(258 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Auto Folding Scooter S21F is designed for indoor use for adults with mobility restrictions. It is classified as Class II medical device per US FDA 21 CFR 890.3800. It is compact, maneuverable and not necessarily able to overcome obstacles. The maximum load is 115 kg. The product is not intended for visually impaired people. The drivers need to be mentally and physically suitable to drive the scooters. The fingers need to work functionally. The driving distance will be reduced if the scooter is used frequently on slopes, rough ground or climbing curb. The scooter is not for use as a seat in motor vehicle. Auto Folding Scooter S21F is battery powered and configured with four solid wheels (03) (08), a seat (04), a handle bar to control the driving function (01), a cross bar (05), a main frame (06), a foot-rest (02), a back-rest (04), a set of 2 anti-tippers (09), referred to the components and parts diagrams of S21F below. S21F is driven by two solid rear wheels (08) as the drive wheel, two solid front castors (03) as the steering wheel, using the steering handles (01) to control the front frame assembly (02) to control the front wheels (03) as the power scooter steering direction mechanism. Steering handles (01) is able to control driving forward, driving backward, speed control. The main frame (06) is equipped with a rear bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. The maximum loading weight of S21F is 253 lbs. (115 kg), and its maximum speed is 3.75 mph (6 km/h). The dimensions of (Length * Width *Height) of the unfolded device are 33.0" x 18.1" x 30.3" (840 mm x 460 mm x 770 mm) and 28.7" x 17.3" x 16.5" (730 mm * 420 mm * 420 mm) for the folded device. The weight of the device is 51.8 lbs. (23.5 kg) with battery and 46.9 lbs. (21.3 kg) without battery. Seat belt is a standard accessory to S21F power scooter, and is not a 510(k)-clearance accessory. It can be installed onto the seat (as seen in the diagram below) by consulting with the local authorized dealer for seat belt installation.
This document describes the premarket notification for the "Auto Folding Scooter, S21F" and does not contain information about an AI/ML medical device. Therefore, a study proving a device meets acceptance criteria for such a device is not applicable. The information provided heavily focuses on the safety and performance of a physical medical device (a motorized scooter) as compared to a predicate device, based on engineering standards and physical testing, rather than a clinical study of an AI algorithm.
However, I can extract information related to product acceptance and testing mentioned for this physical device:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance (S21F) |
|---|---|
| EMC Standards | |
| ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test method for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Passed |
| RESNA WC-2:2019 Section 21: 2009 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters | Passed |
| Electrical Safety Standards (for charger: METCO, NL07C-25HT) | |
| ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance | Passed |
| Scooter Safety Performance Standards (S21F) | |
| ISO 7176-1, -3, -5, -7, -8, -15, -22 series | Passed |
| RESNA WC-1 series | Passed |
| ISO 7176-2, -4, -6, -9, -10 series | Passed |
| RESNA WC-2 series | Passed |
| ISO 7176-11, ISO 7176-13 | Passed |
| ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods | Passed |
| RESNA WC-2 Section 14:2009 - Power and control systems for electrically powered wheelchair and scooters - Requirements and test methods | Passed |
| ISO 7176-16:2012 Resistance to Ignition of Postural Support Devices Test | Passed |
| Biocompatibility (Dial Set & Handle Bar, materials: DIOSHY® TPU) | |
| ISO 10993-5:2009 in vitro Cytotoxicity test | Pass (Super Laboratory Co., Ltd.) |
| ISO 10993-10:2010 Maximization Sensitization test | Pass (Super Laboratory Co., Ltd.) |
| ISO 10993-10:2010 Skin Irritation test | Pass (Super Laboratory Co., Ltd.) |
| Biocompatibility (Seat Cushion, material: PU Foam) | |
| ISO 10993-5:2009 in vitro Cytotoxicity test | Pass (SGS Taiwan Ltd. Ultra Trace & Industrial Safety Hygiene) |
| ISO 10993-10:2010 Maximization Sensitization test | Pass (SGS Mechanical & Hardgoods Lab) |
| ISO 10993-10:2010 Skin Irritation test | Pass (SGS Mechanical & Hardgoods Lab) |
| Biocompatibility (Seat Leather, Seat Belt, material: Vinyl Fabric) | |
| ISO 10993-5:2009 in vitro Cytotoxicity test | Pass (SGS Mechanical & Hardgoods Lab) |
| ISO 10993-10:2010 Maximization Sensitization test | Pass (SGS Mechanical & Hardgoods Lab) |
| ISO 10993-10:2010 Skin Irritation test | Pass (SGS Mechanical & Hardgoods Lab) |
| Static Stability (Tilt over tests) with max load (253 lbs.) | 3 degrees (lateral, posterior, anterior) |
2. Sample size used for the test set and the data provenance:
This document describes the testing of a physical medical device (a scooter), not an AI/ML algorithm. The "test set" here refers to the device itself being tested against engineering standards. The data provenance is from Taiwan, where the manufacturer (Heartway Medical Products Co., Ltd.) is located and where testing laboratories (e.g., Super Laboratory Co., Ltd., SGS Taiwan Ltd.) are likely based. The testing appears to be prospective as it's part of a premarket notification for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the type of device and testing described. The "ground truth" for a physical device like a scooter is established by internationally recognized engineering and safety standards (e.g., ISO, RESNA, ANSI/AAMI), not by human experts creating a labeled dataset like for an AI algorithm. Compliance is determined by objective measurements and standardized test procedures in accredited laboratories.
4. Adjudication method for the test set:
Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving discrepancies in human expert labeling for AI/ML development. For a physical device, testing involves standardized procedures and measurements.
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 not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML medical device.
7. The type of ground truth used:
The ground truth used for this physical device is compliance with established engineering and safety standards (e.g., ISO 7176 series, RESNA WC-2 series, ANSI/AAMI ES60601-1, ISO 10993 series for biocompatibility). Test results (e.g., "Passed") confirm the device meets these pre-defined, objective criteria.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable.
§ 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).