(203 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 ZIPPY scooter consists of a retractable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a lead acid battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be retracted for transport in a car trunk.
The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
This is a submission for a motorized scooter, not an AI/ML powered medical device. As such, the requested information regarding AI/ML-specific study design, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, MRMC studies, and training/test set details, is not applicable and therefore not present in the provided text.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing against relevant standards.
Here's a breakdown of the available information based on your request, highlighting where the requested details are not applicable:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with various standards relating to wheelchairs and medical electrical equipment. Specific performance metrics (e.g., minimum range, maximum speed, stability under certain conditions) are implied by the standards but not explicitly detailed as acceptance criteria with numerical targets in this summary. | The ZIPPY scooter "complied with the requirements of ANSI/RESNA WC. Vol. I Sec. 7, Sec 8 and sec. 21, CISPR 11, IEC 60335-2-29, IEC 60601-1, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4. ISO 7176-5, ISO 7176-6, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 14971, ISO 10993-1. ISO 10993-5, and ISO 10993-10." |
2. Sample size used for the test set and the data provenance
- Not Applicable: This is a physical device (scooter), not an AI/ML algorithm that processes data. The "test set" would refer to the specific unit(s) of the scooter tested to ensure compliance with standards, and the provenance would be the manufacturing site (Dongguan Prestige Sporting Goods Co., Ltd. in China). The document does not specify the number of units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: For a physical device like a scooter, "ground truth" in the context of expert review for AI/ML performance is not relevant. Compliance with standards is typically assessed through engineering tests and measurements, often performed by certified testing laboratories.
4. Adjudication method for the test set
- Not Applicable: As above, adjudication methods like 2+1 or 3+1 are used for expert consensus on data labeling, which is not relevant for testing a physical mobility device.
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 device is a motorized scooter, not an AI system designed to assist human readers. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical device, not an algorithm.
7. The type of ground truth used
- Engineering/Performance Standards: The "ground truth" for this device is its adherence and demonstrable compliance with established international and national engineering standards (e.g., ANSI/RESNA WC. Vol. I Sec. 7, Sec 8 and sec. 21, CISPR 11, IEC 60335-2-29, IEC 60601-1, IEC 61000-4-2, etc.). This involves objective measurements and tests to ensure safety, functionality, and durability.
8. The sample size for the training set
- Not Applicable: This is a manufactured physical product. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set for this type of device.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).