(244 days)
The intended use of the Solax Powered Wheelchair is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair.
The Solax Powered Wheelchair (Model S7102) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The Solax Powered Wheelchair (Model S7102) is with 100 kg (220 lbs) weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two Li-ion batteries with an off-board battery charger. It is powered by rechargable batteries with 27.65 km which maximum speed upto 6.2 km/hr. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.
lt consists of four parts which are chair part, control part, folding part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake, a remote for folding the device and a Lithium battery with an off-board charger.
The provided document is a 510(k) summary for the Solax Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device based on performance standards, rather than presenting a study of diagnostic or clinical effectiveness with specific acceptance criteria in the way a medical AI/ML device would.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. The document describes engineering and manufacturing specifications and adherence to international standards for wheelchairs.
However, I can extract the relevant information from the document regarding its "performance summary" which serves as the fulfillment of its acceptance criteria in the context of a powered wheelchair.
Here's the closest interpretation of your request based on the provided document:
Acceptance Criteria and Device Performance for Solax Powered Wheelchair (K182576)
The "acceptance criteria" for the Solax Powered Wheelchair are considered met by demonstrating compliance with various parts of the ISO 7176 standard series (Wheelchairs) and IEC standards for medical devices and software. The "study" proving this is the successful completion of these tests as reported by the manufacturer.
1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance
| Acceptance Criteria (ISO/IEC Standard) | Reported Device Performance (Compliance Statement) |
|---|---|
| ISO 7176-1: 2014 (Static stability) | Conducted with Solax Powered Wheelchair |
| ISO 7176-2:2001 (Dynamic stability) | Conducted with Solax Powered Wheelchair |
| ISO 7176-3: 2012 (Effectiveness of brakes) | Conducted with Solax Powered Wheelchair |
| ISO 7176-4: 2008 (Energy consumption/theoretical distance range) | 27.65 km range (complies with ISO 7176-4 Requirement as per Note 2) |
| ISO 7176-5: 2008 (Overall dimensions, mass and manoeuvring space) | Conducted with Solax Powered Wheelchair (Size and Base Weight comply with ISO 7176-5 Requirement as per Note 1) |
| ISO 7176-6: 2001 (Maximum speed, acceleration and deceleration) | Max speed: 6.2 km/h (complies with ISO 7176-6 Requirement as per Note 2) |
| ISO 7176-7: 1998 (Measurement of seating and wheel dimensions) | Conducted with Solax Powered Wheelchair (Tires comply with ISO 7176-7 Requirement as per Note 1) |
| ISO 7176-8:2014 (Static, impact and fatigue strengths) | Conducted with Solax Powered Wheelchair |
| ISO 7176-9:2009 (Climatic tests) | Conducted with Solax Powered Wheelchair |
| ISO 7176-10:2008 (Obstacle-climbing ability) | 50mm obstacle climbing ability (conducted with Solax Powered Wheelchair) |
| ISO 7176-11: 2012 (Test dummies) | Conducted with Solax Powered Wheelchair |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Conducted with Solax Powered Wheelchair |
| ISO 7176-14:2008 (Power and control systems) | Conducted with Solax Powered Wheelchair (Drive System complies with ISO 7176-14 Requirement as per Note 2) |
| ISO 7176-15:1996 (Information disclosure, documentation and labeling) | Conducted with Solax Powered Wheelchair |
| ISO 7176-16: 2012 (Resistance to ignition of postural support devices) | Conducted with Solax Powered Wheelchair |
| ISO 7176-21: 2009 (Electromagnetic compatibility) | Conducted with Solax Powered Wheelchair |
| ISO 7176-22: 2014 (Set-Up Procedures) | Conducted with Solax Powered Wheelchair |
| IEC 62304: 2006 (Medical device software, Software life-cycle processes) | Conducted with Solax Powered Wheelchair |
| IEC 60601-1-6: 2010 (Usability) | Conducted with Solax Powered Wheelchair |
| IEC 62366: 2007 (Application of usability engineering) | Conducted with Solax Powered Wheelchair |
Note: For specific parameters like "Maximum speed forward," "Energy consumption," "Minimum braking distance," "Base weight," "Maximum capacity," and "Obstacle Climbing Ability," the document provides specific values for the subject device and states that these comply with the relevant ISO 7176 requirements, even if different from the predicate device. For "Battery" and "Battery Charger," it states they comply with "ISO 7176 Requirement" (general reference).
2. Sample size 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 explicitly stated as a number of devices. "Solax Powered Wheelchair" (singular) is referred to, implying at least one physical device was tested against these standards.
- Data Provenance: The tests were "conducted with Solax Powered Wheelchair," implying these are prospective tests performed on the manufactured device. The manufacturer is "Dongguan Prestige Sporting Goods Co., Ltd." in Guangdong province, China, suggesting the testing was likely conducted in China or by a certified body on behalf of the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This isn't an AI/ML clinical study that requires expert adjudication for ground truth. Compliance with engineering standards is typically verified through standardized testing protocols executed by engineers or technicians in certified labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 document pertains to a powered wheelchair, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" equivalent here is the set of established performance criteria defined by the ISO 7176 and IEC standards for powered wheelchairs. The device performance is measured against these objective engineering and safety standards.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).