(68 days)
The intended use of the TACAMO Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The DALTON INSTRUMENT CORPORATION Model TACAMO is a manually operated, self propelled, manual, mechanical wheelchair. The primary design function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or long term care facilities. The product has standard manual wheelchair features. It consists of the frame, 24" rear wheels with hand rims for propelling the chair, and 8'' front casters for steering and turning. The wheelchair frame is constructed from both 1.25" and 1" outside diameter(OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. TACAMO also comes with wheelchair cushion and seating system. TACAMO also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some situations. The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever disengage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 30 degrees and 30 degrees of reclining angle.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| RESNA ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (including Scooters)" | The DALTON INSTRUMENT CORPORATION wheelchair TACAMO meets the applicable performance requirements specified in this standard. |
| DIS ISO 7176 (1992) Part 8: "Requirements and Test Methods for Static, Impact and Fatigue Strengths" | The DALTON INSTRUMENT CORPORATION wheelchair TACAMO meets the applicable performance requirements specified in this standard. |
2. Sample Size and Data Provenance:
The document does not specify a separate "test set" in the context of typical AI algorithm evaluation with a specific sample size, country of origin, or retrospective/prospective nature. Instead, the performance is demonstrated through adherence to established wheelchair international standards. This implies that the device was physically tested against the specified parameters of these standards. The data provenance would be the results of these physical tests, likely conducted at the manufacturer's facility or a certified testing lab.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable in the context of this type of device submission. Ground truth is established by the specifications and methodologies within the RESNA and ISO standards, not by expert consensus on particular data points. The "experts" would be the engineers and technicians who conducted the tests according to the standard protocols and interpreted the results against the standard's criteria.
4. Adjudication Method:
Not applicable. Device performance is determined by meeting objective industrial standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a physical medical device (manual wheelchair), not a diagnostic or AI-driven imaging device that would typically undergo MRMC studies.
6. Standalone Performance Study:
Yes, a standalone performance was done in the sense that the device was tested independently against the published international standards (RESNA ANSI/RESNA WC/Vol.1-1998 and DIS ISO 7176 (1992) Part 8). The stated compliance confirms its standalone performance against these benchmarks.
7. Type of Ground Truth Used:
The ground truth used is based on established, internationally recognized engineering and safety standards for wheelchairs. This includes quantitative measurements and test procedures for static, impact, and fatigue strengths, as well as general requirements for wheelchairs.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data. The design and manufacturing processes are informed by engineering principles and safety standards, rather than machine learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing processes are guided by recognized engineering practices and the requirements outlined in the RESNA and ISO standards.
§ 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).