(202 days)
The Element pediatric wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Element Pediatric Wheelchair is designed for children who are limited to a seated position and require mobility and positioning assistance. It is intended for individuals less than 21 years old, who weigh less than 185 pounds.
The Element Pediatric Wheelchair consists of a frame and wheels (part number 3101-0000). The frame is powder-coated aluminum and the non-inflatable wheels are polyurethane plastic. The seat back, seat bottom, restraints and armrests are covered in flame retardant nylon fabric. The footrests are powder-coated aluminum. The seat back, seat bottom, armrests, footrests, and restraints are specified by a professional wheelchair fitter. Parameters such as seat width (18-28") and depth (10-22") are changeable over the course of use. This adds adjustability to the wheelchair to meet the needs of growth, postural changes, and level of disability.
Parameters adjustable by manufacturer or distributor include: seat width, seat depth, seat to floor height, wheel size, wheel base distance. Parameters adjustable by user include: back cane height, tilt of chair, foot rest height, and seat back angle (recline).
The Element has a "Transit Option" that is compliant with RESNA WC-19. The Element is foldable for storage or transport.
The Element was designed for firm and smooth surfaces, both indoors and outdoors. It is intended for surfaces with less than 5° slope. A back cane hand grip is provided for an attendant to push.
Principle of Operation: The Leggero Element Pediatric Wheelchair provides a stable seat and wheel chassis designed to provide mobility to persons restricted to a sitting position.
The provided text describes a 510(k) summary for the Element Pediatric Wheelchair, comparing it to a predicate device. The information requested pertains to the acceptance criteria and study data for a software medical device. This document, however, describes a mechanical wheelchair.
Therefore, most of the requested information (like multi-reader multi-case studies, standalone algorithm performance, training/test set sample sizes, ground truth establishment, expert qualifications, adjudication methods) is not applicable to this device.
However, I can extract the acceptance criteria and performance data that are present for this mechanical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Determination of static stability | PASS (per ANSI/RESNA Section 1) | PASS |
| Static Impact and fatigue strength | PASS (per ANSI/RESNA Section 8) | PASS |
| Determination of Dimensions, mass, turning space | PASS (per ANSI/RESNA Section 5) | PASS |
| Determination of safety when used as seat in motor vehicle | PASS (per ISO 7176-19) | PASS |
| Biocompatibility of contact surfaces | PASS (per ISO 10993-1) | PASS |
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided in the document for the mechanical tests. The document refers to testing the "Element" and "Zippie" without specifying the number of units tested. This data is not clinical data or software performance 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):
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic or prognostic task. The tests are engineering/performance-based, relying on established standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. See point 3.
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:
Not applicable. This device is a mechanical wheelchair, not an AI software.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a mechanical wheelchair, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" (or more appropriately, the standard for success) for this device's performance testing is adherence to established international and national standards for wheelchairs, specifically:
- ANSI/RESNA Section 1: Determination of static stability.
- ANSI/RESNA Section 5: Determination of dimensions, mass, and maneuvering space.
- ANSI/RESNA Section 7: Method of measurement of seating and wheel dimensions.
- ANSI/RESNA Section 8: Requirements and test methods for static, impact and fatigue strengths.
- ANSI/RESNA Section 11: Test dummies.
- ANSI/RESNA Section 13: Determination of coefficient of friction of test surfaces.
- ANSI/RESNA Section 22: Set-up procedures.
- ANSI/RESNA Section 26: Vocabulary.
- RESNA WC-2 Section 3: Determination of the effectiveness of brakes.
- RESNA WC-1 Section 15: Requirements for information disclosure, documentation and labeling.
- ISO 7176-19 Wheeled mobility devices for use as seats in motor vehicles.
- ISO 7176-16 Resistance to ignition of postural support devices.
- ISO 10993-1 (4th Edition 2009) guided the biocompatibility assessments of the patient and operator contact surfaces.
8. The sample size for the training set:
Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).