(14 days)
The LEVO comfort II stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.
The LEVO comfort II power wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the PG Drives Technology's power wheelchair controller "VSI" The Joystick is integrated in the Controller. The wheelchair is powered by: two 12V/26Ah, two 12V/40Ah or four 12V/26Ah batteries with a theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries.
The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
- PG Drives Technology's power wheelchair controller . "VSI"
- Seating System including stand-up mechanisms and actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.
The LEVO comfort II is a stand-up power wheelchair. The provided text indicates that the device's safety and effectiveness were established primarily through substantial equivalence to predicate devices, namely the LEVO mobil LCM (K 963817) and Quickie Freestyle (K 031289). No specific acceptance criteria with quantifiable metrics or a detailed study evaluating the device against such criteria are explicitly provided in the furnished document.
The document states: "The LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness." This implies that the device is considered safe and effective because its core design and performance are substantially similar to previously cleared devices, with only minor aesthetic and functional improvements that do not introduce new safety or effectiveness concerns.
Therefore, many of the specific details requested in the prompt, such as
- a table of acceptance criteria and reported device performance,
- sample sizes for test sets,
- details of experts and adjudication methods,
- MRMC studies,
- standalone performance studies,
- ground truth types,
- training set sample sizes, and
- ground truth establishment for training sets,
are not present in the provided 510(k) summary. These types of detailed studies are typical for novel devices or those with significant changes that might impact safety or effectiveness. For devices demonstrating substantial equivalence to existing products with minor modifications, such extensive testing might not be required or documented in the summary.
The only performance-related detail mentioned is a "theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries," which describes a characteristic rather than a performance target against a predefined criterion.
Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for safety and effectiveness | "has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s)" |
| Ability to change users' position from sitting to standing and vice versa | Explicitly stated as a function of the device |
| Indoor and outdoor mobility | Explicitly stated as a function of the device |
| Driving range (theoretical) | 14km (26Ah), 20km (40Ah), 28km (56Ah) |
| No new questions of safety and effectiveness raised by modifications | "the minor changes declared in the Submission do not raise new questions of safety and effectiveness." |
Study Information (Based on provided text):
- Sample size used for the test set and the data provenance: Not explicitly stated. The determination of safety and effectiveness appears to be based on a comparison to predicate devices, rather than a new standalone test set for empirical performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical efficacy or safety studies with expert ground truth establishment are not mentioned for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the predicate devices.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as detailed testing requiring adjudication is not described.
- 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 device is a physical medical device (power wheelchair), not an AI/software-based diagnostic or assistive system that would involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used: Substantial equivalence to predicate devices (LEVO mobil LCM and Quickie Freestyle). The safety and effectiveness of these predicate devices serve as the "ground truth."
- The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.
- How the ground truth for the training set was established: Not applicable.
§ 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).