(58 days)
It 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 Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever. speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The device discussed is a Mobility Scooter (Models: W3431D). Its acceptance criteria and performance are based on non-clinical testing against a series of ISO 7176 standards.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ISO Standard) | Performance/Test Results |
|---|---|
| ISO 10993-5: 2009 (Cytotoxicity) | All user directly contacting materials are compliant. |
| ISO 10993-10: 2010 (Irritation & Skin Sensitization) | All user directly contacting materials are compliant. |
| ISO 7176-1: 2014 (Static Stability) | The Static stability has been determined after testing and meets its design specification. |
| ISO 7176-2: 2017 (Dynamic Stability) | The dynamic stability has been determined after testing and meets its design specification. |
| ISO 7176-3: 2012 (Brake Effectiveness) | The effectiveness of brakes has been determined after testing and meets its design specification. |
| ISO 7176-4: 2008 (Energy consumption/Theoretical Distance Range) | The theoretical distance range has been determined after testing and meets its design specification. |
| ISO 7176-5: 2008 (Overall Dimensions, Mass, Maneuvering Space) | Dimensions and mass have been determined after testing. Results show the device has overall dimensions of 1020 mm x 500 mm x 840 mm and a base weight of 42kg (not including battery). |
| ISO 7176-6: 2018 (Max Speed, Acceleration, Deceleration) | The dimensions, mass has been determined after the testing according to ISO 7176-5 (note: document appears to repeat ISO 7176-5 for this item, but the standard title aligns with speed, acceleration, deceleration). Max Speed: 6 km/h. |
| ISO 7176-7 (Seating and Wheel Dimensions) | The seating and wheel dimensions have been determined after testing. Front wheel size: 190 x 55 mm; Rear wheel size: 190 x 55 mm; Arm Rests (Distance between armrests): 44-56 cm. |
| ISO 7176-8: 2014 (Static, Impact, Fatigue Strengths) | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9: 2009 (Climatic Tests) | The test results show that the device could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9. |
| ISO 7176-10: 2008 (Obstacle-climbing ability) | The obstacle-climbing ability of the device has been determined after testing. Slope Grade Ability: 9 degree. |
| ISO 7176-11: 2012 (Test Dummies) | The test dummies used in the testing of the ISO 7176 series meet the requirements of ISO 7176-11. |
| ISO 7176-13: 1989 (Coefficient of Friction of Test Surfaces) | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. |
| ISO 7176-14: 2008 (Power and Control Systems) | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| ISO 7176-15: 1996 (Information Disclosure, Documentation and Labeling) | The test results shown that information disclosure, documentation and labeling of the device meets the requirements of ISO 7176-15. |
| ISO 7176-16: 2012 (Resistance to Ignition) | The performance of resistance to ignition meets the requirements of ISO 7176-16. |
| ISO 7176-21: 2009 (EMC) | The EMC performance results meet the requirements of ISO 7176-21. |
| ISO 7176-25: 2013 (Batteries and Chargers) | The performance of batteries and charger of the device meet the requirements of ISO 7176-25. |
| General Performance Metrics | Max Loading (on level ground): 120kg; Turn Radius: 1650mm; Motor output: 24 V 180W; Drive System: Rear Wheel Drive; Brakes: Electromagnetic brake; Battery: Lead-acid 12V12Ah*2; Charger: 24V/2A; Time to brake: 0.7-1s; Brake Distance - Normal operation (Horizontal - Forward - Max speed): ≤1.5m; Travel Distance: 15 km/9.32 Miles. |
| Operating surface & environment | Indoor use and restricted outdoor use on pavements or paved footpaths only. |
The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device (K222507). These tests were performed in accordance with the specified ISO standards mentioned above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set. It refers to "the device" implying testing was done on one or more units of the Mobility Scooter (Models: W3431D). The tests are non-clinical, meaning they are likely engineering/performance tests on manufactured units, not studies involving human subjects or medical data. The provenance of the data is from Zhejiang Innuovo Rehabilitation Devices Co., Ltd, located in Dongyang, Zhejiang, China. The testing appears to be prospective in nature, performed on the device to demonstrate compliance.
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 is a non-clinical device safety and performance study. Therefore, the concept of "experts establishing ground truth for a test set" as would be used in a medical imaging or diagnostic device study is not applicable. The "ground truth" here is compliance with the engineering and safety standards (ISO 7176 series and ISO 10993 series). The evaluation would have been performed by qualified testing personnel and engineers, whose qualifications are not detailed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of non-clinical device performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective expert review of medical data. The tests performed are objective, quantitative measurements against established international engineering standards.
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 is a non-clinical submission for a mobility scooter, which does not involve "human readers" or "AI assistance" in the context of medical image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-driven device. It is a physical medical device (mobility scooter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is its compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The tests are designed to objectively measure the device's physical and mechanical properties and performance against the specified criteria within these standards.
8. The sample size for the training set
Not applicable. This is a non-clinical device performance and safety study for a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI or machine learning model in this submission.
§ 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).