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510(k) Data Aggregation
(16 days)
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
This document is a 510(k) premarket notification for mechanical wheelchairs (GEN 2 and GEN 3 models). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on an AI/ML powered device.
Therefore, many of the requested elements (acceptance criteria, sample size for test/training sets, ground truth establishment, expert qualifications, MRMC comparative effectiveness, standalone performance, etc.) are not applicable or not provided in this document.
However, I can extract information related to the performance testing conducted for these mechanical wheelchairs.
Acceptance Criteria and Reported Device Performance
The document describes non-clinical testing performed to establish the safety and effectiveness of the modified GEN 2 and GEN 3 mechanical wheelchairs. The specific acceptance criteria are implied by adherence to the ISO 7176-1:2014 standard for static stability.
| Acceptance Criteria (Implied by standard) | Reported Device Performance (Implied by conclusion) |
|---|---|
| Compliance with ISO 7176-1:2014 for static stability. | Retesting was performed in accordance with ISO 7176-1:2014 (forward, rearward, and lateral static stability tests). |
| Device modifications do not affect performance. | The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing... The modification does not affect the performance of the devices. |
| Device modifications do not raise new safety/effectiveness questions. | Non-clinical test results demonstrate the modified GEN 2 and GEN 3 Mechanical Wheelchairs do not raise any issues regarding safety and effectiveness. |
Note: The document explicitly states "The information provided supports a substantial equivalence decision based on the repeat pre-clinical testing of the forward, rearward and lateral static stability tests performed in accordance with ISO 7176-1:2014." This implies that the devices met the requirements of this standard.
The other questions are not relevant to this document as it pertains to physical medical devices (mechanical wheelchairs) and not an AI/ML powered device.
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