(104 days)
The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.
This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to Market the P.R.O. CG® Manual Wheelchair. The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.
This document is a 510(k) premarket notification for the P.R.O. CG® Manual Wheelchair. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to determine the performance against specific acceptance criteria for a novel AI/medical device.
Therefore, the requested information regarding acceptance criteria, study details for proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the provided text.
The document discusses the substantial equivalence of the P.R.O. CG® Manual Wheelchair to a predicate device (Manual Rigid Mobility Wheelchair K080270). The performance data presented refers to non-clinical laboratory testing to ensure the new device meets established safety and performance standards for manual wheelchairs, which are different from acceptance criteria for AI-powered devices.
Here's an overview of what the document does provide regarding "performance," which is related to substantial equivalence for a medical device:
1. A table of acceptance criteria and the reported device performance:
This document does not present "acceptance criteria" in the way one would for an AI-enabled device (e.g., minimum sensitivity/specificity/AUC). Instead, it lists the ISO and ANSI/RESNA standards against which the device was tested to demonstrate safety and performance for a manual wheelchair. The reported device performance is that the testing "demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device." This implies that the wheelchair met the requirements of each standard.
| Acceptance Criteria (Standards Tested) | Reported Device Performance |
|---|---|
| ISO International Standard 7176-1: Determination of Static Stability | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-3: Determination of Effectiveness of Brakes | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-5: Determination of Dimensions, Mass and Maneuvering Space | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-7: Measurement of Seating and Wheel Dimensions | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-11: Test dummies | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-13: Determination of Coefficient of Friction of Test Surfaces | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-15: Requirements for Information Disclosure, Documentation and Labeling | Demonstrated substantial equivalence to predicate device |
| ISO International Standard 7176-19: Wheeled Mobility Device for Use in Motor Vehicles Annex A. C and D | Demonstrated substantial equivalence to predicate device |
| ANSI/RESNA WC-4: 2012, Section 19: Wheelchairs Used as Seats in Motor Vehicles Annex A, B, C and E | Demonstrated substantial equivalence to predicate device |
| CAL117:2013, Section 1: Flammability Testing | Demonstrated substantial equivalence to predicate device |
Missing Information (Not Applicable to this Document Type):
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical wheelchair testing, not a dataset of patient information.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" for a manual wheelchair is whether it meets engineering standards for safety and structural integrity.
- The sample size for the training set: Not applicable. There is no AI model or training set involved.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes a traditional medical device (manual wheelchair) submission, not an AI or diagnostic device that would have the requested acceptance criteria and study details.
§ 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).