(144 days)
The B-500 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.
Provide mobility to persons physically challenged and limited to sitting position.
The B-500 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-500 has an "H" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.
This document does not contain an acceptance criteria table or a study description as typically found for complex medical devices that rely on AI or extensive performance testing against defined metrics.
Instead, this document is a 510(k) summary for a powered wheelchair (B-500 Powered Wheelchair) seeking market clearance through the substantial equivalence pathway. The "study" mentioned for this type of device is usually compliance with recognized international and national standards, rather than a clinical trial or performance study against specific acceptance criteria in the way a diagnostic AI algorithm would be evaluated.
Here's a breakdown of the information that is present in the document, formatted to address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Conclusion) |
|---|---|
| EN 12184 | "the test sample fulfills the requirements." |
| ISO 7176 Series | "the test sample fulfills the requirements." |
| ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC | "the test sample fulfills the requirements." |
Explanation: For a powered wheelchair, "acceptance criteria" are typically defined by compliance with established safety and performance standards. The document states that the B-500 was tested by TÜV Product Service to the listed standards, and the conclusion was that "the test sample fulfills the requirements." This indicates that the device met the requirements outlined in these standards, which serve as the de facto acceptance criteria for this type of medical device.
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a "test set sample size" or "data provenance" in the context of clinical data or AI model evaluation. The "test sample" refers to the physical wheelchair(s) that underwent testing against the specified engineering standards. The typical number of units tested for such compliance would be a limited number of production or prototype units, not a large patient cohort.
- Sample Size: Not explicitly stated, but typically a small number of physical units for engineering standard compliance testing.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed by TÜV Product Service. The manufacturing location is stated as Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this document. The "ground truth" for a powered wheelchair's compliance is determined by its adherence to engineering standards and functional performance, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable. The testing was against engineering and safety standards, not a clinical trial requiring adjudication of patient outcomes or interpretations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This document describes a powered wheelchair, which is a therapeutic device, not a diagnostic one.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Standalone performance, in the context of an algorithm, is not applicable to this device. The B-500 is a physical device, and its performance is evaluated through physical testing against standards, not through an algorithm's output.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is its compliance with established engineering and safety standards (EN 12184, ISO 7176 Series, and ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).
8. Sample Size for the Training Set
This information is not applicable. The device manufacturing process does not involve a "training set" in the context of AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
§ 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).