(254 days)
ATTO Mobility Scooter is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
ATTO Mobility Scooter is an electrical battery powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The ATTO is a collapsible electric scooter which has a front-wheel brushless DC hub motor. The scooter can be collapsed in 12 seconds and can also be disassembled with ease. The scooter controlled through a thumb throttle and protected by an electronic-release brake system, has a driving range up to 20 km between charges. It is capable of carrying a driver weighing up to 136 (for ATTO MAX) kg. It moves both directions and handles a 6° slope. It can come to a full stop within 1.1m when on a horizontal plane and within 2.2 m when on a 6° slope.
This document is a 510(k) summary for the ATTO Mobility Scooter and its variations (ATTO SPORT, ATTO SPORT MAX). It describes the device, its intended use, a comparison to a legally marketed predicate device, and the testing performed to demonstrate substantial equivalence.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "ATTO performance and safety testing is conducted according to EN 12184:2014. All Performance testing met the predetermined acceptance values." However, specific acceptance criteria values and the device's reported performance for each criterion are not explicitly listed in a table format within this submission. Instead, there's a comparison table (Section G) that shows some specifications for the proposed device and its predicate.
To extract acceptance criteria and reported performance, we can infer some from the predicate comparison and the standards mentioned. The document doesn't explicitly state "acceptance criteria" for each performance parameter but rather implies that the device met the requirements of the standards and performed as expected.
| Feature / Performance Parameter | Predicate ATTO Mobility Scooter (K160909) | Proposed ATTO Mobility Scooter (K222703) | Implied Acceptance Criteria (Based on comparison/standards compliance) | Reported Device Performance (K222703) |
|---|---|---|---|---|
| Max Load | 100 kg | 120 kg (ATTO, ATTO Sport), 136 kg (ATTO SPORT MAX) | Must meet or exceed predicate, and comply with safety standards for load capacity. | 120 kg (ATTO, ATTO Sport), 136 kg (ATTO SPORT MAX) |
| Maximum speed (forward) | 6.4 km/h | 6.4 km/h (ATTO, ATTO Max), 9.6 km/h (Max SPORT) | Must function as expected and be safe. Consistency or improvement over predicate. | 6.4 km/h (ATTO, ATTO Max), 9.6 km/h (Max SPORT) |
| Maximum speed (reverse) | 4 km/h | 4 km/h | Must function as expected and be safe. Consistent with predicate. | 4 km/h |
| Travel distance | 15 km | 20/17 km | Must meet or exceed predicate. | 20/17 km |
| Braking Time | Not publicly available | 0.5s | Must be safe and within acceptable limits for mobility scooters. | 0.5s |
| Braking Distance | Not publicly available | 1.1m (horizontal plane), 2.2m (6° slope) | Must be safe and within acceptable limits for mobility scooters. | 1.1m (horizontal plane), 2.2m (6° slope) |
| Slope handling | (Implied from general use) | Handles a 6° slope | Must enable safe operation on slopes as specified. | Handles a 6° slope |
| Full stop within | N/A | 1.1m (horizontal), 2.2m (6° slope) | Must comply with safety standards for braking effectiveness. | 1.1m (horizontal), 2.2m (6° slope) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size used for the test set" or the "data provenance" (country of origin, retrospective/prospective). The testing described is non-clinical performance and safety testing of the device itself, rather than a study involving human subjects or a dataset derived from patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The submission describes non-clinical performance and safety testing of a mobility scooter against engineering standards (ISO 7176 series and EN 12184:2014). It does not involve "experts" in the sense of medical professionals establishing a "ground truth" for a diagnostic or AI-driven decision. The "ground truth" here is adherence to technical specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As explained above, this is non-clinical device testing, not a diagnostic study requiring expert adjudication of ground truth.
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
This section is not applicable. The submission is for a mobility scooter, which is not an AI-assisted diagnostic device or one that involves human "readers" or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to national and international safety and performance standards (ISO 7176 series and EN 12184:2014) and the manufacturer's own design specifications, which are benchmarked against the predicate device. It's based on objective measurements and engineering principles, not medical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing pertains to the physical device.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set, there is no ground truth for it.
§ 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).