(345 days)
The TWIST and TWIST R are add-on drive accessories for wheelchairs.
The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.
TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.
The TWIST and TWIST R are add-on drive accessories for wheelchairs. The main parts of the drive unit include a drive wheel with a brushless motor and tire, an Electronic Control Unit (ECU), a removable lithium ion battery pack, an On/Off button and indicators, a carrying and release handle, a battery charger, front and rear lights, and locking pins. The controller includes a wireless interface, On/Off button, battery level LEDs, speed selection lever and brake button, integrated Li-ION battery cell, and a USB-C socket. The handlebar unit includes a wireless interface, On/Off button, battery level LEDs, accelerator, brake levers, integrated Li-ION battery cell, and a USB-C socket.
The provided text focuses on the K240267 510(k) Summary for the Klaxon TWIST and TWIST R add-on drive accessories for wheelchairs. While it details numerous technical specifications and non-clinical testing standards, it does not include acceptance criteria, performance data against those criteria, or information about a study that proves the device meets specific performance targets in the way typically required for AI/ML medical devices.
Instead, the document asserts substantial equivalence to a predicate device (SMOOV O10) based on similar indications for use, intended use, and demonstration of safety and performance through adherence to recognized standards.
Therefore, I cannot populate the table or answer most of the questions using only the provided text as it pertains to AI/ML device performance and acceptance criteria. The device described is a physical powered wheelchair accessory, not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of what can be extracted and why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document in the context of acceptance criteria and performance results for an AI/ML device. The document lists numerous technical specifications for the device (e.g., max speed, motor power, battery capacity, weight), and declares compliance with various ISO and other standards (listed in section 4). However, it does not provide specific acceptance criteria (e.g., "The device must achieve an accuracy of X% for Y task") nor reported performance against such criteria for an AI/ML algorithm.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable/not provided as the device is a physical powered wheelchair accessory, not an AI/ML device that requires a test set of data for algorithm performance evaluation. The "testing" referred to is non-clinical, related to physical and electrical safety and performance standards of the hardware.
3. 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):
This information is not applicable/not provided for the same reason as point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the same reason as point 2.
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 information is not applicable/not provided as the device is not an AI-assisted diagnostic or prognostic tool used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided for the same reason as point 2 and 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided for the same reason as point 2. The "ground truth" for this type of device would be mechanical, electrical, and safety standards verified through engineering tests.
8. The sample size for the training set:
This information is not applicable/not provided as the device is a physical product and does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the same reason as point 8.
§ 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).