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The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The A08 power wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. The A08 power wheelchair is with a 100 kg (220 lbs) weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors (250 W, DC 24V) drive system, electromagnetic braking system, electric motor controller (Yisheng Electric Co., Ltd., Model: WS-1) and two Li-ion batteries with an off-board battery charger (2 A). It is powered by two 12 volt Li-ion DC batteries with 20 km (12.5 miles) with 20 Ah which maximum speed upto 7 km/hr (4.4 mph). The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.

The provided document is a 510(k) premarket notification for a power wheelchair (A08) and focuses on establishing substantial equivalence to a predicate device (PL001, K113463). It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance.

The document describes a medical device (a power wheelchair) that has undergone non-clinical testing to comply with various ISO and IEC standards. These standards typically relate to the safety, performance, and construction of such devices, not to AI/ML software performance or diagnostic accuracy.

Therefore, I cannot extract the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance: The document only lists a series of ISO/IEC standards that the device "complied with," but does not provide specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for an AI/ML algorithm or the numerical performance results against those criteria.
• 2. Sample size used for the test set and the data provenance: Not applicable as no AI/ML performance study is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document is purely a regulatory submission for a physical medical device, demonstrating its equivalence to an existing device based on mechanical, electrical, and safety standards. It does not involve any AI/ML components or associated performance studies.

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