(168 days)
The LSC offers electrically powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position.
The provided document describes the LSC device, a powered standup wheelchair, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission.
This document is a 510(k) summary for a physical medical device (a wheelchair). The Acceptance Criteria and Study sections below are tailored to what is presented in the document regarding the device's conformity to standards and safety/effectiveness, rather than AI-specific performance metrics.
Here's the information extracted and interpreted based on the provided text:
1. A table of acceptance criteria and the reported device performance
For the LSC powered standup wheelchair, the "acceptance criteria" are the specific requirements and test methods outlined in various EN and ISO standards for wheelchairs. The "reported device performance" is the successful completion of tests according to these standards, as stated: "To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies."
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance |
|---|---|
| EN 12182: 1999 - Technical aids for disabled persons. General requirements and test methods | Tests performed according to standard |
| EN 12184: 1999 - Electrically powered wheelchairs, scooters and their chargers - requirements and test methods | Tests performed according to standard |
| ISO 7176-1: 1999 - Wheelchairs. Determination of static stability | Tests performed according to standard |
| ISO 7176-2: 2001 - Wheelchairs. Determination of dynamic stability of electric wheelchairs | Tests performed according to standard |
| ISO 7176-3: 1988 - Wheelchairs. Determination of effectiveness of brakes | Tests performed according to standard |
| ISO 7176-4: 1997 - Wheelchairs. Energy consumption of electric wheelchairs and scooters for theoretical distance | Tests performed according to standard |
| ISO 7176-5: 1986 - Wheelchair tests. Methods for determination of overall dimensions, mass and turning space | Tests performed according to standard |
| ISO 7176-6: 2001 - Wheelchairs. Determination of maximum speed, acceleration and deceleration | Tests performed according to standard |
| ISO 7176-7: 1998 - Wheelchairs. Measurement of seating and wheel dimension | Tests performed according to standard |
| ISO 7176-8: 1998 - Wheelchairs. Requirements and test methods for static, impact and fatigue strength | Tests performed according to standard |
| ISO 7176-9: 2001 - Wheelchairs. Climatic test for electric wheelchairs | Tests performed according to standard |
| ISO 7176-10: 1988 - Wheelchairs. Determination of obstacle-climbing ability of electric wheelchairs | Tests performed according to standard |
| ISO 7176-14: 1997 - Power and Control systems for electric wheelchairs – Requirements and test methods | Tests performed according to standard |
| ISO 7176-15: 1996 - Wheelchairs. Requirements for information disclosure, documentation and labeling | Tests performed according to standard |
| ISO 7176-16: 1997 - Wheelchairs - Part 16: Resistance to ignition of upholstered parts | Tests performed according to standard |
| ISO 7176-20: 2001 - Wheelchairs. Determination of the performance of stand-up type wheelchairs | Tests performed according to standard |
| ISO 7176-21: 2003 - Wheelchairs. Requirements and test methods for electromagnetic compatibility | Tests performed according to standard |
| EN ISO 10993-1: 2003 - Biological evaluation of medical devices. Evaluation and testing | Tests performed according to standard |
| EN ISO 10993-5: 1999 - Biological evaluation of medical devices. Tests for in vitro cytotoxicity | Tests performed according to standard |
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 explicitly detailed in the provided 510(k) summary for each specific test mentioned. For physical devices, compliance with standards often involves testing a specific number of units from a production batch, rather than data sets in the AI/ML context. The tests were performed "at test-laboratories of European notified bodies," implying European provenance. The nature of these tests (e.g., fatigue, stability, brake effectiveness) suggests a controlled laboratory environment.
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 is not applicable to the type of device and testing described. The "ground truth" here is objective physical measurements and adherence to engineering and safety standards, performed by qualified personnel at accredited test laboratories, not by medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are based on objective performance metrics against established standards, not on expert consensus or adjudication of subjective data.
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 (wheelchair), not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.
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 concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is adherence to established international and European standards (EN and ISO) for wheelchairs, which involve objective physical measurements, mechanical stress tests, electrical component tests, and biological safety evaluations.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device and does not involve a training set or corresponding ground truth establishment in the AI/ML sense.
§ 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).