(199 days)
The Tango Series Powered Wheelchairs are indicated to provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons. Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render lower-limbs too weak or unstable for normal use or activity.
The Tango Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The two models are identical, except the frame. The BP1 has a steel frame and the BP1A has an aluminum frame. The wheelchair has four wheels, an adjustable seat with armrests, and a joystick controller for an attendant and the ability to disengage the wheel motor gear so that an attendant may use the chair as a free-wheel device. The automatic braking systems are an integral part of the controller and when the controller is released. Both models can be disassembled for easy transportation and reassembly and use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tango Powered Wheelchair, Models BP1 & BP1A:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K031711) for the Tango Powered Wheelchair does not explicitly list specific numerical acceptance criteria or performance metrics in a table format. Instead, it relies on substantial equivalence to predicate devices and compliance with voluntary standards.
However, based on the text, we can infer the general areas of "performance" that the manufacturer claims the device meets, primarily through equivalence.
| Acceptance Criterion (Inferred from Substantial Equivalence and Standards) | Reported Device Performance | Comments |
|---|---|---|
| Safety | "similar in design, construction, safety, efficacy..." | The device is deemed safe based on its similarity to legally marketed predicate devices and compliance with voluntary standards. |
| Efficacy | "similar in design, construction, safety, efficacy..." | The device is considered effective for its intended use based on its similarity to predicate devices. |
| Technology/Design | "similar in design, construction... and technology" | Tubular frame, battery operation, two motors, automatic braking systems are similar to predicates. Minor variations exist but do not impact substantial equivalence. |
| Intended Use | "provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons." | Matches the intended use of predicate devices. Specific indications for use (paraplegia, muscular dystrophy, etc.) are also aligned. |
| Controller | "...similar in... controller..." | The joystick controller is similar to those used in predicate devices (specifically comparing to Explorer). |
| Braking Systems | "...similar in... braking systems..." | Automatic braking systems are similar to predicates. |
| Voltage Use | "...similar in... voltage use..." | Similar to predicate devices (24 volts DC from two 12-volt batteries). |
| EMC Testing | "The Tango as well as its comparative equivalent devices has passed EMC testing for Electromagnetic Immunity." | Confirmed compliance with Electromagnetic Compatibility standards. |
| Compliance with Voluntary Standards/Guidance | "Compliance with voluntary standards and guidance documents published by international agencies, as well as by the Food and Drug Administration." | General statement of compliance, implying the device meets the requirements outlined in these standards. "Tests listed in the Guidance Document for the Preparation of Premarket Notification for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states:
- "Comparative performance testing and clinical evaluations were not conducted nor submitted as part of this 510(k)."
This means:
- Sample Size for Test Set: Not applicable, as no comparative performance testing with a specific test set of users or data was conducted or submitted.
- Data Provenance: Not applicable, as no specific test data was generated for the Tango device to demonstrate performance against acceptance criteria directly. The substantial equivalence relies on the known performance and safety of the predicate devices and general compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Since no specific performance testing or clinical evaluation with a test set was conducted for the device against specific ground truth, there was no need for experts to establish ground truth for such a test set.
4. Adjudication Method for the Test Set
- Not applicable. As no performance testing with a test set was conducted that required expert review or adjudication.
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 device (powered wheelchair) is a purely mechanical/electrical device, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study related to human "readers" or AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a powered wheelchair and does not involve any algorithms or AI to be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable directly for the Tango device. The "ground truth" in this 510(k) submission is effectively the established safety and effectiveness of the predicate devices and the compliance with recognized industry standards and guidance documents. The claim is that because the Tango is substantially equivalent in design and function to these, it inherently meets the same underlying "ground truth" of safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for this device.
In summary, the K031711 submission for the Tango Powered Wheelchair relies on the concept of "substantial equivalence" to predicate devices and general compliance with recognized standards rather than conducting and presenting specific performance studies with acceptance criteria, test sets, or ground truth for the device itself. The FDA's clearance (DEC 18 2003) indicates that they accepted this approach for this Class II device.
§ 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).