while sitting or standing, relative to earth. - 5. User interface module: a unit through which the user controls the UPnRIDE™. This module has an "R-NET" controller that contains a Joystick, commanding buttons and a display for viewing indications and status and a switching box for controlling the various modes of operation. - Actuator drivers: five units that control the lifting 6. motors. - 7. Main Controller: a unit which reads all sensors and user inputs, performs the balancing and safety algorithms, and controls all the chairs function.
The provided text is a 510(k) summary for the UPnRIDE stand-up power wheelchair. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Levo Comfort II and Quickie Q700-UP M) by comparing intended use, technical characteristics, and adherence to performance standards.
Here's how the requested information relates to the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present for an AI/ML component. The text lists voluntary standards (ISO series, ANSI/RESNA WC-1) that the UPnRIDE complies with, which are performance standards for wheelchairs in general, not specific acceptance criteria for an AI/ML algorithm's output.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as there's no AI/ML test set discussed. The document mentions "performance tests" and a "usability study" but provides no details on sample size, data provenance, or methodology for these.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical wheelchair with an "operation and safety algorithms" and a "Main Controller" that "performs the balancing and safety algorithms," but these are embedded control systems, not a standalone AI/ML diagnostic or predictive algorithm being evaluated for performance against a ground truth dataset in the way typically discussed in AI/ML reviews.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for an AI/ML component. The mention of "balancing operation was validated by multitude performance tests and a usability study" suggests physical performance and user experience were evaluated, not AI/ML output.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) premarket notification for a stand-up power wheelchair and does not include the type of detailed information about acceptance criteria and studies for an AI/ML device as requested. It focuses on demonstrating substantial equivalence to existing medical devices through technical comparison and compliance with relevant industry standards for wheelchairs.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).