(15 days)
The intended use of the Golden Liteway is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
The intended use of the Golden Liteway is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of operating a simple hand control.
The Golden Liteway is a three wheeled battery powered scooter. It has a 45-amp controller, which is used to operate the Golden Liteway. The one-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable fold down seat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users' weight near the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Golden Liteway comes standard with a compact removable 24-volt battery pack with auto contact and lock and an off board charger. The Golden Liteway has an operating range of 7.5 miles on a full charge at Maximum weight of 300 lbs. The frame can be separated from the rear wheel assembly for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4-mph.
The Golden Liteway is a three-wheeled battery-powered scooter intended to provide mobility to persons limited to a seated position who are capable of operating an electric scooter. The submission is a 510(k) premarket notification, and therefore, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the document addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) summary demonstrating substantial equivalence to a predicate device (the Buzzaround, K041025) and not a de novo clearance or PMA submission for a novel device, the "acceptance criteria" are primarily established by conformity to relevant industry standards and comparison to the predicate. The performance reported focuses on meeting these standards and having similar characteristics to the predicate.
| Acceptance Criterion (Standard/Characteristic) | Reported Device Performance (Golden Liteway) |
|---|---|
| ANSI/RESNA WC/05 1990 | |
| Determination of overall Dimensions, Mass and Turning Space | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| EN 12184 With Reference to: | |
| EN 55022(B) Emissions | |
| IEC 61000-4-3 Immunity | |
| IEC 61000-4-2 ESD | All EMC tests performed and compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-2 (ANSI/RESNA WC/Vol. 2-1998 Section 2) | |
| Dynamic Stability Testing | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-1 | |
| Static stability testing | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-4 | |
| Energy Consumption of Electric Wheelchairs and Scooters for determination of theoretical distance range | Operating range of 7.5 miles on a full charge at maximum weight of 300 lbs. |
| ISO 7176-6 | |
| Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Maximum speed of 4-mph |
| ISO 7176-10 | |
| Determination of obstacle climbing ability of electric wheelchairs | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-9 2001 | |
| Climatic Tests for wheelchair | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| ISO 7176-8 (1998) | |
| Requirements and test methods for static, impact and fatigue strengths | Compliant (implied by inclusion in non-clinical tests to demonstrate substantial equivalence) |
| TB117 Flammability test (1) SEC. A Part I | |
| Flame Retardance Test | All seating meets California Bulletin 117 fire standards. |
| Predicate Device Equivalence (Buzzaround, K041025) | Controlled by paddle type potentiometer, onboard batteries/charger, equivalent safety features, same intended use, similar technological characteristics. |
| Weight Capacity | 300-lbs |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "test set" in the context of clinical trials or AI/algorithm performance. The non-clinical tests refer to standardized testing of mechanical and electrical components, not typically involving distinct "test sets" of patient data or users.
- Data Provenance: Not applicable in the context of this 510(k) for a mobility scooter, as it relies on engineering and performance standards rather than clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission concerns a physical medical device (scooter) and relies on engineering standards and technical specifications rather than expert interpretation of medical images or data.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, this involves technical standards and physical product testing, not subjective expert adjudication.
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 not an AI-enabled device requiring MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering and safety standards (e.g., ISO, ANSI/RESNA, EN, California Bulletin 117). Compliance with these standards serves as the benchmark for acceptable performance. The performance characteristics of the predicate device also serve as a "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm device.
Summary of the Study and Substantial Equivalence:
The study proving the device meets its acceptance criteria is a series of non-clinical engineering tests (as listed in Section {1} and {2}) and a comparison to a predicate device. The Golden Liteway demonstrates its substantial equivalence to the predicate device, the Buzzaround (K041025), by:
- Having the same intended use: providing mobility to persons limited to a seated position capable of operating an electric scooter.
- Possessing similar technological characteristics: both are controlled by a paddle-type potentiometer, have onboard batteries and chargers, and equivalent safety features.
- Successfully undergoing a battery of non-clinical tests (e.g., stability, energy consumption, speed, flammability, EMC) according to recognized international and national standards (ANSI/RESNA, EN, ISO, TB117). The successful completion of these tests implicitly demonstrates compliance with the safety and performance requirements of these standards.
The conclusion is that the differences in technological characteristics of the Golden Liteway compared to the Buzzaround do not raise any new questions of safety or effectiveness, thus establishing substantial equivalence. No clinical trials were performed or deemed necessary 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).