(306 days)
The LEVO MAX power wheelchair is intended to provide indoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
The LEVO MAX power wheelchair is intended to provide indoor and outdoor mobility to persons limited to a sitting position, that are capable of operating a powered wheelchair.
The LEVO MAX powered wheelchair with optional seating and function is center wheel motor driven, battery powered, motor driven power wheelchair and is controlled by the PG Drives Technology's power wheelchair controller "R-net" or "VR2". The joystick user interface is integrated in the controller. The wheelchair is powered by two 12V/55Ah, 12V/73Ah or two 12V/75Ah batteries with a theoretical driving range of 25km (55Ah), 35km (72Ah); with fully charged batteries.
Components:The LEVO MAX power wheelchair consists of three basic sub-sections. These are: the base with drive units, the PG Drives Technology's R-NET or VR-2 Control System, and the body supporting system.
The base of the LEVO MAX includes: the frame, two direct-drive units with integrated parking brakes, two 12V/55Ah, two 12V/73Ah, or two 12V/75Ah batteries, two straight front and two center driving wheels as well as two twin rear caster wheels.
PG Drives Technology's VR2-Control System includes the power module, the integrated lighting module and the controller with integrated joystick. PG Drives Technology's R-NET Control System includes the power module, the intelligent seating/lighting module and the controller with integrated joystick.
The body supporting system includes the seat support, armrests and leg rests.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LEVO MAX power wheelchair:
The document is a 510(k) summary, which concerns medical device clearance in the US based on substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data. Therefore, the "study" described here is primarily a series of engineering and performance tests based on recognized standards.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the listed standards being "met," meaning the device passed the performance requirements specified in each standard. The document doesn't provide specific quantitative acceptance thresholds for each test, but rather states that the "Levo MAX functioned as intended" in all instances of the performed tests.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| RESNA WC-1:2009 Section 1: Determination of static stability | "Levo MAX functioned as intended" |
| RESNA WC-2:2009 Section 2: Determination of dynamic stability of electrically powered wheelchairs | "Levo MAX functioned as intended" |
| RESNA WC-2:2009 Section 3: Determination of effectiveness of brakes | "Levo MAX functioned as intended" |
| RESNA WC-2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical dis. | "Levo MAX functioned as intended" (Theoretical driving range reported as up to 35 km) |
| RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space | "Levo MAX functioned as intended" (Dimensions: 1300/620/1120 mm, Weight: 170 kg) |
| RESNA WC-2:2009 Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs | "Levo MAX functioned as intended" (Maximum Speed: Up to 12 km/h) |
| RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strength | "Levo MAX functioned as intended" |
| RESNA WC-2:2009 Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | "Levo MAX functioned as intended" (Obstacle climbing: 130mm) |
| RESNA WC-1:2009 Section 11: Test dummies | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces | "Levo MAX functioned as intended" |
| RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs Requirements and test methods. | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 16: Resistance to ignition of upholstered parts -Requirements and test methods | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 22: Set-up procedures | "Levo MAX functioned as intended" |
| RESNA WC-1:2009 Section 26: Vocabulary | "Levo MAX functioned as intended" |
| ISO 7176-1:1999: Wheelchairs Part 1: Determination of static stability | "Levo MAX functioned as intended" |
| ISO 7176-2:2001: Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs | "Levo MAX functioned as intended" |
| ISO 7176-3:2012: Wheelchairs Part 3: Determination of efficiency of brakes | "Levo MAX functioned as intended" |
| ISO 7176-4:2008: Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | "Levo MAX functioned as intended" (Theoretical driving range reported as up to 35 km) |
| ISO 7176-5:2008: Wheelchairs Part 5: Determination of overall dimensions, mass and turning space | "Levo MAX functioned as intended" (Dimensions: 1300/620/1120 mm, Weight: 170 kg) |
| ISO 7176-6:2001: Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | "Levo MAX functioned as intended" (Maximum Speed: Up to 12 km/h) |
| ISO 7176-7:1998: Wheelchairs Part 7: Measurement of seating and wheel dimensions | "Levo MAX functioned as intended" |
| ISO 7176-8:1998: Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths | "Levo MAX functioned as intended" |
| ISO 7176-10:2008: Wheelchairs Part 10: Determination of obstacle climbing ability of electric wheelchairs | "Levo MAX functioned as intended" (Obstacle climbing: 130mm) |
| ISO 7176-11:2012: Wheelchairs Part 11: Test dummies | "Levo MAX functioned as intended" |
| ISO 7176-13:1989: Wheelchairs Part 13: Determination of coefficient of friction of test surfaces | "Levo MAX functioned as intended" |
| ISO 7176-14:2008: Wheelchairs Part 14: Power and control systems for electric wheelchairs - Requirements and test methods | "Levo MAX functioned as intended" |
| ISO 7176-15:1996: Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling | "Levo MAX functioned as intended" |
| ISO 7176-16:2012: Wheelchairs Part 16: Resistance to ignition of upholstered parts 1-2 | "Levo MAX functioned as intended" |
| ISO 7176-19:2008: Wheelchairs Part 19 Wheeled Mobility Devices for use as seats in motor vehicles | "Levo MAX functioned as intended" |
| ISO 7176-22:2000: Wheelchairs Part22: Set-up procedures | "Levo MAX functioned as intended" |
| EN 12184:2009: Electrically powered wheelchairs, scooters an their chargers | "Levo MAX functioned as intended" |
| EN 12182:2012: Technical aids for disabled persons. General requirements and test methods | "Levo MAX functioned as intended" |
| **Upcoming Tests (before marketing):**RESNA WC-2:2009 Section 9: Climatic tests; RESNA WC-2:2009 Section 21: Electromagnetic compatibility; ISO 7176-9:2009: Climatic tests; ISO 7176-21:2009: Electromagnetic compatibility | "Testing will be conducted and meet the acceptance criteria of the following standards before the device is marketed" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in the conventional sense for clinical studies. It refers to a single device (the LEVO MAX) undergoing various engineering performance tests.
- Data Provenance: The tests were performed to international and national standards (ISO, RESNA, EN), which implies the testing environment would adhere to the specified protocols of these standards. The device manufacturer, LEVO AG, is based in Wohlen, Switzerland. The nature of these tests (e.g., static stability, dynamic stability, brake efficiency) indicates an engineering/benchtop testing environment, not human subject data. The testing is prospective in the sense that the device was actively tested against these standards for the purpose of seeking clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the "ground truth" for these engineering performance tests is defined by the objective physical and mechanical properties and performance of the device against the criteria outlined in the referenced standards. There is no subjective interpretation by human experts being adjudicated to establish ground truth in the way it would be for, e.g., image interpretation in an AI study. The tests are machine-measured or involve objective physical events.
4. Adjudication Method for the Test Set
- This is not applicable. The tests performed are objective engineering measurements and evaluations against predefined standard parameters. They do not involve subjective assessments requiring adjudication.
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
- This is not applicable. The device is a powered wheelchair, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). This document does not describe any MRMC study or AI component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This is not applicable. There is no "algorithm" or AI component described in the context of this device that would undergo standalone performance testing. The "performance data" refers to the physical performance of the mechanical and electrical system of the wheelchair.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for these tests is the quantitative and qualitative performance requirements specified within each referenced engineering standard (RESNA, ISO, EN). For example, a stability test would define the angle at which a wheelchair must remain stable, and the "ground truth" is whether the tested wheelchair meets or exceeds that angle. For speed, the ground truth is the measured speed compared to a specified maximum.
- Examples:
- Static Stability: The ground truth is the specified tilt angle(s) the wheelchair must withstand without tipping, as defined by the RESNA/ISO standard.
- Brake Effectiveness: The ground truth is the required stopping distance or holding capability on an incline, as specified by the standard.
- Dimensions/Weight: The ground truth is the actual measured dimensions and weight of the device.
- Examples:
8. The Sample Size for the Training Set
- This is not applicable. There is no AI or machine learning component described that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no training set for an AI model.
Summary of the Study:
The "study" presented here is a series of engineering performance tests conducted on the LEVO MAX power wheelchair. These tests evaluated the device's physical and mechanical characteristics and performance against internationally recognized standards (RESNA, ISO, and EN) for wheelchairs. The purpose was to demonstrate that the LEVO MAX is safe and effective and substantially equivalent to its predicate device, the Permobil M400, by showing it meets or exceeds the performance requirements outlined in these standards. The document explicitly states that "In all instances of the above mentioned test criteria, the Levo MAX functioned as intended," meaning it passed all conducted tests. Additional tests for climatic conditions and electromagnetic compatibility are planned before the device is marketed.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).