(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: W3468A, has a base with Steal frame, two front wheels, 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 provided document is a 510(k) premarket notification for a Mobility Scooter (Model: W3468A). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical safety and effectiveness through extensive studies involving human subjects and AI performance metrics.
Therefore, many of the requested details, such as those related to AI algorithm performance, expert ground truth establishment, MRMC studies, or training set specifics, are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally that the Mobility Scooter (Model: W3468A) meets the specifications outlined in various ISO 7176 series standards and demonstrates performance comparable to the predicate device (K182471).
| Performance Measure/Test | Acceptance Criteria (Implicit: Meet standard requirements & be comparable to predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility (User-contacting materials) | Compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. |
| EMC | Compliance with ISO7176-21. | The EMC performance results meet the requirements of ISO 7176-21. |
| General Performance | Compliance with ISO7176 series. | Test results demonstrate compliance with ISO7176 series standards. |
| Label and Labeling | Conforms to FDA Regulatory requirements. | Conforms to FDA Regulatory. |
| ISO 7176-1 (Static Stability) | Meet design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. |
| ISO 7176-2 (Dynamic Stability) | Meet design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. |
| ISO 7176-3 (Brake Effectiveness) | Meet design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. |
| ISO 7176-4 (Theoretical Distance Range) | Meet design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. |
| ISO 7176-5 (Dimensions, Mass) | Determination of dimensions, mass. | The dimensions, mass has been determined after the testing according to the ISO 7176-5. |
| ISO 7176-6 (Max Speed, Acceleration, Deceleration) | Determination of max speed, acceleration, deceleration. | (Implicitly tested under ISO 7176 series, with specified Max Speed of 6.4km/h) |
| ISO 7176-7 (Seating and Wheel Dimensions) | Determination of seating and wheel dimensions. | The seating and wheel dimensions has been determined after the testing according to ISO 7176-7. |
| ISO 7176-8 (Static, Impact, Fatigue Strengths) | Meet requirements in Clause 4 of ISO 7176-8. | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9 (Climatic Tests) | Device continues to function according to manufacturer's specification. | The test results shown that the device under tests 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 (Obstacle-climbing ability) | Determination of obstacle-climbing ability. | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10. |
| ISO 7176-11 (Test Dummies) | Test dummies meet requirements of ISO 7176-11. | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. |
| ISO 7176-13 (Coefficient of Friction of Test Surfaces) | Determination of coefficient of friction. | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. |
| ISO 7176-14 (Power and Control Systems) | Meet requirements in Clauses 7-15, 17 of ISO 7176-14. | 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 (Information Disclosure, Documentation, Labeling) | Meet requirements of ISO 7176-15. | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. |
| ISO 7176-16 (Resistance to Ignition) | Meet requirements of ISO 7176-16. | The performance of resistance to ignition meet the requirements of ISO 7176-16. |
| ISO 7176-25 (Batteries and Chargers) | Meet Requirements in Clause 5 and 6 of ISO 7176-25. | The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or algorithm testing. The evaluation involved non-clinical testing against various ISO standards. These standards define the test conditions, procedures, and potentially the number of tests or samples (e.g., number of test cycles for fatigue, number of stability tests), but a single overarching "sample size" isn't provided.
- Data Provenance: The tests are "Non-clinical tests" conducted to verify design specifications and substantial equivalence. The document does not specify a country of origin for the testing data itself, beyond the applicant being from China. These are laboratory/engineering tests, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This submission does not involve AI performance evaluation or ground truth established by medical experts. The "ground truth" here is the adherence to established international safety and performance standards (ISO 7176 series) for mobility scooters. The experts involved would be engineers and testing personnel verifying compliance with these standards, not medical professionals establishing diagnostic ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There's no mention of an adjudication process in the sense of resolving discrepancies between expert opinions, as this is not a study involving human interpretation of medical images or data. The "adjudication" is the determination of whether the device met the requirements of the specified ISO standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This is a 510(k) submission for a physical medical device (mobility scooter), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no AI algorithm involved in this device.
7. The type of ground truth used
- The "ground truth" for this submission is based on engineering and performance standards (ISO 7176 series) and the demonstrated physical properties and function of the device meeting these standards. These are objective measurements and comparisons against established criteria for device safety and performance, rather than expert consensus on medical pathology or clinical outcomes.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI component requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI component requiring a training set or its associated ground truth establishment.
§ 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).