Search Results

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.

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device