(58 days)
The mobility Scoter 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 Mobility Scooter, Model S1 SPORT, S1 PLUS, MAX SPORT, has a base with Steel frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, 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 controller panel shape is slightly different among the three models, S1 SPORT, S1 PLUS, MAX SPORT. The S1 PLUS has a wind board on the triller, while the other two models do not have. The length of model MAX SPORT is 5cm longer than the other two models.
The provided document is a 510(k) premarket notification for a Mobility Scooter, not an AI/ML medical device. Therefore, the information typically required to describe the acceptance criteria and the study proving an AI/ML device meets those criteria (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not present in this document.
This document describes a traditional medical device (Mobility Scooter) and relies on non-clinical performance testing against recognized standards (ISO 7176 series and ISO 10993 series) and comparison to a predicate device to demonstrate substantial equivalence.
Based on the provided text, here's what can be extracted regarding the device's acceptance criteria and the study proving it meets them, adapting the requested categories to fit the context of this traditional medical device submission:
Device: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K Number: K231472
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this medical device are primarily adherence to established international standards for wheelchairs and mobility scooters. The reported device performance is that the device meets or conforms to these standards, thereby demonstrating substantial equivalence to the predicate device.
Table: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | All user-directly contacting materials are in compliance with ISO10993-5 requirements. |
| - ISO 10993-10:2010 (Tests For Irritation And Skin Sensitization) | All user-directly contacting materials are in compliance with ISO10993-10 requirements. |
| - ISO 10993-23:2021 (Tests for irritation) | All user-directly contacting materials are in compliance with ISO10993-23 requirements. |
| Electromagnetic Compatibility (EMC): | |
| - ISO 7176-21:2009 (Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters) | The EMC performance results meet the requirements of ISO 7176-21. |
| - IEC 60601-1-2:2014 (Electromagnetic Compatibility Testing) | Conforms to IEC 60601-1-2:2014. |
| Performance (ISO 7176 series): | |
| - ISO 7176-1:2014 (Static stability) | Static stability determined and test results meet design specification. |
| - ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Dynamic stability determined and test results meet design specification. |
| - ISO 7176-3:2012 (Effectiveness of brakes) | Effectiveness of brakes determined and test results meet design specification. |
| - ISO 7176-4:2008 (Energy consumption & theoretical distance range) | Theoretical distance range determined and test results meet design specification. |
| - ISO 7176-5:2008 (Dimensions, mass and maneuvering space) | Dimensions and mass determined. |
| - ISO 7176-6:2018 (Maximum speed, acceleration and deceleration) | Maximum speed, acceleration and deceleration determined. |
| - ISO 7176-7:1998 (Seating and wheel dimensions) | Seating and wheel dimensions determined. |
| - ISO 7176-8:2014 (Static, impact and fatigue strength) | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| - ISO 7176-9:2009 (Climatic tests) | 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) | Obstacle-climbing ability determined. |
| - ISO 7176-11:2012 (Test dummies) | Test dummies used in testing meet the requirements of ISO 7176-11. |
| - ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Coefficient of friction of test surfaces determined. |
| - 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) | Information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. |
| - ISO 7176-16:2012 (Resistance to ignition of postural support devices) | Performance of resistance to ignition meets the requirements of ISO 7176-16. |
| - ISO 7176-22:2014 (Set-up procedures) | All performed tests are set up as requirements of ISO 7176-22. |
| - ISO 7176-25:2013 (Batteries and chargers for powered wheelchairs) | Performance of batteries and charger meet the Requirements in Clause 5 and 6 of ISO 7176-25. |
| Labeling: | |
| - Conforms to FDA Regulatory | Conforms to FDA Regulatory. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation data. Instead, it refers to the Mobility Scooter device itself undergoing various non-clinical tests. It's implied that the device models (S1 SPORT, S1 PLUS, MAX SPORT) were subjected to these tests as representative units.
- Data Provenance: Not applicable in the AI/ML sense of retrospective/prospective clinical data. The "data" here are the results from the non-clinical performance and safety tests conducted on the physical device. The testing was conducted by or on behalf of the manufacturer, Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, typically refers to expert annotations or clinically confirmed labels on data. For a mobility scooter, "ground truth" is established by the physical testing against the measurable parameters of the ISO standards. The expertise lies in the certified labs and personnel conducting these standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among human annotators or readers for AI/ML ground truth. For this device, performance is measured against objective 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
- No. An MRMC study is a clinical study design used to evaluate diagnostic imaging AI. This is a physical mobility device, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is the objective, measurable criteria defined by the recognized international standards (ISO 10993 and ISO 7176 series). These standards define physical performance, safety, and biocompatibility limits.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product developed with a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm exists for this submission.
Summary of the study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance and safety tests conducted according to a comprehensive set of international standards, primarily the ISO 7176 series (for wheelchairs and mobility scooters) and the ISO 10993 series (for biological evaluation of medical devices). Additionally, Electromagnetic Compatibility (EMC) testing was performed according to IEC 60601-1-2.
The report details that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The results consistently demonstrated that the proposed device complies with and meets the requirements of these standards. The acceptance criteria for each test were the thresholds or specifications outlined within the respective ISO/IEC standards. The study concluded that, based on these non-clinical tests and comparisons to the predicate device, the subject device is as safe, effective, and performs as well as the legally marketed predicate device. No clinical studies were included 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).