(14 days)
The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.
The provided text describes the 510(k) summary for the MILLENIUM II mechanical wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and performance standards rather than clinical performance or AI algorithm validation. Therefore, many of the requested categories for AI/clinical study evaluation are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176, Part 1 | Voluntarily conducted |
| ISO 7176, Part 5 | Voluntarily conducted |
| ISO 7176, Part 15 | Voluntarily conducted |
| ISO 7176, Part 16 | Voluntarily conducted |
| ISO 7176, Part 93 | Voluntarily conducted |
| ISO 7176, Part 3 | To be completed pre-launch |
| ISO 7176, Part 8 | To be completed pre-launch |
2. Sample size used for the test set and the data provenance
The document indicates testing was performed on the device ("a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 - 11 was used"). This suggests a single device may have been tested using a standardized dummy setup.
Data Provenance: The tests are "Non-Clinical Tests," implying they were conducted in a laboratory or engineering setting by the manufacturer (NEXT Mobility LLC). There is no information on country of origin of the data beyond the manufacturer's location in Canton, MI, USA. The testing is for mechanical performance and safety, not involving human subjects or clinical data in the traditional sense. It's likely considered prospective testing of the device prototypes or production samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for mechanical wheelchair testing is established by adherence to specified parameters within international standards (ISO 7176 series), not by expert human interpretation.
4. Adjudication method for the test set
Not applicable. The testing involves standardized mechanical performance tests, which yield objective measurements against defined criteria. It does not involve human interpretation requiring adjudication.
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 a mechanical wheelchair, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical wheelchair, not an AI algorithm.
7. The type of ground truth used
The ground truth used for mechanical wheelchair testing is defined by the objective performance criteria and methodologies outlined in the ISO 7176 standards. This includes measures of strength, stability, durability, and other physical characteristics, with pass/fail criteria typically specified by the standard. The "ground truth" is adherence to these engineering standards.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI model.
In summary, the provided document is a 510(k) premarket notification for a mechanical wheelchair, which relies on demonstrating compliance with recognized international performance standards (ISO 7176) and substantial equivalence to a predicate device. It does not involve AI or clinical studies in the typical sense that would necessitate the detailed categories requested for human-AI interaction or algorithm validation.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).