(15 days)
The LEVO C3 power wheelchair with optional seating and standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.. The LEVO C3 power wheelchair is a product which changes people's position in/from seating or/to standing but also any position in between. The product provides high indoor and outdoor mobility.
The LEVO C with optional seating and standing position function is center wheel driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "VR2". The joystick is integrated in the controller. The wheelchair is powered by two 12V/55Ah or two 12V/72Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah). The electrical positioning change is integrated in an electrical center wheel drive power wheelchair that performs high indoor and outdoor mobility in any optional possible position. For security, the speed is reduced to half speed as soon as the patient is not in the sitting position.
This document primarily describes a 510(k) submission for a medical device, the LEVO C3 power wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of algorithm or diagnostic device evaluation.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in this type of regulatory document.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of quantitative acceptance criteria and reported device performance in terms of accuracy, sensitivity, specificity, etc., as one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are compliance with established safety and performance standards for power wheelchairs, and the "reported performance" is that the device meets these standards and is substantially equivalent to predicate devices.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Inferred) |
|---|---|
| Compliance with ISO, EN, and ANSI/RESNA standards for power wheelchairs. | The LEVO C3 has been tested after the latest ISO, EN and ANSI/RESNA standards. |
| Substantial equivalence to predicate devices (LEVO combi, LEVO comfort II, Permobil C350 PS) in technological characteristics, safety, and effectiveness. | The LEVO C3 has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s). Minor changes do not raise new questions of safety and effectiveness. |
| Speed reduction to half speed when not in sitting position for security. | For security, the speed is reduced to half speed as soon as the patient is not in the sitting position. |
| Ability to change people's position in/from seating or/to standing and any intermediate position. | The product changes people's position in/from seating or/to standing but also any position in between. |
| Provides high indoor and outdoor mobility on surfaces like tar, grass and gravel. | Provides high indoor and outdoor mobility on surfaces like tar, grass and gravel. |
| Not allowed to drive in standing position on uneven ground. | It is not allowed to drive in standing position on uneven ground. |
| Low shearing design to prevent shearing forces or dislocations during changing positions. | The whole body support system is equipped with the latest low shearing design to prevent shearing forces or dislocations during changing positions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes compliance with standards and equivalence to predicate devices, which typically involves engineering testing and comparative analysis, not a clinical "test set" in the sense of human subject data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. "Ground truth" in this context would likely refer to the established specifications and performance expectations outlined in the relevant ISO, EN, and ANSI/RESNA standards, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The "test set" described is a regulatory and engineering compliance process, not a clinical study requiring adjudication of expert interpretations.
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 physical medical device (power wheelchair), not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is implicit in the international and national standards (ISO, EN, ANSI/RESNA) that govern the safety and performance of power wheelchairs. These standards define the acceptable range of physical, mechanical, and electrical characteristics, as well as safety features.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set. The design of the LEVO C3 is based on "experience from the past" and previous models (LEVO combi, LEVO comfort II), which can be considered an analogous "training" or experience base for the engineering design, but not a data set in the AI sense.
9. How the ground truth for the training set was established
Not applicable in the AI sense. The "ground truth" for the engineering design and development came from "Experience from the past has shown" and "Experience from the past has shown that the centre wheel driven power wheel chair has the most compact and efficient manoeuvrability capability with some limitations...". This refers to empirical knowledge gained from previous product development and market use of their own and competitor's wheelchairs.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).