(30 days)
The intended use of the PDG Models Fuze T20 and T50 manual wheelchairs is to provide mobility to persons that may be limited to a seated position.
To provide mobility to persons limited to a seated position.
The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
The provided text describes a 510(k) premarket notification for the Fuze T20 and T50 Manual Wheelchairs. This type of regulatory submission is for medical devices, not artificial intelligence (AI) or software-as-a-medical-device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, study design, and ground truth establishment are not applicable.
The performance data for the Fuze T20 and T50 Manual Wheelchairs focuses on their compliance with established physical standards for wheelchairs.
Here's the breakdown based on the provided information, addressing the relevant sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 7176 - Determination of Static Stability as well as Static, Impact and Fatigue Strength | Designed to meet this standard. |
| ANSI/RESNA WC - 19 Motor Vehicle Transportation Crash Test | Designed to meet this standard. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not explicitly state the sample size (number of wheelchairs tested) or the provenance (country of origin, retrospective/prospective) of the data for these performance tests. It only states that the devices are "designed to meet" these standards, implying that testing was conducted or the design principles align with these standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable. The "ground truth" for a physical medical device like a wheelchair is compliance with established engineering and safety standards (ISO and ANSI/RESNA). These standards are developed by consensus of technical experts in the field, not through a process of individual expert adjudication of device performance in a clinical setting.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous data, often in the context of image analysis or medical expertise. For mechanical device testing against fixed standards, the results are typically objective (pass/fail for specific tests) and do not require expert adjudication in this manner.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- This question is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other medical tests, often comparing human readers with and without AI assistance. This is irrelevant for a manual wheelchair.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. A manual wheelchair does not involve an algorithm or AI component to be tested in a standalone manner.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is adherence to established international and national safety and performance standards for wheelchairs, specifically ISO 7176 and ANSI/RESNA WC-19.
8. The Sample Size for the Training Set
- This question is not applicable. Manual wheelchairs do not have "training sets" in the context of AI or machine learning. The design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons as #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).