(100 days)
The LSC Lifestand Compact offers electrical 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 Lifestand Compact is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels using independent motors. Front castors support the front of the chair and allow indirect steering through the turning hack wheels. The system is controlled with a standard e-fix wheelchair controller, with direct user operation through standard wheelchair joystick. Two high quality maintenance-free watertight rechargeable electrolyte gel batteries, connected in series, supply the energy for the system. A Lincar actuator drives the seat into seating or standing position. Another linear actuator drives the backrest into an individual seating-inclination. Both linear actuators are also direct user operated through the standard wheelchair ion: Dots.
Chassis: Rigid, made from treated steel with epoxy resin paint
Tibia support: adjustable in height and inclination
Seat: Depth adjustable with cushion
Backrest: electrically adjustable
Armrest: Retractable, can be converted to adjustable chest support
Footrest: Height can be adjusted
Upholstery: Fire-resistant (M4), washable fabric
Front wheels: diameter 7" x 1 3/4"
Rear wheels: diameter 12 1/2" x 2 1/4"
Brakes: manual by pushing and electromagnetic in the back wheels
User weight: max. 120kg
Idle weight: 76kg
Batteries: 2x12V, 17Ah, watertight rechargeable electrolyte gel batteries
Driving-motor: e-fix by Ulrich Alber GmbH + Co. KG – Germany, 24V DC
Linear actuator seat: Linac LA 31.1
Linear actuator back: Linac 314210
The provided document describes a 510(k) premarket notification for the LSC Lifestand Compact, an electrically powered standup wheelchair. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| EN 12184: 1999 Electrically powered wheelchairs, scooters and their chargers requirements and test methods | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 12182: 1999 Technical aids for disabled persons - general requirements and test methods | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-1: 1999-10-01 Determination of static stability | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-2: 2001-06-15 Determination of dynamic stability of electric wheelchairs | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-3: 1988-11-15 Determination of efficiency of brakes | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-4: 1997-12-15 Energy consumption of electric wheelchairs and scooters for determination of theoretical distance | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-5: 1986-03-01 Determination of overall dimensions, mass and turning space | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-6: 2001-10-01 Determination of maximum speed, acceleration and deceleration of electric wheelchairs | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-7: 1998-05-15 Measurement of seating and wheel dimensions | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-8: 1998-07-15 Static, impact and fatigue strength | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-9: 2001-10-15 Climatic tests for electric wheelchair | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-10: 1988-11-15 Determination of obstacle-climbing ability of electric wheelchairs | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-14: 1997-10-15 Power and control systems for electric wheelchairs – Requirements and test methods | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 7176-15: 1996-11-00 Requirements for information disclosure, documentation and labeling | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO/CD 7176-20: 2001-07-06 Determination of the performance of stand-up type wheelchairs | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ANSI/RESNA WC/Vol. 2-1998 Section 21 Requirements and Test Methods for Electromagnetic Compatibility of Electric Wheelchairs and Scooters | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 55011: 1998 Limits and methods of measurement of radio disturbance characteristics of information technology equipment | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| CISPR 11: 1997 Industrial, scientific and medical (ISM) radio-frequency equipment – Radio disturbance characteristics – Limits and methods of measurement, Amendment No. 1 (1999) | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 61000-4-2: 1995 Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 2: Electrostatic discharge immunity test | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 60601-4-3: 1996 Electromagnetic Compatibility (EMC), Part 4: Testing and measuring techniques, Section 3: Radiated, radio-frequency electromagnetic field immunity test | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 60335: 1995 Specification for safety of household and similar electrical appliances | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 50081-1: 1993 Electromagnetic compatibility. Generic emission standard. Residential, commercial and light industry | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN 50082-2: 1996 Electromagnetic compatibility. Generic immunity standard. Industrial environment | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| EN ISO 10993-5: 1999 Biological evaluation of medical devices. Tests for in vitro cytotoxicity | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| NFX 41002 Resistance to salt spray fog | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| NFP 92503 flammability | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| NFP 92505 flammability | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
| ISO 6941:1984 Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens | "The following tests where performed on the LSC standup wheelchair to approve its safety" (Implicitly, the device met the requirements of this standard to obtain approval). |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical tests performed on the LSC Lifestand Compact. The document states: "The following tests where performed on the LSC standup wheelchair to approve its safety" and then lists a comprehensive set of national and international standards related to electrically powered wheelchairs, general technical aids for disabled persons, and various aspects of safety, performance, and electromagnetic compatibility.
The implicit finding from this submission is that the LSC Lifestand Compact successfully met the requirements of all listed standards, thereby demonstrating its safety and effectiveness for its intended use, and establishing substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size of the LSC Lifestand Compact devices used for these non-clinical tests. Typically, for such product safety and performance testing against standards, a representative sample (often one or a few units) of the manufactured device is subjected to the tests.
- Data Provenance: The tests are non-clinical, meaning they were performed on the device itself, not on human subjects. The company is based in France ("Lifestand Rond Point de Rosarge 40, rue Palverne F-01700 Les Echets - France"), suggesting the testing may have occurred in Europe or by laboratories accredited to perform these standards. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
These are non-clinical engineering and performance tests, not clinical studies involving expert interpretation of data like medical imaging. Therefore, the concept of "experts establishing ground truth" in the clinical sense does not apply here. The "ground truth" for these tests is defined by the objective pass/fail criteria set forth in each listed international and national standard. The evaluations would have been performed by qualified testing personnel and engineers, whose qualifications would be in the field of mechanical, electrical, and materials engineering, and testing methodologies specific to medical devices and wheelchairs.
4. Adjudication Method for the Test Set
Not applicable. Since these are objective performance tests against predefined standards, there is no "adjudication method" in the sense of resolving discrepancies between human readers or experts. The outcome of each test is determined by whether the device's performance meets the specified thresholds or criteria in the respective standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is a type of clinical study typically used to compare the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm when interpreting medical data. This document describes the non-clinical testing of a physical medical device (an electric wheelchair) against established engineering and safety standards. No clinical studies, and therefore no MRMC studies, were performed or are relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical, electrically powered wheelchair; it is not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
For non-clinical performance and safety testing of a physical device, the "ground truth" is established by the objective, predefined pass/fail criteria and specifications outlined in the referenced national and international standards (e.g., EN 12184, ISO 7176 series, ANSI/RESNA, EN 61000, etc.). For example, the "ground truth" for static stability (ISO 7176-1) would be the device remaining stable under specific load and incline conditions, as defined by that standard.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied in this document. The device is a physical product, not an AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and submission.
§ 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).