(172 days)
The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle.
The TX Wheelchair Chassis is designed and manufactured by JCM Seating Solutions for the mobilization of both our own postural seating systems and those manufactured by other specialist seating providers, and is indicated for occupants ages 2 to adult, and intended primarily for general indoor and outdoor (smooth surfaces) use.
The chassis consist of a fabricated steel framework with two rear wheels and two front castors where both front and rear wheel sizes can be selected at point of order from a pre-determined range. The TX Wheelchair Chassis also has a "tilt in space" feature that allows for the user's position in space to be changed between -30°/+5°, which may lead to improvements in postural stability and comfort, contributing to enhanced functional activity. A push handle is provided to enable an attendant to propel the chassis and the seated occupant and under certain circumstances the product could be setup to enable the occupant to self-propel through the rear wheels themselves. The chassis and seating system combination can also be used for transporting the occupant in a suitable motor vehicle and has tie-down points to facilitate this.
The TX Wheelchair Chassis is designed for the mobilization of individuals aged 2 to adult for general indoor and outdoor use on smooth surfaces, and can also be used for transportation in a motor vehicle.
Here’s an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Test Performed | Reported Device Performance |
|---|---|---|
| Static Stability | ANSI/RESNA WC-1:2009 WC Section 1 | Passed |
| Effectiveness of Brakes | ANSI/RESNA WC-1:2009 WC Section 3 | Passed |
| Overall Dimensions, Mass, and Turning Space | ANSI/RESNA WC-1:2009 WC Section 5 | Passed |
| Measurement of Seating and Wheel Dimensions | ANSI/RESNA WC-1:2009 WC Section 7 | Passed |
| Static, Impact, and Fatigue Strengths | ANSI/RESNA WC-1:2009 WC Section 8; ISO 7176-8:1998 | Passed |
| Requirements for Information, Disclosure, Documentation, and Labeling | ANSI/RESNA WC-1:2009 WC Section 15 | Passed |
| Application of Risk Management to Medical Devices | ISO 14971:2007 | No specific performance reported, but adherence to standard implies risk management process was followed. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the number of individual devices tested for each standard. However, it indicates that "its device" (singular) was submitted for testing, suggesting at least one representative sample was subjected to the various tests. The testing was performed in accordance with national and international standards, implying that the data provenance is from a controlled testing environment, likely performed by a third-party testing facility. The country of origin of the device manufacturer is the United Kingdom. This was a non-clinical, retrospective study in the sense that the testing was performed on the completed device to demonstrate its compliance with established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for the performance criteria of a mechanical device like a wheelchair chassis is established by the defined parameters and methodologies within the recognized consensus standards (ANSI/RESNA WC-1 and ISO 7176-8). The testing engineers/technicians performing the tests are qualified to execute these standardized procedures, but they don't establish "ground truth" in the same way clinical experts do for diagnostic tests.
4. Adjudication Method for the Test Set
This information is not applicable. The device's performance against the acceptance criteria is objectively measured based on the standardized test protocols, not through expert adjudication in the context of clinical agreement or subjective assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved. The TX Wheelchair Chassis is a mechanical device, and its safety and effectiveness are assessed through engineering and performance testing against established standards, not through comparative studies with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a "standalone" study in the context of an algorithm's performance was not done. This device is a mechanical product, not an AI or software algorithm. Its performance is inherent to its physical design and construction under various load and usage conditions.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance is defined by the objective pass/fail criteria and tolerance limits established within the cited consensus standards:
- ANSI/RESNA WC-1:2009, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters)
- ISO 7176-8:1998, Wheelchairs -- Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
- ISO 14971:2007, Medical Devices -- Application of Risk Management to Medical Devices
These standards specify the conditions, procedures, and acceptable outcomes for tests related to static stability, brake effectiveness, dimensions, strength, and fatigue.
8. The Sample Size for the Training Set
This information is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set. The design and manufacturing process would involve engineering specifications and quality controls, but not "ground truth" in the context of data for model training.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).