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510(k) Data Aggregation
(128 days)
WHILL Model C2 (K213383)
The intended use of the Electric Wheelchair (Model: BBR-LY-01-01) is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The Electric Wheelchair (Model: BBR-LY-01-01) is an indoor/outdoor, battery-operated, 2-wheel drive (rear-wheel drive) powered wheelchair. lt consists of four modules: seat system, control system, braking system, and drive system. The user sits in the wheelchair seat and uses the control system. The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement. The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle. The wheelchair is powered by a 24V DC,20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors. The Electric Wheelchair (Model: BBR-LY-01-01) contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device. The wheelchair can be folded automatically.
This document describes the FDA's 510(k) clearance for the Shanghai BangBang Robotics Co., Ltd. Electric Wheelchair (Model: BBR-LY-01-01). As such, it focuses on demonstrating "substantial equivalence" to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner an AI/ML algorithm submission would.
Therefore, many of the requested points are not applicable to this type of regulatory submission for a physical medical device. However, I can extract the relevant information regarding performance and testing.
1. A table of acceptance criteria and the reported device performance
For a physical device like an electric wheelchair, "acceptance criteria" are generally compliance with recognized consensus standards. The performance is reported as meeting these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Static Stability (ISO 7176-1:2014) | Complies |
| Dynamic Stability (ISO 7176-2:2017) | Complies (specifically tested 6° dynamic stability vs. predicate's 10°) |
| Effectiveness of Brakes (ISO 7176-3:2017) | Complies (minimum braking distance 120cm vs. predicate's 1500mm) |
| Energy Consumption & Theoretical Distance Range (ISO 7176-4:2008) | Complies (driving range 20.6km vs. predicate's 17.7km) |
| Overall Dimensions, Mass, and Maneuvering Space (ISO 7176-5:2008) | Complies (dimensions differ from predicate but meet standard) |
| Maximum Speed, Acceleration, and Deceleration (ISO 7176-6:2018) | Complies (max forward speed 6km/h vs. predicate's 8km/h) |
| Measurement of Seating and Wheel Dimensions (ISO 7176-7:1998) | Complies (seating/wheel dimensions differ from predicate but meet standard) |
| Static, Impact, and Fatigue Strengths (ISO 7176-8:2014) | Complies |
| Climatic Tests (ISO 7176-9:2009) | Complies (operating/storage conditions differ from predicate but meet standard) |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | Complies |
| Test dummies (ISO 7176-11:2012) | Complies |
| Determination of coefficient of friction of test surfaces (ISO 7176-13:1989) | Complies |
| Power and Control Systems (ISO 7176-14:2008) | Complies |
| Information Disclosure, Documentation and Labeling (ISO 7176-15:1996) | Complies |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16:2012) | Complies |
| Set-up Procedures (ISO 7176-22:2014) | Complies |
| Batteries and Chargers (ISO 7176-25:2013) | Complies |
| Electromagnetic Compatibility (ISO 7176-21:2009 & IEC 60601-1-2:2014) | Complies |
| FCC RF Compliance (FCC CFR TITLE 47 PART 15 SUBPART C, PART 2.1093) | Complies (wireless RF frequency/output power differ from predicate but meet standard) |
| Wireless Coexistence (ANSI C63.27-2017) | Complies |
| Biocompatibility (ISO 10993-5:2009 & ISO 10993-10:2010) | Complies |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically not included in a 510(k) summary for a non-software medical device. Testing against ISO standards usually involves a representative number of physical units, not a "test set" of data in the AI/ML sense. The testing would have been done by the manufacturer (Shanghai BangBang Robotics Co., Ltd. in China) and verified by a recognized testing body.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. For a physical device, "ground truth" is established by the direct physical measurement and performance testing against the specifications outlined in the international consensus standards (e.g., measuring stability, braking distance, dimensions). This does not involve expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or similar diagnostic tasks, typically for AI/ML algorithms. This is not relevant for the performance testing of an electric wheelchair.
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. MRMC studies are specific to evaluating the impact of AI on human readers (e.g., radiologists interpreting images). This device is a physical product (electric wheelchair) and does not involve "human readers" or "AI assistance" in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is an electric wheelchair, not an algorithm. While it has a control system and Bluetooth connectivity, its primary function is mechanical mobility, and it is always operated with a human in the loop (the user or a remote controller).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with international consensus standards (ISO 7176 series and others) through objective performance testing and measurement. For example, the braking distance being 120cm is a factual measurement, not an expert opinion or pathology finding.
8. The sample size for the training set
Not Applicable. This is not an AI/ML algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. No training set exists for this type of device submission.
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