(233 days)
The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
The RGK Daily Range Wheelchairs are mechanical wheelchairs that include four wheels, an aluminum or titanium frame, and a black nylon upholstery that is flame resistant. Each wheelchair includes multiple components such as wheels, castors, sideguards, footplates and wheel locks.
The provided text describes the 510(k) premarket notification for RGK Daily Range Wheelchairs. As this is a submission for a mechanical wheelchair, it does not involve AI/ML technology or clinical studies for diagnostic accuracy. Therefore, many of the requested categories in your prompt are not applicable to this document.
However, I can extract the information relevant to the acceptance criteria and non-clinical testing performed to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "No FDA performance standards have been established for mechanical wheelchairs." However, the device was tested against international ISO and EN standards. The acceptance criteria would be successful completion of these tests.
| Test Parameter / Standard | Acceptance Criteria (Implied: Pass Standard) | Reported Device Performance |
|---|---|---|
| Static Stability (ISO 7176-1) | Device stable under specified conditions | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Effectiveness of Brakes (ISO 7176-3) | Brakes perform as required by standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Dimension, Mass, and Maneuvering Space (ISO 7176-5) | Conforms to specified dimensions, mass, and maneuvering space requirements | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Measurement of Seating and Wheel Measurements (ISO 7176-7) | Seating and wheel measurements conform to standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Requirements and Test Methods for Static Impact and Fatigue Strength (ISO 7176-8) | Withstands static impact and fatigue as per standard | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
| Wheeled mobility devices for use as seats in motor vehicles (ISO 7176-19) | Tiga model only meets requirements for use in motor vehicles | Not explicitly stated but implied successful completion to conclude substantial equivalence (for Tiga model). |
| Flammability (EN 1021-1 and EN 1021-2) | Upholstery meets flammability requirements | Not explicitly stated but implied successful completion to conclude substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for each test for the RGK Daily Range Wheelchairs. These are likely mechanical tests performed on a limited number of physical units, not a "data set" in the context of AI/ML. The tests are for the device itself. The provenance of these tests is not explicitly stated but assumed to be from the manufacturer (RGK Wheelchairs, Ltd. in the United Kingdom). The tests are prospective in the sense that they are performed on the device before market authorization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are non-clinical engineering and material tests, not diagnostic assessments requiring clinician experts to establish ground truth. The "ground truth" is determined by the physical properties and performance of the wheelchair against defined standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as it's not a clinical or AI performance study.
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 is a mechanical wheelchair, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical wheelchair, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests are the objective pass/fail criteria defined by the respective ISO and EN standards for mechanical wheelchairs. For example, a stability test has a specific physical outcome (falls or does not fall) when subjected to defined forces.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth for a training set." The design and manufacturing process for the wheelchair (including material testing) are described, but this is distinct from training an algorithm. The material specifications (like EN573-3, EN755-2, EN755-7, EN754-2, EN 10204) could be seen as baseline "truth" for material quality.
§ 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).