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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

KP-10.3S is meant to provide mobility to persons who are not able to walk, stand or use a manual wheelchair, but who are very well able to control and use the interface of an electrically powered wheelchair is not suitable for persons who do not have the cognitive skills to drive an electrically powered wheelchair by themselves. Also, it is not suitable for visually impaired persons. This wheelchair is suitable for users up to 264 lbs. (120 kg) in weight.

KP-10.3S is classified as a class B mobility product for indoor and outdoor use. It also has an extremely durable steel frame with tough components and does not suffer in dramatic extremes of temperature (neither the operator nor the attendant need touch metal parts in normal use). The compact size of this wheelchair, the excellent speed range and battery capacity makes the wheelchair suitable for both indoor and outdoor use. The KP-10.3S can be disassembled into four parts easily and can also be quickly assembled, which is convenient for storage and transportation.

The powered wheelchair KP-10.3S is an affordable rear wheel drive power chair. It features the patented S-Ergo Seating System and promotes a comfortable seating and a good posture. The device is powered by two 12 volt / 22 Ah lead acid batteries with 8.75 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (100 -240 V, 50-60 Hz), when the device is not in use.

Compact design makes it ideal for confined spaces mobility and short distance journey. The 36 inches turning radius for easy entry and exit of small elevator, making indoor activity effortless. It is tool-free disassembly, and can be easily placed in a car trunk, making travel possible and simple.

There are flip-back and height adjustable armrest, swing-away detachable footrest for KP-10.3S, and tool-free inclination angle adjustable backrest (15° - 27°) for KP-10.3S. The optional quick release steering controller enables maneuvering switches from the user to the attendants in seconds. The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of KP-10.3S is 264 lbs and its maximum speed is 3.75 mph.

This document describes the Karma Powered Wheelchair, KP-10.3S, and its substantial equivalence to a predicate device, Comfort Powered Wheelchair, Traveler LY-EB103 (K030356). The document focuses on demonstrating that the new device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KP-10.3S are implied by its compliance with various ISO 7176 standards, which are internationally recognized test methods for wheelchairs. The "device performance" in this context refers to the successful completion of these tests, demonstrating that the KP-10.3S meets the safety and effectiveness requirements outlined by these standards.

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

The document does not specify the exact sample sizes (number of devices) used for the non-clinical performance tests for the KP-10.3S. The tests appear to be conducted on the Karma Powered Wheelchair, KP-10.3S itself. The data provenance is implied to be from the manufacturer (Karma Medical Products Co., Ltd. in Taiwan), and the studies are understood to be prospective testing conducted specifically for this submission, as they refer to "the data generated from each test in the ISO 7176 series test reports of the subject device."

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

For non-clinical performance tests such as those specified by ISO and RESNA standards, "ground truth" is established by the standardized test methods themselves and the specified criteria for passing those tests. There isn't typically a panel of human experts in the medical sense to establish ground truth for mechanical and electrical performance. The "experts" are the engineers and technicians who perform the tests according to the standards and interpret the results against the defined acceptance thresholds. Their qualifications would involve expertise in test procedures, equipment operation, and understanding of the relevant ISO/RESNA standards. The document does not explicitly state the number or specific qualifications of these individuals but implies their involvement through the successful completion of the tests.

4. Adjudication Method for the Test Set

Not applicable. For non-clinical performance tests, adjudication (like 2+1 or 3+1 consensus among experts) is not typically used. The results are objectively measured against predefined technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Karma Powered Wheelchair is a physical medical device for mobility, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is irrelevant to this device.

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

Not applicable. The Karma Powered Wheelchair is a physical device, not an algorithm. Its performance is evaluated through physical and electrical testing according to international standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical performance tests is based on objective measurements and predefined acceptance criteria as established by recognized international and national standards (ISO 7176 series and RESNA WC-2). For biocompatibility, the ground truth is established by comparison to previously cleared predicate device materials with established biocompatibility, assuming identical formulation, processing, sterilization, and geometry for patient-contacting parts.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm, and thus does not involve 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, there is no ground truth to be established for it.

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