(105 days)
The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.
This document (K191874) is a 510(k) premarket notification for a powered wheelchair, the F5 Corpus VS. It compares the device to two predicates: the Quickie® Q700-UP M (K172384) and the F5 (K143014).
Based on the provided text, here is an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated by compliance with various ISO and RESNA standards for wheelchairs. The document does not present a single table explicitly listing "acceptance criteria" against "reported device performance" in a quantitative manner for all aspects. Instead, it states compliance with standards and provides some performance specifications when comparing the device to its predicates.
Here's an attempt to compile relevant information, though a direct "acceptance criteria" column is not explicitly defined in the document for each performance characteristic:
| Performance Characteristic | Acceptance Criteria (Implied by Standards) | Reported Device Performance (F5 Corpus VS) |
|---|---|---|
| Static Stability | Complies with ISO 7176-1:1999 | Complies with ISO 7176-1:1999 |
| Dynamic Stability | Complies with ISO 7176-2:2001 | Complies with ISO 7176-2:2001 |
| Brake Effectiveness | Complies with ISO 7176-3:2003 | Complies with ISO 7176-3:2003 |
| Energy Consumption / Theoretical Distance Range | Complies with ISO 7176-4:2008 | Complies with ISO 7176-4:2008 |
| Overall Dimensions, Mass, Maneuvering Space | Complies with ISO 7176-5:2008 | Complies with ISO 7176-5:2008 |
| Maximum Speed, Acceleration, Deceleration | Complies with ISO 7176-6:2001 | Complies with ISO 7176-6:2001 (Max speed: Up to 12 km/h (7.5 mph) forward, 4.4 km/hr (3 mph) reverse) |
| Seating and Wheel Dimensions | Complies with ISO 7176-7:1998 | Complies with ISO 7176-7:1998 |
| Static, Impact, Fatigue Strengths | Complies with ISO 7176-8:1998 | Complies with ISO 7176-8:1998 |
| Climatic Tests | Complies with ISO 7176-9:2009 | Complies with ISO 7176-9:2009 |
| Obstacle-Climbing Ability | Complies with ISO 7176-10:2008 | Complies with ISO 7176-10:2008 (Max obstacle height: 3" / 75 mm, not in standing mode) |
| Test Dummies | Complies with ISO 7176-11:2012 | Complies with ISO 7176-11:2012 |
| Coefficient of Friction of Test Surfaces | Complies with ISO 7176-13:1989 | Complies with ISO 7176-13:1989 |
| Power and Control Systems | Complies with ISO 7176-14:2008 | Complies with ISO 7176-14:2008 (PG R-Net PM 120 120Amp electronics) |
| Information Disclosure, Documentation, Labeling | Complies with ISO 7176-15:1996 | Complies with ISO 7176-15:1996 |
| Resistance to Ignition of Postural Support Devices | Complies with ISO 7176-16:2012 | Complies with ISO 7176-16:2012 |
| Wheeled Mobility Devices for Use as Seats in Motor Vehicles | Complies with ISO 7176-19:2008 | Complies with ISO 7176-19:2008 |
| Electromagnetic Compatibility (EMC) | Complies with ISO 7176-21:2009 | Complies with ISO 7176-21:2009 (20V/m modulated 80% AM) |
| Set-up Procedures | Complies with ISO 7176-22:2014 | Complies with ISO 7176-22:2014 |
| Batteries and Chargers | Complies with ISO 7176-25:2013 | Complies with ISO 7176-25:2013 (2 x 12V 73 Ah gel Group M24 battery) |
| Vocabulary | Complies with ISO 7176-26:2007 | Complies with ISO 7176-26:2007 |
| Performance of Stand-up Type Wheelchairs | Complies with RESNA WC-1:2009 Section 20 | Complies with RESNA WC-1:2009 Section 20 |
| Maximum Incline Angle | Maximum incline angle for safe operation | 9° |
| Driving Range | Acceptable driving range for powered wheelchairs | Up to 25 km (16 miles) on fully charged battery |
| Weight Bearing Capacity | Max user weight | 136 kg (300 lbs) |
| Turning Radius | Within acceptable limits for maneuverability | 762.5 mm (30") |
The document emphasizes that the F5 Corpus VS passes the requirements in ISO 7176 and RESNA WC-1:2009 Section 20.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document refers to "Non-Clinical Testing" which involves compliance with a long list of ISO standards and RESNA WC-1. These are physical performance tests for the device itself (e.g., stability, brake effectiveness, strength).
- Sample size for the test set: Not explicitly stated as a number of devices or units. Typically, for device performance testing against standards, a representative sample (e.g., a few units or prototypes) is tested. The nature of these tests does not involve patient data or human subjects for the "test set" in the context of an AI/algorithm study.
- Data provenance: Not applicable in the context of patient data for an algorithm. The tests are for the physical wheelchair device. The Permobil AB company is based in Sweden. The tests were conducted to international standards.
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 information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance of the device as measured by standardized engineering and safety tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm study involving adjudication of clinical findings. Compliance with standards is typically measured objectively through specified test procedures.
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 information is not applicable. The device is a physical powered wheelchair. There is no AI component or human reader in the context of medical image interpretation that would warrant an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical powered wheelchair, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the F5 Corpus VS device is its physical performance, safety, and functional characteristics as measured and validated against established international standards (ISO 7176 series and RESNA WC-1:2009 Section 20). These standards define objective test methods and acceptable performance limits.
8. The sample size for the training set
This information is not applicable. The device is a physical powered wheelchair. There is no AI/algorithm being trained on a dataset. The design and manufacturing process would involve engineering principles and testing, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as in point 8.
§ 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).