(186 days)
The Moving Life 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 of 15 km between charges. It is capable of carrying a driver weighing up to 100 kg. It moves in both directions, and can handle 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.
The provided text is a 510(k) summary for the ATTO Mobility Scooter. It aims to demonstrate substantial equivalence to a predicate device, the Luggie Mobility Scooter, rather than proving the device meets acceptance criteria through clinical or standalone performance studies against a predefined ground truth.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from this document, as these types of studies were not performed or are not detailed in this submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for specific performance metrics of the device against which it was tested. Instead, it states that "All Performance tests met the predetermined acceptance values" without listing those values or the corresponding reported device performance metrics. Its primary comparison is to a predicate device.
What is available: The document compares some technological characteristics and performance parameters to the predicate device in Section F. However, these are not presented as "acceptance criteria" for the ATTO Mobility Scooter itself, but rather as comparative attributes.
| Model | ATTO Mobility Scooter | Luggie (Predicate) |
|---|---|---|
| (General Statement) | All Performance tests met the predetermined acceptance values. The Moving Life ATTO Mobility Scooter functioned as intended and its functionality observed was as expected. | N/A (Predicate, used for comparison) |
| Specific Performance/Characteristics (for comparison): | ||
| Max load | 100 kg | 114 kg / 250 pounds |
| Required width of angled corridor | 1000 mm | 762 mm |
| Turn radius | 135.0 cm | 103.75 cm / 40.85 inches |
| Maximum speed (forward) | 6.4 km/h | 6 km/h |
| Maximum speed (reverse) | 4 km/h | 3.52 km/h |
| Travel distance | 15 km | 18 km |
| Stop distance (horizontal plane) | 1.1m (mentioned in Device Description) | Not explicitly stated for Luggie, but implied similar braking principles. |
| Stop distance (6° slope) | 2.2m (mentioned in Device Description) | Not explicitly stated for Luggie, but implied similar braking principles. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. The document describes non-clinical testing against ISO standards and comparison to a predicate device. It does not refer to a "test set" in the context of clinical data or AI/ML performance evaluation.
- Data Provenance: Not applicable/Not provided. The testing refers to engineering and quality assurance tests on the device itself, not data collected from patients or users in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts is mentioned, as this is a submission for a physical mobility device based on substantial equivalence and non-clinical testing, not an AI/ML algorithm requiring expert annotations or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There's no test set requiring ground truth adjudication in this context.
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 a physical mobility device, not an AI-assisted diagnostic or clinical decision support system. No human reader studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance relies on engineering specifications and compliance with relevant ISO standards for medical scooters, demonstrated through non-clinical testing. It is not clinical "ground truth" derived from patient data.
8. The sample size for the training set
Not applicable. No "training set" is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable. No "training set" or corresponding ground truth establishment is discussed for this device.
Summary of available information:
The document primarily focuses on demonstrating substantial equivalence of the ATTO Mobility Scooter to a predicate device (Luggie, K110165) based on:
- Similar intended use and indications.
- Similar technological characteristics and principles of operation.
- Non-clinical testing conducted in accordance with ISO 7176 standard series (including sections 2, 3, 4, 5, 6, 7, 9, 10, 11, 13, 14, 15, 16, and 21) and IEC 62133 for battery and charger.
- The statement that "All Performance tests met the predetermined acceptance values."
Crucially, the submission states "No clinical testing is included in this submission." This means that traditional clinical trials or studies involving human subjects to establish performance or ground truth were not part of this 510(k) submission. Therefore, detailed information related to clinical study design, sample sizes, expert adjudication, or AI/ML specific performance metrics cannot be derived from this document.
§ 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).