(144 days)
The B-600 is rear 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.
The B-600 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-600 has an "H" frame, controlled by Curtis Instruments Controller, electronic regenerative disc brakes, and Micro Motor.
This document is a 510(k) summary for the Otto Bock B-600 Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or performance like an AI/ML medical device.
Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are not applicable or extractable from this document.
However, I can extract information related to the demonstration of technological characteristics and standards used.
Device: B-600 Powered Wheelchair
Predicate Device: Quickie Designs (Sunrise Medical) P200 (P220) Wheelchair (K924278)
Here's the information that can be extracted, adapting to the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Standards Complied With) | Reported Device Performance (Conclusion) |
|---|---|
| EN 12184 (Electric wheelchairs, scooters and their chargers - Requirements and test methods) | "the test sample fulfills the requirements." |
| ISO 7176 - Series (Wheelchairs - Test methods) | "the test sample fulfills the requirements." |
| ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Wheelchair standards for electromagnetic compatibility) | "the test sample fulfills the requirements." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a numerical count of wheelchairs tested, but it refers to "the test sample" which implies at least one B-600 Powered Wheelchair was subjected to the listed standards.
- Data Provenance: The standards testing was conducted by TÜV Product Service and Montena EMC SA. The device is manufactured in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a clearance for a powered wheelchair based on performance against established standards and substantial equivalence to a predicate device, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with engineering and safety standards, determined by testing facilities.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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 is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used:
- Compliance with established international and national standards for electric wheelchairs and electromagnetic compatibility (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML diagnostic device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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).