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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 PL001 powered wheelchair 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. It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear drive wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel with connect cables and a electric motor controller. The device is powered by two 12 volt, 10 Ah, Li-ion batteries with 20 km(12.5 miles) range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz) when the device is not in use. The patient can activate the joystick to move in the direction of the joystick is actuated. When the patient releases the joystick the device slows to stop and the brakes are automatically re-engaged.

The provided text is a 510(k) summary for a powered wheelchair (PL001) and does not contain information about acceptance criteria or a study proving that an AI/algorithm device meets those criteria.

Instead, the document details the device description, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device (Ruike 3421). The non-clinical tests refer to compliance with various ISO and other standards relevant to powered wheelchairs, not for evaluating an AI or algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/algorithm device meets them based on this input.

Here's a breakdown of why each specific point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document lists standards (e.g., ISO 7176-1:1999) that the device complied with, implying these standards contain the acceptance criteria for a physical powered wheelchair. However, these are not acceptance criteria for an AI or algorithm, nor is there a direct table provided with pre-defined acceptance criteria and reported performance in an AI context.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no mention of a test set for an AI/algorithm, nor data provenance in that context. The "test set" here would relate to the physical device's validation against engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and experts are concepts relevant to AI model evaluation, not a physical wheelchair's safety and performance testing against engineering standards.
4. Adjudication method for the test set: Not applicable for the same reasons as above.
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. This type of study investigates the impact of AI assistance on human reader performance, which is irrelevant to a powered wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical powered wheelchair, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device's compliance is defined by the technical specifications and testing methods outlined in the cited ISO and other standards.
8. The sample size for the training set: Not applicable. There is no AI model or training set mentioned.
9. How the ground truth for the training set was established: Not applicable.

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DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.

The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about a study or acceptance criteria for an AI-powered device. Therefore, I cannot fulfill the request using the provided input.

The document is a standard 510(k) summary for a medical device (a manual wheelchair, Model DS 202-S) establishing substantial equivalence to a predicate device. It details:

• Device Name: DS 202-S manual wheelchair
• Intended Use: To provide mobility to physically challenged persons limited to a sitting position on flat and firm terrain, outdoor or indoor.
• Classification: Class I, Mechanical wheelchair
• Predicate Device: HUADONG HD11 manual wheelchair (K082274)
• Non-Clinical Testing: The device meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec. 5, Sec. 8, Sec. 15, Sec. 15, Sec. 16 and California Bureau of Home Furnishings 117. These standards are for mechanical wheelchair performance and safety.

The request, however, asks for information typically associated with the validation of AI-powered medical devices, including acceptance criteria tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and details of comparative effectiveness studies (MRMC) or standalone performance studies. None of this information is present in the provided text as the device in question is a manual wheelchair, not an AI device.

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