(129 days)
The Bariatric Power Positioning System is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant.
The Bariatric Power Positioning System (BPPS) is a seating system which is added to a power wheelchair base to provide two basic functions: power tilt, and power recline including shear reduction. Note the BPPS in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.
The power Tilt function causes the position of the occupant to change by tilting the whole seat, including the seat pan, backrest, foot supports, and arm supports. The range of tilt is 0° to 50°.
The power Recline function causes the position of the occupant's back to changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The latter is accomplished by using a linkage that slides the backrest down on the back posts as the back recline function is also useful for the redistribution of pressure and providing improved body position for certain user activities. The range of Recline is 90° to 150°.
The maximum occupant weight for the Bariatric Power Positioning System is up to 400 lb depending on the wheelchair powerbase and seating features selected. The BPPS is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.
The power positioning modules may be activated via two options: using separate switches or through the wheelchair base manufacturer's joystick control.
Safety features include a drive lock-out which prevents the power chair while tilted or reclined beyond a certain pre-set limit. Electrical components are maximum 24 volts and include a current limiter in the relay box. Stability of the Bariatic Power Positioning System was tested on wheelchair powerbases commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Bariatric Power Positioning System.
The provided text describes the Bariatric Power Positioning System (BPPS), a seating system for power wheelchairs, and its substantial equivalence to a predicate device (Modular Power Positioning System - MPPS). The focus of the provided document is regulatory clearance (510(k)) and not a comprehensive clinical study report for a diagnostic AI device. Therefore, much of the requested information about AI model performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies is not applicable or available in this document.
However, I can extract information related to the device's acceptance criteria and the non-clinical studies proving its performance against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BPPS largely revolve around meeting relevant ANSI/RESNA standards for powered wheelchairs, biocompatibility, electrical safety, and functional performance comparable to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard / Parameter) | Reported Device Performance (BPPS) |
|---|---|---|
| Functional Performance | Power Tilt Range: 0° to 50° | 50° |
| Power Recline Range: 90° to 150° | 150° | |
| Max Occupant Weight: Up to 400 lbs (depending on powerbase) | Up to 400 lbs (tested, with system stability within accepted range) | |
| Seat Width Range | 20 to 26 inches | |
| Seat Depth Range | 16 to 23 inches | |
| Back Height Range | 18 to 30 inches | |
| Drive Lock-out (DLO) trigger | Included, functions to disable drive system when seating system reaches pre-set position | |
| Reduced Drive Speed (RDS) trigger | Included, restricts speed to 25%-30% | |
| Mechanical Safety and Stability | ANSI/RESNA WC-1:2009 Section 1: Determination of Static Stability | Compliant (wheelchair remains stable with fully tilted and reclined seat; center-of-gravity shift further enhances stability) |
| ANSI/RESNA WC-2:2009 Section 2: Determination of Dynamic Stability Of Electrically Powered Wheelchairs | Compliant | |
| ANSI/RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | Compliant | |
| ANSI/RESNA WC-1:2009 Section 13: Determination of Coefficient Friction of Test Surfaces | Compliant | |
| Biocompatibility | ISO 10993 Part 5: Testing for in vitro cytotoxicity | Cytotoxicity testing performed, compliant |
| ISO 10993 Part 10: Tests for irritation and skin sensitization | Dermal Sensitization and/or Primary Skin Irritation testing performed, compliant | |
| Electrical Safety & EMC | RESNA Section 21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters | Compliant (Electromagnetic Compatibility testing conducted) |
| Electrical components max voltage | 24 volts | |
| Current limiter in relay box | Included | |
| Software Validation | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Moderate level of concern) | Software verification and validation testing conducted and documentation provided. |
| Climatic Tests | ANSI/RESNA WC-2:2009 Section 9: Climatic Tests for Electrically Powered Wheelchairs | Compliant |
| Ignition Resistance | ANSI/RESNA WC-1:2009 Section 16 Resistance to Ignition of Upholstered Parts, or EN 12184:2014 section 8.10 Resistance to Ignition | Compliant |
| EN 1021-1/-2:2014: Testing of Ignitability For Upholstered Furniture | Compliant | |
| California Technical Bulletin 117-2013: Requirements, Test Procedure and Apparatus For Testing The Smolder Resistance Of Materials Used In Upholstered Furniture | Compliant | |
| Information Disclosure | ANSI/RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, Documentation and Labeling | Compliant |
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 applicable as this is a mechanical medical device, not a diagnostic AI device requiring a test set of data. The testing involved physical devices and materials, not data.
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 this is a mechanical medical device. The "ground truth" for this device is based on compliance with established engineering and safety standards (e.g., ANSI/RESNA, ISO) and functional verification, not on expert interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is a mechanical medical device. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic imaging, which is not relevant here.
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
A multi-reader multi-case (MRMC) study is not applicable/was not done for this device. This type of study is relevant for AI-assisted diagnostic tools, not for mechanical power positioning systems. The device is a physical product that provides repositioning, not an AI model enhancing human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the BPPS is a mechanical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the BPPS's performance and safety is based on compliance with established international and national standards for wheelchairs and medical devices (e.g., ANSI/RESNA, ISO), physical testing results from mechanical, electrical, and biocompatibility evaluations, and demonstration of functional equivalence to a predicate device. This is a conformance-based assessment rather than interpretation of diagnostic data.
8. The sample size for the training set
This information is not applicable as this is a mechanical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a mechanical medical device, not an AI algorithm.
§ 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).