(119 days)
Provide mobility to persons physically challenged and limited to sitting positions due to:
- Palsies/Paralyses
- Loss of limbs
- Defective and/or deformed limbs
- Joint contractures
- Joint defects
- Other diseases
The C2000 power wheelchair is suitable for indoor and outdoor use. It is compactly designed and easy to maneuver for use indoors. Two 12 V batteries power its high-performance drive system, which allows the C2000, along with spring mounted drive wheels, to overcome obstacles (category C of EN 12184) and to ensure safe operation.
The C2000 power wheelchair is controlled by an enAble50 wheelchair control system. It includes a control panel to enter driving commands and display the current status as well as a controller that controls that drive motors and other electrical functions based on the input data. Data transmission is realized via a bus system.
The enAble50 can be programmed to the personal requirements of the user; e. g. the speed, acceleration and deceleration values can all be personalized.
This document describes a 510(k) submission for the Otto Bock C2000 Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device (C1000 Powered Wheelchair) and meeting safety standards, rather than proving the performance of an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| DIN EN 12184:1999 (Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods) | Complies |
| IEC 60601-1-4 (Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems) | Complies |
| ISO 7176-1:1999 (Wheelchairs - Part 1: Determination of static stability) | Complies |
| ISO 7176-3:2003 (Wheelchairs - Part 3: Determination of effectiveness of brakes) | Complies |
| ISO 7176-5:2008 (Wheelchairs - Part 5: Determination of dimensions, mass and manoeuvring space) | Complies |
| ISO 7176-7:1998 (Wheelchairs - Part 7: Measurement of seating and wheel dimensions) | Complies |
| ISO 7176-8:1998 (Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength) | Complies |
| ISO 7176-10:2008 (Wheelchairs - Part 10: Determination of the range of travel and maximum speed of electric wheelchairs) | Complies |
| ISO 7176-11:1992 (Wheelchairs - Part 11: Test dummies) | Complies |
| ISO 7176-13:1989 (Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces) | Complies |
| ISO 7176-14:2008 (Wheelchairs - Part 14: Power and control systems for electric wheelchairs - Requirements and test methods) | Complies |
| ISO 7176-15:1996 (Wheelchairs - Part 15: Requirements for information disclosure and labelling) | Complies |
| ISO 7176-16:1997 (Wheelchairs - Part 16: Resistance to ignition of upholstered parts - Requirements and test methods) | Complies |
| ISO 7176-21:2003 (Wheelchairs - Part 21: Requirements for medical devices for the disabled which carry out a patient transfer function) | Complies |
| ISO 7176-21:2007 (Wheelchairs - Part 21: Requirements for medical devices for the disabled which carry out a patient transfer function) | Complies |
| CE certification | Confirmed |
| Ability to overcome obstacles (category C of EN 12184) | Ensures safe operation |
2. Sample size used for the test set and the data provenance
The document refers to testing conducted to various EN and ISO standards for wheelchairs. These standards typically involve a defined number of test samples (devices) to evaluate performance and safety characteristics. However, the exact "sample size" of wheelchairs tested is not specified in this summary.
The data provenance is from testing conducted by TÜV in Hanover, Germany. This indicates the data is from a prospective testing process following established engineering and safety standards, rather than a clinical dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm for diagnostic purposes. "Ground truth" in this context refers to compliance with established engineering and safety standards, which are evaluated through standardized tests and measurements, not expert human interpretation of data. The "experts" would be the engineers and technicians performing the tests at TÜV.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert interpretations of medical images or data, which is not relevant to the testing of a physical medical device against engineering standards. The compliance is determined by whether the device passes the specified tests.
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 information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" used for this device is based on established international and European engineering safety and performance standards (DIN EN, IEC, ISO). The device's performance is measured directly against the requirements and test methods defined within these standards.
8. The sample size for the training set
This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical device submission for a powered wheelchair, not an AI/ML algorithm that requires a training set.
§ 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).