(22 days)
The K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to:
- Comfort for increased sitting tolerance .
- Positioning to increase upper body stability .
- Pressure relief or reduction to shift the end user's body weight from the buttocks to the back .
Track Corporation makes no claims as to the therapeutic effectiveness of this device. our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
The Track Corporation K-Tech Power Tilt Seating System is an aftermarket, center of gravity design power tilt in space system for power wheelchairs. The K-Tech 2 is designed to be able to be installed in the field by qualified dealerships on to most commercially available power wheelchairs appropriate for power seating accommodation. The standard system configuration consists of two sets of steel tracks, an inner and outer set. This track configuration has been used in the automotive industry very successfully for many years, under more rigorous conditions than wheelchairs experience. The outer tracks of the K-Tech 2 are attached to the power wheelchair via mounting hardware that is designed to interface to each specific power chair. The outside tracks also provide the quide tracks for the inside tracks to tilt and slide forward, creating the center of gravity movement. The aluminum seat pan and the inside tracks support the back support uprights. The K-Tech 2 utilizes an automotive seat adjuster motor manufactured by Fasco and has a maximum load capacity of 500 pounds. The Fasco motor has an integrated overload protection to protect the motor from current overload and over use by the end user. The tilt drive assembly found integrated into the back end of the inner tracks follows a steel leadscrew attached inside of each of the outer tracks. This creates a dual screw drive which is much more efficient and does not put the users weight directly on the tilt adjuster, unlike on the actuators that are found on the predicate device(s). This is a significant improvement in durability and safety in power wheelchair seating. If the motor should ever fail, the tilt drive assembly will not change its relationship to the leadscrew. The end user is protected from the system either falling backward or free falling back down to the neutral seated position due to motor failure. An additional benefit of using the tilt drive assembly and ball screw is the tilting of the system is achieved by the movement of the screw quide on the ball screw. This allows the device to tilt and slide forward without exerting great stress and opposing forces on the frame, which exist on the predicate devices and all other available tilt power seating systems. Over time, these opposing forces cause undue strain on the frame, leading to possible serious failure. The K-Tech 2 is activated with a standard low amp toggle switch. It can also be activated by running the system through commercially available optional specialty controls for the end user that does not have the ability to activate a toqgle switch. As the toqgle switch is activated, the K-Tech 2 will beqin to tilt and simultaneously move forward to center the end user's weight over the power chair base, maintaining stability of the base and end user while tilted. The K-Tech has a standard infinitely adjustable tilt range of zero to 55 degrees and custom tilt ranges are available. There is a micro-switch attached to the frame, which is activated once the end user tilts past 20 degrees, locking out the driving capabilities of the power chair for safety.
Here's an analysis of the provided text regarding the K-Tech 2 Power Tilt Seating System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance |
|---|---|
| Durability / Cycle Life Performance | Completed 18,000 tilt cycles satisfactorily without failure. |
| Safety - Overload Protection | Fasco motor has integrated overload protection to protect from current overload and over use. |
| Safety - Motor Failure (Prevention of back-drive) | If motor fails, tilt drive assembly will not change relationship to leadscrew (no back-drive); user protected from falling backward or free-falling. |
| Stability (while tilted) | System tilts and simultaneously moves forward to center user's weight over power chair base, maintaining stability. |
| International Standards Compliance | In its standard configuration, meets applicable requirements specified in ISO 7176. |
| Prevention of Driving while Tilted | Micro-switch activated past 20 degrees tilt, locking out driving capabilities for safety. |
| Load Capacity | Maximum load capacity of 500 pounds. |
| Infinitely Adjustable Tilt Range | Standard infinitely adjustable tilt range of zero to 55 degrees (custom ranges available). |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary document only mentions one specific quantitative test: the Cycle/Durability Test.
- Test Set Sample Size: Implicitly, the "K-Tech 2" device (singular) was subjected to the test. No number of units is explicitly stated for the test.
- Data Provenance: The document does not specify the country of origin for the test data. It broadly states "Results are found in appendix D," which is not provided in the excerpt. It is a prospective test, as it describes the device being actively tested to meet criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable or not specified. For a mechanical durability test, ground truth is typically based on quantifiable performance metrics (e.g., number of cycles without failure) rather than expert interpretation.
- Qualifications of Experts: Not applicable or not specified for this type of performance data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "satisfactorily without failure" outcome for the durability test is a direct measurement against a predefined criterion, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or mentioned. This device is a mechanical seating system, not an imaging or diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Standalone Study: Yes, the performance data presented (e.g., 18,000 tilt cycles, overload protection, back-drive prevention) represents the standalone performance of the device itself without human interaction during the testing phase, other than operating the test rig. This is a common form of device testing for mechanical and electro-mechanical systems.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Performance Specification/Engineering Standard: For the cycle/durability test, the ground truth is the successful completion of 18,000 cycles without failure, as defined by an internal engineering standard or a recognized international standard (like ISO 7176 requirements).
- Functional Specification: For features like overload protection, anti-back-drive, and driving lockout, the ground truth is the device correctly performing these functions as designed and specified.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, prototyping, and iterative testing/refinement.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As it's not an AI/ML system, the concept of establishing ground truth for a training set doesn't apply. The design and development process for a mechanical device relies on engineering principles, material science, and iterative testing against performance requirements.
§ 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).