(360 days)
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
A battery operated lightweight portable mobility device designed for personal travel indoors and limited outdoor use and available in 4 wheel configurations. It is used in a sitting position and operated by a hand controlled throttle located on the handle bars. Braking is automatically controlled when releasing the throttle by the electronic controller and magnetic motor brake. The product is supplied ready to use with a battery and charger and it can be disassembled and folded for transport. Steel frame, battery cycle life of Sealed Lead Acid battery is 400 charging times, 24V15ah Lithium battery is 1000 charging times, 24V12ah Lithium battery is 800 charging times.
The provided document is a 510(k) summary for the "SupaScoota" Motorized Vehicle, Spartan (Sumo) / Spartan SP (Sumo SP). It details the device's characteristics and its substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for AI-related software. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details cannot be extracted from this document.
However, I can provide information based on the listed non-clinical testing performed to establish safety and effectiveness for this type of medical device (a motorized vehicle).
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" for each criterion. However, it lists several ISO 7176 standards that the device underwent testing for. The general acceptance criterion implied is compliance with these standards. The document states: "All test results are in compliance with it and were similar to predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 7176-1: Static stability test | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-2: Dynamic stability test | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-3: Efficiency of brakes tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-4: Theoretical distance range tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-5: Overall dimensions, Mass, Turning, Diameter tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-6: Maximum speed, acceleration and retardation tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-7: Seating and wheel dimension tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-8: Static, impact and fatigue strengths tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-9: Climatic tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-10: Obstacle-climbing ability tests | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-11: Test dummies | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-13: Determination of coefficient of friction of test surfaces | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-14: Power and control system | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-15: Information disclosure, documentation and labeling | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-16: Resistance to ignition of postural support devices | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-21 (EN 12184): EMC test | All test results are in compliance and similar to predicate device. |
| Compliance with ISO 7176-25: Batteries and chargers for powered wheelchairs | All test results are in compliance and similar to predicate device. |
| Compliance with IEC 62133: Secondary cells and batteries safety requirements | All test results are in compliance. |
| Compliance with ISO 10993-5: Tests for In Vitro cytotoxicity | All test results are in compliance. |
| Compliance with ISO 10993-10: Tests for irritation and skin delayed-type hypersensitivity | All test results are in compliance. |
| Max Loading (on level ground) 200kg (440 lbs) | Passed the loading test (stated implicitly in comparison table). |
| Brake distance-Normal operation (Horizontal-Forward-Max speed) 1.0-1.5 m/s | 1.0-1.5 m/s |
| Time to brake (1 | 0.6~0.9 seconds |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a 510(k) summary for a physical device. Non-clinical testing typically involves specific test samples of the device and its components. "Data provenance" as typically understood in AI studies (e.g., country of origin of data, retrospective/prospective) is not applicable here as these are performance tests of the device itself.
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 is not applicable. The "ground truth" for the non-clinical tests of a motorized vehicle are established by the international standards (ISO) themselves through defined testing methodologies and equipment, not by human experts evaluating outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no expert adjudication for the performance of a physical device against engineering standards.
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 is not applicable. This document describes a physical motorized medical device, not an AI or software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document is about a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests of this motorized vehicle is defined by the technical specifications and performance requirements outlined in the referenced ISO and IEC standards. For example, for "Static stability test" (ISO 7176-1), the ground truth is simply whether the device remains stable under defined static conditions.
8. The sample size for the training set
This is not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This device is not an AI/ML algorithm.
§ 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).