(125 days)
The LSA Helium offers 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 LSA Helium is a manually propelled standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the chair and allow indirect steering through the turning back wheels. A gas-spring-system supports the customer in putting the seat manually into a seating or standing position.
The provided document describes a 510(k) premarket notification for a medical device, the LSA Helium manually propelled standup wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical efficacy or performance beyond established safety standards. Therefore, many of the typical "acceptance criteria" and "study" components you'd expect for a novel AI/software medical device are not applicable here.
Here's a breakdown based on the information provided, highlighting the differences:
The "acceptance criteria" in this context refer to compliance with internationally recognized safety and performance standards for wheelchairs, rather than specific performance metrics for an AI algorithm. The "study" is the battery of non-clinical tests performed to meet these standards.
1. Table of Acceptance Criteria (Standards) and Reported Device Performance (Compliance):
| Acceptance Criteria (Standard) | Description | Reported Device Performance (Compliance) |
|---|---|---|
| EN 12182: 1999 | Technical aids for disabled persons. General requirements and test methods | Performed at test-laboratories of European notified bodies. |
| EN 12183: 1999 | Manually propelled wheelchairs. Requirements and test methods | Performed at test-laboratories of European notified bodies. |
| ISO 7176-1: 1999 | Wheelchairs. Determination of static stability | Performed at test-laboratories of European notified bodies. |
| ISO 7176-3: 1988 | Wheelchairs. Determination of effectiveness of brakes | Performed at test-laboratories of European notified bodies. |
| ISO 7176-5: 1986 | Wheelchair tests. Methods for determination of overall dimensions, mass and turning space | Performed at test-laboratories of European notified bodies. |
| ISO 7176-7: 1998 | Measurement of seating and wheel dimension | Performed at test-laboratories of European notified bodies. |
| ISO 7176-8: 1998 | Wheelchairs. Requirements and test methods for static, impact and fatigue strengths | Performed at test-laboratories of European notified bodies. |
| ISO 7176-15: 1996 | Wheelchairs. Requirements for information disclosure, documentation and labeling | Performed at test-laboratories of European notified bodies. |
| ISO 10993-5: 1999 | Biological evaluation of medical devices. Tests for in vitro cytotoxicity | Performed at test-laboratories of European notified bodies. |
| NFP 92503: | Flammability (Specific test method not detailed) | Performed at test-laboratories of European notified bodies. |
| NFP 92505: | Flammability (Specific test method not detailed) | Performed at test-laboratories of European notified bodies. |
| ISO 6941: 2003 | Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens | Performed at test-laboratories of European notified bodies. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The phrasing "tests according to current applicable standards where performed at test-laboratories" implies that the device (or representative samples) underwent testing as prescribed by these standards, which typically involve specific sample sizes or test configurations defined within the standard itself.
- Data Provenance: The tests were performed at "test-laboratories of European notified bodies." This indicates an external, accredited testing facility within Europe. The tests are non-clinical (i.e., not involving human subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This pertains to an AI/software device where ground truth is typically established by human experts reviewing medical images or patient data. For a physical medical device like a wheelchair, "ground truth" refers to the objective physical measurements and mechanical properties as defined by the engineering standards. The "experts" are the technicians and engineers at the notified body laboratories who conduct the tests according to the standard protocols. Their qualifications are inherent in the accreditation of the notified body.
4. Adjudication Method for the Test Set:
- Not applicable. This term is usually relevant for clinical studies or AI performance evaluations where there can be disagreement among reviewers or a need for a consensus mechanism. For compliance with engineering standards, the results are typically objective measurements against defined pass/fail criteria.
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:
- No. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in diagnostics. The LSA Helium is a physical mobility device and does not involve "human readers" or "AI assistance" in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As an entirely mechanical device, there is no "algorithm" to be evaluated in a standalone manner.
7. The type of ground truth used:
- Engineering Standards and Objective Measurements: The "ground truth" for this device's compliance is defined by the specific parameters, test methods, and acceptance limits outlined in the referenced EN and ISO standards (e.g., static stability, brake effectiveness, dimensions, strength, flammability). The tests yield objective, measurable data that is compared against these predetermined criteria.
8. The sample size for the training set:
- Not applicable. This is a non-AI/ML device. There is no "training set" in the context of an algorithm learning from data. The device itself is designed and manufactured, and then tested for compliance.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set.
Summary of the Study:
The "study" described is a series of non-clinical performance tests conducted to demonstrate that the LSA Helium manually propelled standup wheelchair meets internationally recognized safety and performance standards for such devices. These tests were performed by accredited European notified bodies. The purpose was to show substantial equivalence to a legally marketed predicate device (LEVO Active Easy, K971873) by demonstrating compliance with established (non-AI/ML specific) medical device standards. Clinical tests were explicitly stated as NOT performed.
§ 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).