(124 days)
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h. The braking time is about 2s, and the braking distance is ≤790m.
The provided text is a 510(k) Summary for a Powered Wheelchair (NXN20-205, NXN20-205M) and does not contain details about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
The document describes a traditional medical device (a powered wheelchair) and its substantial equivalence to a predicate device based on non-clinical testing against established ISO standards for wheelchairs. There is no mention of AI or machine learning in this report.
Therefore, I cannot provide the requested information, such as:
- Table of acceptance criteria and reported device performance for an AI/ML device: This document details performance specifications for a physical wheelchair (e.g., speed, range, loading capacity, stability), not AI/ML metrics.
- Sample size used for the test set and data provenance: No test set or data provenance for an AI/ML model is mentioned.
- Number of experts used to establish ground truth and qualifications: This is irrelevant for a physical powered wheelchair.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted as no AI assistance is involved.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of an AI/ML device.
- Sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document indicates that "Software Verification and Validation Testing" was performed in accordance with FDA Guidance for device software functions, but this refers to traditional software engineering validation, not AI/ML model validation with ground truth and performance metrics.
In summary, the provided text does not contain the information required to answer the prompt about acceptance criteria and studies for an AI/ML device.
§ 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).