(12 days)
The intended use of the Buzzaround is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.
The intended use of the Buzzaround is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of overating a simple hand control.
The Buzzaround is a three wheeled battery powered scooter. It has a 70-amp controller, which is used to operate the Buzzaround. The two-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 scat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users weight over the rear wheels to aid in traction. All seating meets California Bulletin 117 fire standards. The Buzzaround comes standard with a compact removable 24-volt battery pack and on or off board charger and has an operating range of 10 to 15 miles on a full charge. The front and rear frames can be separated 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 4.5-mph
The provided submission K041025 is for a motorized three-wheeled vehicle (scooter) named Buzzaround. The acceptance criteria and the study performed for this device are focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, rather than clinical studies with human readers or AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/ML powered device, so there is no reported performance in terms of metrics like sensitivity, specificity, or AUC as might be seen for diagnostic algorithms. Instead, the acceptance criteria are met by demonstrating compliance with specific ANSI/RESNA performance standards for scooters.
| Acceptance Criteria (ANSI/RESNA Standard) | Reported Device Performance |
|---|---|
| WC/01 1990: Determination of Static Stability Testing | The device underwent and met the requirements of this standard. This is implied by the statement "Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:" followed by the list of standards, and the overall conclusion of substantial equivalence. |
| WC/02 1991: Determination of Dynamic Stability Testing | The device underwent and met the requirements of this standard. (Implied) |
| WC/03 1990: Determination of the Effectiveness of Brakes | The device underwent and met the requirements of this standard. (Implied) |
| WC/05 1990: Determination of Overall Dimensions, Mass, and Turning Space | The device underwent and met the requirements of this standard. (Implied) |
| WC/10 1990: Determination of Obstacle Climbing Ability | The device underwent and met the requirements of this standard. (Implied) |
| WC/Vol. 2-1998: Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters | The device underwent and met the requirements of this standard. (Implied) |
| Equivalence in Intended Use | "The Buzzaround has the same intended use..." |
| Equivalence in Technological Characteristics | "...and similar technological characteristics as the Companion 221." |
| No New Questions of Safety or Effectiveness | "non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Weight Capacity | 300 lbs (Stated in device description) |
| Maximum Speed | 4.5 mph (Stated in device description) |
| Seating Fire Standards | Meets California Bulletin 117 fire standards (Stated in device description) |
| Operating Range | 10 to 15 miles on a full charge (Stated in device description) |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail a "test set" in the context of clinical data for AI/ML validation. The "testing" referred to comprises non-clinical performance tests conducted on the physical device itself. Therefore, a sample size of human subjects or medical images for a test set is not applicable. The data provenance is from the results of a series of engineering and performance tests on the Buzzaround device according to specified industry standards (ANSI/RESNA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable as the ground truth for this type of device (a mobility scooter) is established through adherence to engineering standards and safety tests, not through expert review of clinical data. The "ground truth" here is the physical performance and safety characteristics of the device when subjected to standardized tests.
4. Adjudication Method for the Test Set
This question is not applicable for the reasons stated above. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated, either with or without AI assistance. The Buzzaround is a physical mobility device, not a diagnostic tool or AI algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The Buzzaround is a physical medical device, not a software algorithm, so the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily engineering and performance standards compliance. Specifically, the device's performance was compared against the requirements stipulated in:
- ANSI/RESNA WC/01 1990 Determination of Static Stability Testing
- ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing
- ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes
- ANSI/RESNA WC/05 1990 Determination of Overall Dimensions, Mass, and Turning Space
- ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability
- ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
The "ground truth" also includes the design specifications and features of the predicate device (Companion 221, K012258) for comparison of substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. The Buzzaround is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
§ 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).