(127 days)
The intended use of the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 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 (Robooter E40), Model name: BBR-E40-01 is an indoor/outdoor, battery-operated, 2-wheel drive (rear-wheel drive) powered wheelchair. It 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 panel positioned on the right or left armrest allows the user to turn the wheelchair on, control the speed, and direct the movement. The braking system employs an electromagnetic brake. When the controller rocker is released, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. The 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 (Robooter E40), Model name: BBR-E40-01 contains Bluetooth 4.1 BLE technology. The device can be 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, 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/expanded manually. The Left and right handrails (joystick) can be interchange.
The provided text is a 510(k) Summary for an Electric Wheelchair (Robooter E40), Model: BBR-E40-01. It describes how the device compares to a predicate device and the performance testing conducted to demonstrate substantial equivalence. However, it does not involve an AI algorithm with specific acceptance criteria related to accuracy, sensitivity, or specificity. Therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
For a medical device like an electric wheelchair, the "acceptance criteria" are compliance with various safety and performance standards, primarily ISO 7176 series, rather than metrics like accuracy or sensitivity for an AI system. The device aims to meet these standards to demonstrate substantial equivalence to a predicate device.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1:2014 (Static stability) | Complies |
| ISO 7176-2:2017 (Dynamic stability) | Complies |
| ISO 7176-3:2012 (Effectiveness of brakes) | Complies |
| ISO 7176-4:2008 (Energy consumption/range) | Complies |
| ISO 7176-5:2008 (Dimensions, mass, maneuvering) | Complies |
| ISO 7176-6:2018 (Max speed, accel, decel) | Complies |
| ISO 7176-7:1998 (Seating & wheel dimensions) | Complies |
| ISO 7176-8:2014 (Static, impact, fatigue strengths) | Complies |
| ISO 7176-9:2009 (Climatic tests) | Complies |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Complies |
| ISO 7176-11:2012 (Test dummies) | Used for testing |
| ISO 7176-13:1989 (Coefficient of friction) | Used for testing |
| ISO 7176-14:2008 (Power & control systems) | Complies |
| ISO 7176-15:1996 (Information disclosure) | Complies |
| ISO 7176-16:2012 (Resistance to ignition) | Complies |
| ISO 7176-22:2014 (Set-up procedures) | Used for testing |
| ISO 7176-25:2013 (Batteries & chargers) | Complies |
| ISO 7176-21:2009 (EMC) | Complies |
| ANSI C63.27-2017 (Wireless Coexistence) | Complies |
| ISO 10993-5:2009 (Cytotoxicity) | Complies |
| ISO 10993-10:2021 (Skin Sensitization) | Complies |
| ISO 10993-23:2021 (Irritation) | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI algorithm or data. The performance testing is described as non-clinical testing to ensure compliance with relevant ISO standards. This typically involves testing of physical units of the device. Sample sizes for these types of engineering tests are not usually reported in the same way as for clinical trials or AI validation sets. Data provenance (country of origin, retrospective/prospective) is not applicable or provided.
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)
This is not applicable as there is no mention of a "test set" that requires expert-established ground truth. The acceptance is based on compliance with engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and testing described.
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
This is not applicable since the device is an electric wheelchair, not an AI-powered diagnostic or assistive tool for human "readers" or clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an electric wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to the measurement and safety requirements specified in the various ISO and ANSI standards listed. For example, for static stability, the ground truth is simply whether the device maintained stability under the specified test conditions.
8. The sample size for the training set
This is not applicable as the device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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).