(104 days)
The Ruike 3431 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The Ruike 3431 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided document is a 510(k) Summary for a medical device (Ruike 3431 scooter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) Summary for a device like this.
Specifically:
- Acceptance Criteria and Reported Device Performance: Instead of explicit acceptance criteria being met by a study, the document presents a comparison to a predicate device (Bewell SC 20). The "performance" is described through the device's technical specifications and intended use, and the claim is that minor differences do not alter the intended function or raise new safety/effectiveness questions.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Study, Training Set: These are all concepts related to clinical or performance studies designed to validate the efficacy or accuracy of a device, especially those involving AI or diagnostic capabilities. The Ruike 3431 scooter is a mobility device, and its approval process relies on demonstrating that it is as safe and effective as pre-existing, legally marketed devices (the predicate). This usually involves engineering tests (e.g., maximum loading, speed, braking distance) and a comparison of specifications, not clinical trials with human subjects to establish ground truth or measure improvements with AI assistance.
However, I can extract the comparative performance table that serves as the basis for demonstrating substantial equivalence:
1. Table of Acceptance Criteria (or Comparison to Predicate) and Reported Device Performance
Instead of "acceptance criteria" against which a study directly validates, the 510(k) process for this device relies on demonstrating "substantial equivalence" to a predicate device. The performance comparison is therefore presented in relation to the predicate.
| Feature | Predicate Device: Bewell SC 20 (K043326) | Ruike 3431 (Reported Performance) |
|---|---|---|
| Intended Use | Both scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. | Same as predicate. |
| Maximum Loading | 130 kg (286 lbs) | 120 kg (265 lbs) |
| Overall Height | 1120 mm (44") | 825 mm (32.5") |
| Overall Length | 1300 mm (51.2") | 1030 mm (40.6") |
| Overall Width | 610 mm (24") | 510mm (20") |
| Seat Overall Height | 370 mm (14.5") | 430 mm (16.9") |
| Seat Overall Width | 450mm (17.7") | 500 mm (19.7") |
| Seat Overall Depth | 450mm (17.7") | 400 mm (15.7") |
| Seat Overall Weight | 7.5 kg (16.5 lbs) | 10 kg (22 lbs) |
| Motor Output | DC24V, 700W, 5000 RPM, 1Pc | 180 W x DC 24V, 1Pc |
| Controller | Dynamic DS72K01 | PG S-Drive 45A |
| Differential Mechanism | Differential rate: 20 : 1 | Differential rate: 17 : 1 |
| Rear Wheel Drive | (Not specified as a distinct feature) | Sealed transaxle direct drive |
| Front Wheel | 4" Pneumatic tire × 2 Pc | 195 mm x 80 mm (7.6"x 3.15") Solid tire x 2 |
| Rear Wheel | 4" Pneumatic tire × 2 Pc | 195 mm x 80 mm (7.6"x 3.15") Solid tire x 2 |
| Charger | Yes, 4V 5AMP (Automatic Type) off-board | 24V 5AMP charger (Automatic Type) off-board |
| Battery | Lead-Acid 12V × 36AH × 2PCs | Lead-Acid 12V×24AH×2 |
| Battery level indicator | (Not specified) | Yes |
| Tiller Foldable | Yes | Yes |
| Rear suspension | No | Yes (Optional) |
| Continuous height adjustab | (Not specified) | Yes |
| Backrest recline angle | (Not specified) | Yes |
| Recline angle | (Not specified) | Yes |
| Operation model | Thumb operated potentiometer throttle control | Thumb operated potentiometer throttle control |
| Warning Ligh(Rear) | No | Yes |
| Tail lights | No | Yes |
| Headrest | (Not specified) | Yes |
| Armrests | Yes | Yes |
| Bumpers | Front: Yes, it's constructed by steel | Front/Rear: Yes, it's constructed by steel |
| Maximum speed | 0 to 9 km/hr (5.6 mph), variable | 0 to 6 km/hr (3.7 mph), variable |
| Turning radius | 1500 mm (59") | 1050 mm (41.3") at max speed |
| Maximum curb over-charge distance | 127 mm (5.0") | 45 mm (1.8") |
| Slope grade ability | 12 degree | 12 degree |
| Braking distance | Standard: 2.58 m(101.6") at max speed | Standard: 1000 mm (39.4") |
| Brake system | Front: Yes, Rear: No (Not specified further) | Intelligent regenerative electromagnetic brake |
| Net weight with battery | 96 kg (213 lbs) | 51 kg (112 lbs) |
| Continuous range | 22 to 35.2 km (22 miles) | 15 km (9 miles) |
| Speed mode | Single mode, Variable | Single mode, Variable |
| Disassemble | No | Yes |
| Horn | Yes | Yes |
Since this is a 510(k) submission for a non-diagnostic, non-AI device like a scooter, the following requested information is not applicable and would not be found in such a regulatory document:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).