(172 days)
Quickie powered wheelchairs empower physically challenged persons by providing a means of mobility. This included conditions in all ages such as: Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic Tetaplegic (Quadraplegic) Spina Bifida Head Injury or Trauma Muscular Dystrophy Multiple Scierosis Polio Geriatric Conditions And other immobilizing or debilitating conditions
Quickie P90 Power Wheelchairs consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:
The provided document describes a 510(k) submission for the Quickie P90 Power Wheelchair Series. It is important to note that this document is for a medical device (a power wheelchair), not an AI/ML-driven diagnostic or prognostic device. Therefore, many of the typical acceptance criteria and study methods associated with AI, such as standalone performance, MRMC studies, ground truth establishment by experts, and sample sizes for training/test sets in the context of machine learning, are not applicable to this type of device submission.
The document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a power wheelchair) and the context of a 510(k) submission, the "acceptance criteria" are primarily established by compliance with recognized engineering and safety standards, and the "performance" is demonstrated by passing tests defined by these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Successful Testing) |
|---|---|
| ISO 7176 Wheelchair Standards: | Tested to both ISO 7176 |
| - Static Stability | Successful |
| - Dynamic Stability | Successful |
| - Effectiveness of Brakes | Successful |
| - Energy Consumption | Successful |
| - Overall Dimensions | Successful |
| - Maximum Speed acceleration and retardation | Successful |
| - Static Impact | Successful |
| - Fatigue Strength | Successful |
| - Climatic Test | Successful |
| - Obstacle Climbing Ability | Successful |
| - Testing of Power and Control System | Successful |
| ANSI/RESNA Wheelchair Standards: | Tested to both ANSI/RESNA Wheelchair Standards |
| EMC Testing: | Tested to: |
- Proposed Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94
- ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical trials or data for an AI algorithm. For a physical product like a wheelchair, testing typically involves one or more prototypes of the device model itself, not a "sample size" of patient data. The standards define how those prototypes are tested.
- Data Provenance: Not applicable in the AI/ML sense. The "data" here comes from direct physical testing of the device prototypes in a laboratory or controlled environment, against established engineering standards. There is no patient data or retrospective/prospective data collection described for the testing of substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like a wheelchair is established by its ability to meet objective, quantifiable measurements and performance targets defined by established engineering and safety standards (e.g., brake effectiveness, stability angles, fatigue cycles). These standards are developed by consensus of engineers and safety experts over time, but there isn't a specific set of experts establishing ground truth for this device's test set in the way one would for diagnostic imaging.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Testing against engineering standards is typically objective; a test either passes or fails according to predefined criteria. There's no subjective interpretation requiring adjudication of results in the way an AI diagnostic result might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a power wheelchair.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a standalone performance study done? No. This concept applies to AI algorithms that can operate independently of human intervention for tasks like detection or classification. A power wheelchair is a physical product directly used by a human.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's acceptance is adherence to established engineering and safety standards. These standards define objective, measurable performance characteristics (e.g., maximum speed, stability angles, brake effectiveness, fatigue resistance, EMC compliance).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
Summary for the Quickie P90 Power Wheelchair Series:
This device's acceptance criteria are based on its compliance with international (ISO 7176) and national (ANSI/RESNA) wheelchair safety and performance standards. The "study" involves subjecting prototypes of the wheelchair to a battery of tests specified by these standards, covering aspects like stability, braking, durability, and electromagnetic compatibility. The demonstration of passing these tests constitutes the evidence that the device meets its performance and safety requirements for market clearance under the 510(k) pathway for substantial equivalence. The submission does not involve clinical trials, AI algorithm performance, or human reader studies.
§ 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).