(144 days)
The C-1000 is front wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.
Provide mobility to persons physically challenged and limited to sitting position.
The C-1000 Powered Wheelchair is a front wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The C-1000 has an "H" frame, controlled by a Curtis Instruments MC-2, electronic regenerative disc brakes and Micro Motor.
The provided text describes a 510(k) submission for the Otto Bock C-1000 Powered Wheelchair, seeking clearance for marketing. The nature of this submission and the device itself (a powered wheelchair) means that the "acceptance criteria" and "device performance" are primarily related to safety, functionality, and equivalence to a predicate device, rather than diagnostic accuracy or predictive power as would be seen in a medical imaging AI product.
Therefore, many of the typical acceptance criteria points for an AI/ML device, such as sensitivity, specificity, AUC, and aspects related to human reader studies, are not applicable in this context. The study described focuses on compliance with established engineering and safety standards for wheelchairs.
Here's a breakdown of the requested information based on the provided text, acknowledging the differences due to the device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance: | |
| EN 12184 (Electrically-powered wheelchairs) | "the test sample fulfills the requirements." |
| ISO 7176 Series (Wheelchairs) | "the test sample fulfills the requirements." |
| ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Electromagnetic Compatibility) | "the test sample fulfills the requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "the test sample" was used, implying one or a small number of C-1000 Powered Wheelchair units were subjected to testing. A specific numerical sample size is not provided.
- Data Provenance: The device was manufactured in Germany at OTTO BOCK HealthCare production facilities. The testing was conducted by TÜV Product Service, an organization based in Europe, which suggests the tests were likely performed in Europe. This was a prospective study, as the tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not directly applicable here. The "ground truth" for the performance of a powered wheelchair is its adherence to established engineering and safety standards. The "experts" would be the engineers and technicians at TÜV Product Service who conducted the tests and assessed compliance with the specified standards. Their qualifications would be expertise in mechanical, electrical, and medical device safety testing, and specifically in the standards listed (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21). The number of such individuals is not specified.
4. Adjudication Method for the Test Set
- Not applicable in the context of compliance testing against engineering standards. The results are typically objective measurements against predefined limits or pass/fail criteria within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of a diagnostic aid (often AI-based) on human reader performance, which is not the purpose of this device or its clearance pathway.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The C-1000 Powered Wheelchair is a physical medical device, not an algorithm. Its performance is inherent to the device itself.
7. The Type of Ground Truth Used
- The "ground truth" used for assessing the device's performance was the requirements outlined in the recognized international and national engineering and safety standards:
- EN 12184 (Electrically-powered wheelchairs)
- ISO 7176 Series (Wheelchairs)
- ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Electromagnetic Compatibility)
8. The Sample Size for the Training Set
- Not applicable. The C-1000 Powered Wheelchair is a physical product designed and manufactured according to established engineering principles, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device. The design and manufacturing processes are guided by established engineering specifications and quality control measures, which ensure the device's intended characteristics.
§ 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).