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The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.

The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners.

The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels.

Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.

The provided 510(k) summary for the CHOICE Powered Wheelchair details acceptance criteria and the results of non-clinical studies. No clinical trials were submitted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05 and 10, as well as Electromagnetic Compatibility (EMC) requirements.

• Downhill (Wheel locks locked): No slide, Tip at 17.5° (with 1.6" block)
• Uphill (Wheel locks locked): No slide, Tip at 18° (with 0" block)
• Uphill (Wheel locks unlocked): Tip at 43° (with 1.6" block)
• Sideways (Wheel locks locked): Tip at 49° (with 3.9" block), No slide, Tip at 22° (with 0" block), Tip at 35° (with 1.6" block)
  Seat fully up:
• Downhill (Wheel locks locked): No slide, Tip at 12° (with 1.6" block)
• Uphill (Wheel locks locked): No slide, Tip at 18° (with 0" block)
• Uphill (Wheel locks unlocked): Tip at 43° (with 1.6" block)
• Sideways (Wheel locks locked): Tip at 49° (with 3.9" block), No slide, Tip at 19° (with 0" block), Tip at 26° (with 1.6" block) |
  | WC 02: Dynamic Stability (e.g., stability during ramps, braking, turning) | Seat fully down:
• Up ramp with max acceleration: 22° to lift (front-wheel-drive unit)
• Braking down 5 deg.: Stable (equipped with anti-tip devices)
• Turning: Stable (equipped with anti-tip devices)
  Seat fully up:
• Up ramp with max acceleration: 19° to lift (front-wheel-drive unit)
• Braking down 5 deg.: Stable (equipped with anti-tip devices)
• Turning: Stable (equipped with anti-tip devices) |
  | WC 03: Stopping Distances from Maximum Speed | Max Speed (mph): Forward 5.2, Reverse 1.3
• Forward, Horizontal Plane: Max 3.3 ft, Auto 3.8 ft
• Backward, Horizontal Plane: Max 2.3 ft, Auto 2.8 ft
• Forward, down 5° Incline: Max 3.3 ft, Auto 3.8 ft |
  | WC 05: Overall Dimensions (turning space) | Turning radius: 24 inches (610 mm)
  Turnaround width between limiting walls: 44 inches (1118 mm) |
  | WC 10: Obstacle Climbing | - Forward no run-up: 2.25 inches (57.15 mm)
• Backward no run-up: 2.25 inches (57 mm)
• Forward 20 inch run-up: 3 inches (76 mm)
• Backward 20 inch run-up: 2.25 inches (57 mm) |
  | Electromagnetic Compatibility (EMC) | Fully compliant with EMC specification requirements with a test level of 40 V/m. Meets or exceeds all requirements of the test specification. |

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing performed on "The CHOICE" wheelchair itself. This implies that the 'sample size' for the test set is one device (the CHOICE powered wheelchair).

The data provenance is from non-clinical laboratory testing performed in accordance with established standards (ANSI/RESNA Standard WC/14 and EMC proposals). The testing was conducted for the purpose of a premarket notification, suggesting a prospective assessment of the device against these standards. The location of the testing is not explicitly stated beyond referencing American Medical Technologies, Inc. (Canton, Georgia) and the controller's manufacturer (Penny & Giles, Dorset, UK), but the standards are international (ANSI/RESNA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This study involved non-clinical physical and electrical testing of a medical device against pre-defined engineering standards. There was no 'ground truth' established by human experts in the context of diagnostic or interpretive tasks. The "ground truth" here is the pass/fail criteria of the engineering standards themselves.

4. Adjudication Method for the Test Set

Not applicable. As the study involved physical testing against engineering standards, an adjudication method for human interpretation or consensus was not required. The results were numerical measurements or observations of stability (e.g., tip angle, stopping distance, obstacle height) directly compared to the standard's requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC comparative effectiveness study was not performed. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields. This submission is for a physical medical device (powered wheelchair) and focuses on its engineering performance against safety and functionality standards.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in essence. The entire submission can be considered a "standalone" performance assessment, but not in the context of an "algorithm only" as typically applied to AI. The tests evaluated the intrinsic performance of the CHOICE powered wheelchair itself (the "device only") against objective engineering standards, without a human operator's performance being assessed or augmented. There is no AI algorithm being evaluated; rather, the performance of the physical wheelchair is being characterized.

7. The Type of Ground Truth Used

The ground truth used is the defined pass/fail criteria and measurement thresholds specified within the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991 (parts 00, 01, 02, 03, 05 and 10), and the "Proposal, Addition to ANSI/RESNA WC/14 - Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters', Ver. 1.5; 1/11/94". These standards establish the acceptable performance limits for various safety and functional aspects of powered wheelchairs.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in this context. The CHOICE powered wheelchair is a physical device being tested against pre-existing engineering standards. It does not involve machine learning or AI models that require data for training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for a training set.

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