(780 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Solax Electric Scooter (Models: S204311M, S204161, S204143) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr. The movement of the scooter is controlled by the steering handles and control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.
This FDA 510(k) summary (K190737) describes the substantial equivalence of the Solax Electric Scooter to a previously cleared predicate device, rather than providing details of a study akin to those conducted for AI/ML-based medical devices. Therefore, much of the requested information regarding acceptance criteria, human reader studies, and ground truth establishment for AI systems is not applicable or present in this document.
However, I can extract information related to the performance testing and comparison to the predicate device, framing it as acceptance criteria and proof of meeting them within the context of a non-AI medical device.
Device Name: Solax Electric Scooter (Models: S204311M, S204161, S204143)
Intended Use: A motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like this electric scooter, "acceptance criteria" are typically defined by performance standards (e.g., ISO standards) and by demonstrating equivalence to a predicate device. The "reported device performance" is the successful compliance with these standards and the demonstration that any differences from the predicate do not raise new safety or effectiveness concerns.
| Acceptance Criteria Category (Derived from Standards & Predicate Comparison) | Specific Criterion (Standard / Predicate Characteristic) | Reported Device Performance (Subject Device Characteristic) | Meets Criteria? |
|---|---|---|---|
| General Characteristics (Equivalence to Predicate) | Same Intended Use as Predicate (K172440) | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | Yes |
| Same Indications for Use as Predicate | It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. | Yes | |
| OTC Use as Predicate | OTC | Yes | |
| Similar Tires (6 inches front, 7 inches rear, solid) | 6 inches for front wheel (solid wheel), 7 inches for rear wheel (solid wheel) | Yes | |
| Same Speed (6 km/h / 3.7 mph) | 6 km/h (3.7mph) | Yes | |
| Same Range (15 km / 9.32 mile) | 15 km (9.32mile) | Yes | |
| Same Battery Weight (1.84 kg) | 1.84 kg | Yes | |
| Same Brake Type (Electromagnetic) | Electromagnetic | Yes | |
| Same Drive System (PG 45A / Rear wheel drive) | PG 45A / Rear wheel drive | Yes | |
| Same Battery (Lithium battery 24V/10AH) | Lithium battery 24V/10AH | Yes | |
| Same Motor (24V 120W) | 24V 120W | Yes | |
| Same Battery Charger (DC24V/2A) | DC24V/2A | Yes | |
| Same Frame Design/Construction (X type, aluminum alloy) | X type, aluminum alloy frame | Yes | |
| Specific Performance Parameters (Compared to Predicate) | Overall Dimensions: S302121: 930450865mm | S204311M: 980450940mm, S204161: 930450860mm, S204143: 980450880mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) |
| Safe Gradient / Max Gradient: 0-12° | S204311M: 0-13°, S204161, S204143: 0-15° (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Turning Circle: 1.55 m | S204311M: 1.55m, S204161, S204143: 1.35 m (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Base Weight: 24 kg | S204311M: 24kg, S204161, S204143: 24.7 kg (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Maximum Capacity: 125 kg Approx. | 125 kg Approx. (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes | |
| Ground Clearance: 36 mm | S204311M: 38mm, S204161, S204143: 58mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Obstacle Climbing Ability: 38 mm | S204311M: 40mm, S204161, S204143: 60mm (Note 1: Minor differences, no deleterious effect on safety/effectiveness) | Yes (with justification) | |
| Folding Mechanism: Manual folding and remote folding (Predicate) | Manual folding for S204311M, S204161, S204143 (Note 2: Difference will not affect basic safety/indications for use, not a necessary function) | Yes (with justification) | |
| Remote Control: None (Predicate) | Yes (New feature, Note 2: Difference will not affect basic safety/indications for use, not a necessary function) | Yes (with justification) | |
| Safety and Performance Standards Compliance (Demonstrated through Testing) | ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability | Conducted | Yes |
| ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes | Conducted | Yes | |
| ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Conducted | Yes | |
| ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space | Conducted | Yes | |
| ISO 7176-6: 2018, Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-7, First Edition 1998-05-15, Wheelchairs Part 7: Measurement of seating and wheel dimensions | Conducted | Yes | |
| ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths | Conducted | Yes | |
| ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs | Conducted | Yes | |
| ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Conducted | Yes | |
| ISO 7176-11, Second edition 2012-12-01, Wheelchairs Part 11: Test dummies | Conducted | Yes | |
| ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient of friction of test surfaces | Conducted | Yes | |
| ISO 7176-14:2008, Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Conducted | Yes | |
| ISO 7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling | Conducted | Yes | |
| ISO 7176-16, Second edition 2012-12-01, Wheelchairs Part 16: Resistance to ignition of postural support devices | Conducted | Yes | |
| ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Conducted | Yes | |
| IEC 62304: 2006 (First Edition), Medical device software, Software life-cycle processes. (Applicable if there's software) | Conducted | Yes | |
| IEC 60601-1-6 Medical electrical equipment- Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.1, 2013 | Conducted | Yes | |
| IEC 62366 Medical devices Application of usability engineering to medical devices Edition 1.0.2007 | Conducted | Yes | |
| Biocompatibility | All user directly contacting materials compliant with ISO10993-5:2009 (Tests for In Vitro cytotoxicity) and ISO10993-10:2009 (Tests for irritation and delayed-type hypersensitivity) | Materials and manufacturing used are identical to predicate device, which demonstrated conformity. Subject device materials confirmed compliant. | Yes |
The remaining numbered points are primarily for AI/ML device studies and are not directly applicable to a traditional device 510(k) submission like this one, which relies on performance testing and substantial equivalence to a predicate.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an AI/ML test set. The study involves testing physical units of the scooter according to various ISO standards. The specific number of units tested is not detailed in this summary but would be determined by the requirements of each standard.
- Data Provenance: Not applicable. The "data" are results from physical performance and biocompatibility testing of the device itself, rather than a dataset of patient information. The testing would have been conducted by the manufacturer or a certified testing lab, likely in China, given the manufacturer's location. The testing is prospective in the sense that it's performed on the manufactured product to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the AI/ML sense (e.g., expert annotation of medical images) is not relevant here. Compliance with ISO standards is determined by prescribed test methods and objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human reader study requiring adjudication. Test results are objectively measured against standard specifications.
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-assisted device or an imaging device requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not use an algorithm in that capacity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the various ISO performance and safety standards, and the direct comparison of its physical and functional characteristics to the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device 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).