(114 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.
This document is an FDA 510(k) Premarket Notification for a Power Wheelchair (Model N6102). It aims to demonstrate substantial equivalence to a predicate device (K230964). Since this is a submission for a physical medical device (a power wheelchair) and not a software/AI-driven diagnostic or therapeutic device, the concepts of acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and separate training/test sets are not applicable in the context of typical AI/ML device evaluations.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a power wheelchair primarily revolve around compliance with recognized performance and safety standards (ISO 7176 series, IEC 60601-1-2, ISO 10993 series) and demonstrating that any differences from a predicate device do not raise new safety or effectiveness concerns.
Here's how to interpret the provided information in the context of device acceptance, organized to address your prompt's structure where applicable, but noting the non-applicability of certain AI/ML-specific terms:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of the proposed device against a predicate device, largely referencing compliance with international standards. The "acceptance criteria" are implied by these standards and the "reported device performance" is the statement of compliance or comparison to the predicate.
| Acceptance Criteria (Implied by Standard/Predicate) | Reported Device Performance (Subject Device) | Discussion/Remark (from document) |
|---|---|---|
| General Characteristics | ||
| Classification | Class II | Same |
| Product Code | ITI | Same |
| Indications for Use | Motor driven, indoor/outdoor transportation for disabled/elderly limited to seated position. | S.E. (Substantially Equivalent) |
| Intended User | Disabled or elderly person limited to a seated position. | S.E. |
| Use Condition | Indoor and outdoor use | S.E. |
| Driving System | Direct drive on the rear wheels | S.E. |
| Brake System | Automatic electromagnetic brake system | S.E. |
| Armrest Material | T700 (Predicate) | Carbon fibers |
| Main Frame Material | Carbon fiber material | Carbon fiber material |
| Back Cushion Material | Polyester fabric (Predicate) | Polyester fiber |
| Seat Cushion Material | Polyester fiber | Polyester fiber |
| Number of Wheels | 4 (two front, two rear) | 4 (two front, two rear) |
| Function of Wheels | Front: driven for rotation, acceleration, retrograde; Rear: driving for speed/direction. | Same |
| Movement Control | By Joystick control | By Joystick control |
| Battery (Type & Specs) | li-ion battery pack, 24V, 10Ah | li-ion battery pack, 24V, 10Ah |
| Battery Charger (Type & Specs) | Off-board, Input: 100-240V, 50/60Hz, 1.5A; Output: 24Vdc, 2A | Same |
| Motor (Type & Specs) | Brushless DC motor; 24VDC; 150W; 2pcs | Brushless Eco-Drive, 24V, 150W, 2pcs |
| Electronic Controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller |
| Turning Radius | 900mm | 900mm |
| Performance Characteristics | ||
| Braking Distance | ≤1.5 m (Predicate) | 780mm |
| Maximum Safe Operational Incline Degree | 9° | 9° |
| Overall Dimension (LWH) | 900580860mm (Predicate) | 950610960mm |
| Front Wheel Size/Type | 7" x 1.75"/PU Solid tire (Predicate) | 7" x 1.78"/PU Solid tire (180mm x 45mm) |
| Rear Wheel Size/Type | 8.5" x 1.8"/PU Solid tire (Predicate) | 9" x 2"/PU Solid tire (230mm x 50mm) |
| Max Speed Forward | Up to 6 km/h (1.6 m/s), adjustable (Predicate) | 1.54 m/s (5.5km/h) |
| Max Loading Weight | 110kg (≈250lbs) (Predicate) | 136kg (≈300lbs) |
| Maximum Distance of Travel on Fully Charged Battery | 10 km (Predicate) | 16.1km |
| Maximum Obstacle Climbing | 40 mm (Predicate) | 25mm |
| Safety & Compliance (Implied by Standards) | ||
| Biocompatibility | ISO10993-5, ISO10993-10, ISO10993-23 requirements | Compliance with ISO10993-5, ISO10993-10, ISO10993-23 |
| EMC Performance | ISO7176-21 and IEC 60601-1-2 | Compliant with ISO7176-21 and IEC 60601-1-2 |
| General Performance | ISO7176 series | Compliant with ISO7176 series |
| Label and Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory |
| Specific ISO Standard Compliance | ||
| ISO 7176-1 (Static Stability) | Meets design specification | Meets design specification |
| ISO 7176-2 (Dynamic Stability) | Meets design specification | Meets design specification |
| ISO 7176-3 (Brakes Effectiveness) | Meets design specification | Meets design specification |
| ISO 7176-4 (Theoretical Distance Range) | Meets design specification | Meets design specification |
| ISO 7176-5 (Dimensions, Mass) | Determined/Meets | Determined/Meets |
| ISO 7176-6 (Dimensions, Mass) | Determined/Meets | Determined/Meets |
| ISO 7176-7 (Seating & Wheel Dimensions) | Determined/Meets | Determined/Meets |
| ISO 7176-8 (Requirements) | All test results meet requirements | All test results meet requirements |
| ISO 7176-9 (Dynamic Tests) | Continue to function after tests | Continue to function after tests |
| ISO 7176-10 (Obstacle-climbing ability) | Determined/Meets | Determined/Meets |
| ISO 7176-11 (Test Dummies) | Meet requirements | Meet requirements |
| ISO 7176-13 (Coefficient of Friction) | Determined for use in other 7176 series tests | Determined for use in other 7176 series tests |
| ISO 7176-14 (Requirements) | All test results meet requirements | All test results meet requirements |
| ISO 7176-15 (Information Disclosure, Labeling) | Meets requirements | Meets requirements |
| ISO 16840-10:2021 (Fire Resistance) | Performance meets requirements | Performance meets requirements |
| ISO 7176-25 (Batteries and Charger) | Performance meets requirements | Performance meets requirements |
2. Sample sizes used for the test set and the data provenance
This information is not provided as it's not relevant for a direct testing of a physical device against standards (e.g., you test a specific number of manufactured units or prototypes for compliance, not a "data set"). The provenance isn't applicable in the same way either; the tests are performed on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of device performance is established by the specified ISO standards and validated test methods (e.g., a test rig for stability or braking) and direct measurements. It doesn't rely on expert consensus in the same way an AI diagnostic image reading might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, the "truth" is determined by objective measurements against engineering standards, not through a consensus of human interpretative results.
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 study is for a physical power wheelchair, not an AI software. There are no "human readers" or "AI assistance" in its intended function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not contain an algorithm in this context. Its "performance" is mechanical and electrical, not computational.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from:
- International Standards: Primarily the ISO 7176 series, IEC 60601-1-2, and ISO 10993 series, which define objective test methods and acceptable performance limits for wheelchairs.
- Engineering Specifications: The design specifications for the device itself (e.g., max speed, loading weight, dimensions).
- Physical Testing: Direct physical measurements and tests on the device (e.g., dynamic stability tests, braking distance tests, obstacle climbing tests).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
In summary, the "study" proving the device meets the "acceptance criteria" is a series of engineering tests and analyses demonstrating compliance with relevant international performance and safety standards for power wheelchairs, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. The differences noted (e.g., slightly different dimensions, braking distance, max loading weight, travel distance, obstacle climbing) are all deemed not to raise new safety or effectiveness concerns, with testing conducted to confirm compliance with the applicable standards even with these differences (e.g., "All safety and performance have been validated with the maximum rated weight dummy").
§ 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).