(9 days)
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages suc as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic
Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy_
Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
A wheelchair with Bus Transport Option may be used for motor vehicle transportatio with the use of wheelchair tie down and occupant restraint system (WTORS) that me the requirements of SAE J2249
Zippie GS wheelchairs are light weight, low maintenance, manual chairs, which are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user.
The key change covered by this submission is the addition of optional growing solid seat and growing adjustable back. Individuals who use these wheelchairs benefit from the use of different seat cushions and back shapes as required by their individual postures and level of disability.
The addition of an optional growing solid seat facilitates the use of various cushions. The seat has been designed to offer a low cost support for these cushions. By being able to "grow" with the frame as it is adjusted in width and depth to accommodate change in the client's posture, dimensions or condition, the cost of these changes is reduced.
The addition of an optional growing adjustable back upholstery provides users the ability to adjust the contours of the upholstery by adjusting the length of individual straps at various contact points on the trunk. The back is also adjustable in height to match the height of various clients and their need for various degrees of posterior trunk support. The individuals straps also allow for adjustment of the depth of contour or "hammocking" of the back. This allows the client to adjust for lateral support of the trunk. The back has been designed to offer a low cost means for the adjustment of the aforementioned supporting shapes. Additionally by being able to "grow" with the frame as it is adjusted in width to accommodate change in the client's width, the cost of these changes is reduced.
When couple with the adjustment of the following performance factors the users function and comfort can be enhanced.
Here's an analysis of the provided text regarding the Zippie GS wheelchair's acceptance criteria and studies:
Important Note: The provided document is a 510(k) summary for a medical device (a wheelchair). Unlike typical AI/software device submissions, this document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific performance metrics through detailed clinical trials. Therefore, many of the requested fields (like sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable (N/A) in this context, as the regulatory pathway for this type of device does not typically require that level of performance data. The "acceptance criteria" here relate more to meeting established safety and performance standards for wheelchairs.
Acceptance Criteria and Device Performance (Zippie GS Wheelchair)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Factors) | Reported Device Performance/Compliance |
|---|---|
| Camber adjustments range | "Camber adjustments range from 0 to 6 degrees." (This is a feature/capability, not a performance metric to be 'met' beyond being available) |
| Wheel position (Rear wheel setback for stability) | "Rear wheels are set back to increase the wheelchair base. This improves stability." (A design feature for stability) |
| Wheel Base or Track Width adjustment range | "Currently adjustable over a 4-inch range, a wider wheel base increases stability." (A feature/capability for adjustment) |
| Caster height adjustment range | "Caster fork allows adjustments to be made ranging from +/-1 inch." (A feature/capability for adjustment) |
| Back Rest Angle adjustment range | "Adjustable from 78 degrees to 120 degrees." (A feature/capability for adjustment) |
| Seat Angle or Squeeze adjustment range | "Adjustable squeeze from 0 - 2 inches." (A feature/capability for adjustment) |
| Center of Gravity adjustment (via axle position, seat angle, seat depth) | "This adjustment is made by the rider to his personal sense of balance, and reactivity." (A feature allowing user adjustment, not a specific performance value to be met by a single study) |
| **Determination of Static Stability (ISO7176 | ANSVRESNA)** |
| **Overall Dimensions, Mass, and Turning Space (ISO7176 | ANSVRESNA)** |
| **Seating Dimensions (ISO7176 | ANSVRESNA)** |
| **Static Impact and Fatigue Strength (ISO7176 | ANSVRESNA)** |
| Safety (Analysis of complaints & literature search) | "Analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share." (This indicates the device is not expected to be less safe than comparators, as the design changes do not introduce new safety issues.) |
| Efficacy (Mechanical reclining wheelchairs) | "Articles are being provided on the use and efficacy of mechanical reclining wheelchairs." (References existing literature for the general efficacy of the type of chair, not device-specific efficacy testing.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated or applicable for a 510(k) submission for this type of device. The "testing" refers to adherence to established general wheelchair standards and internal design verification, not a clinical trial with a defined patient test set.
- Data Provenance: The standard tests (ISO7176 and ANSVRESNA) are likely performed in a controlled laboratory setting by the manufacturer or accredited testing facilities. The complaint analysis is retrospective, drawing from existing market data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- N/A. For this type of device and regulatory pathway, there is no "ground truth" derived from expert consensus on features like the presence of a disease or lesion. The testing involves engineering and mechanical performance against established standards.
4. Adjudication Method for the Test Set
- N/A. As there isn't a "test set" in the sense of patient cases requiring adjudication, this concept does not apply. The testing is against objective engineering standards.
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
- N/A. This device is a manual wheelchair, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- Engineering Standards / Objective Measurements: The "ground truth" (or basis for acceptance) is compliance with internationally recognized wheelchair safety and performance standards (ISO7176 and ANSVRESNA), along with internal design specifications meeting functional requirements. The "Pass" results confirm the device meets these objective standards.
8. The Sample Size for the Training Set
- N/A. This device does not use machine learning or AI, so there is no training set.
9. How the Ground Truth for the Training Set was Established
- N/A. As there is no training set, this is not applicable.
§ 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).