(82 days)
The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.
The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc.
The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position.
The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.
The Recline function causes the position of the occupant's back to change by 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 mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°.
The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.
The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.
The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.
Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.
The Modula Power Standing System (MPSS) aims to add standing (and other features) to a power wheelchair. The relevant information from the provided text has been extracted for your request. It should be noted that this is a 510(k) summary, and as such, detailed study information like sample sizes for test sets, the number and qualifications of experts, adjudication methods, and explicit effect sizes for human improvement with AI assistance are typically not part of such submissions, particularly for mechanical devices without AI components.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria (Performance Data) and Reported Device Performance
The acceptance criteria for the Modular Power Standing System (MPSS) are demonstrated by adherence to various ISO standards and by exhibiting similar technological characteristics to the predicate device (Levo C3) and a reference device (Motion Concepts Modular Power Positioning System). The 'Reported Device Performance' columns below reflect the characteristics of the Subject Device (MPSS) as provided in the comparison table.
| Acceptance Criteria Category | Specific Acceptance Criterion/Standard | Reported Device Performance (Subject Device - MPSS) | Comparison to Predicate/Reference |
|---|---|---|---|
| Biocompatibility Testing | ISO 10993 Part 5: Testing for in vitro cytotoxicity | Cytotoxicity testing performed | All body contact materials tested (Meshtex fabric, Startex fabric, Spacetex 4000U™ fabric, O-Vinyl fabric, Style 6499 Polyester fabric, Self-Skinning Skin PU Foam). |
| ISO 10993 Part 10: Tests for irritation and skin sensitization | Dermal Sensitization testing and/or Primary Skin Irritation testing performed | All body contact materials tested. | |
| Software Verification and Validation | FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software verification and validation conducted; documentation provided. | The software for this device is considered to have a "Moderate level of Concern." |
| Electrical Safety & EMC | ISO 7176-21: Requirements and Test Methods for Electromagnetic Compatibility of Electrically Powered Wheelchairs and Scooters. | Complies with ISO 7176-21. | Equivalent to predicate (A) and reference (B) devices. |
| Mechanical Testing | Relevant ISO 7176 standards for functional verification and device performance. | Testing established correct functionality. | Equivalent to predicate (A) and reference (B) devices for various mechanical aspects. |
| Weight Capacity | (Implicitly, comparable to predicate/reference withstanding max weight) | 250 lbs | Equivalent to reference device (B) with elevate. (Predicate device (A) has 310 lbs, reference (B) has 300 lbs (250lbs with elevate)). |
| Performance - Tilt | (Implicitly, functional range comparable to predicate/reference) | 45° | Functionally equivalent to predicate (A) (35°) and reference (B) (50°). |
| Performance - Recline | (Implicitly, functional range comparable to predicate/reference) | 178° | Functionally equivalent to predicate (A) (info not available) and reference (B) (168°). Note that slight increase in recline compared to (B) is required for effective stand option. |
| Performance - Elevation | (Implicitly, functional range comparable to predicate/reference) | 6.5" | Less than reference (B) which is 12". Offset by stand feature offering alternatives. |
| Other Mechanical Safety Features | Ensuring stability, drive lock-out, speed reduction, front caster lock to prevent tipping. | Wheelchair remains stable when fully tilted, reclined, elevated, standing. Speed is reduced, drive lock-out, tilt limit available, front caster lock. | Includes safety features equivalent to both predicate (A) and reference (B). |
| Where Used | Indoor and outdoor use. | Private residences, chronic-care facilities, indoors, outdoors. | Equivalent to predicate (A) and reference (B). |
| Power Stand-up Feature | Chest support, knee support. | Chest support and knee support standard. | Equivalent to predicate (A). |
| Motor Type/Voltage/Current/Power | (Implicitly, standard specifications) | Linear actuator, Gear reduction screw type; 24VDC; 4 Amps; 96W | Identical to reference (B). (Predicate (A) info not available) |
| Standards Met (Detailed list of ISO standards provided) | ISO 7176-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -13, -14, -15, -16, -21, -22, -30; EN 1021-1/-2; California Technical Bulletin 117-2013 | Compliance confirmed for listed ISO standards (FDA Recognition Number provided). Compliance for EN 1021-1/-2 and California Technical Bulletin 117-2013 implicitly met. | Equivalent to predicate (A) and reference (B) in meeting relevant standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of subject count for clinical testing. Instead, the performance data refers to various engineering and materials testing (biocompatibility, software, electrical, mechanical). For mechanical and electrical tests, it's typically performed on a limited number of device units rather than a "sample size" of users.
- Data Provenance: The testing appears to be internal verification and validation testing performed by Motion Concepts. There is no mention of country of origin for data or whether it was retrospective or prospective in the context of user studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The testing described is primarily engineering-based, not clinical trials requiring human expert ground truth for interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable/provided as the testing is not based on expert review or adjudication of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." The device is a mechanical system, not an AI or imaging device that would typically undergo such a study.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a mechanical device and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable, as this is a mechanical device; there is no "algorithm only" performance study in the context of AI or diagnostic interpretation. The device's performance is its direct mechanical functionality.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized international technical standards (ISO). For example, static stability (ISO 7176-1) is a directly measurable property against a standard, not subject to expert consensus or pathology. Biocompatibility is verified against ISO 10993 standards using laboratory tests.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical product; there is no "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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).