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510(k) Data Aggregation
(112 days)
The URok Rocking Wheelchair is intended to provide mobility to persons limited to a sitting position while the rocking mechanism is locked in an upright position.
The wheelchair is intended to redistribute pressures exerted on the buttocks and lower back when rocking or tilted at an angle.
The wheelchair is intended to provide comfort adjustment while rocking or tilted at an angle.
The AMG Medical Inc. URok Rocking Wheelchair is a manually operated, attendant or user propelled, mechanical rocking wheelchair. The device is a lightweight wheelchair, suitable for both indoor and outdoor use.
The device consists of an aluminum frame, one size of rear wheel, and smaller front pivoting casters for steering and turning. The frame is constructed from aluminum tubing that is TIG-welded. This device is a rigid, non-folding type of wheelchair that incorporates a padded, sling style seat. The upholstery meets the requirements of ISO 7176-16, flammability standards.
The AMG URok Rocking Wheelchair includes a rocking feature which permits dynamic pressure management of the seating pressure upon the buttocks. The rocking feature is realized by the placement of two vertically positioned fibrogless Ieaf springs, which are connected to the seat and frame, under the seat's centre of gravity. The balance of the seat upon the springs is precise enough so that the rocking motion may be initiated by the user simply by gently moving the head backward and forward. Safety features such as anti tippers and rock arrestors limit the arc of the rocking motion. The rocking feature can be "locked out" by an attendant so that the device can be used as a wheelchair with no rocking motion.
The AMG URok wheelchair also has a "tilts in space" feature. The rocking mcchanism can be locked in multiple positions to provide "tilt in space" that permits receing meemainst backwards thereby allowing gravity to hold them in position. This is used to help in positioning, comfort, or head control. The tilt in space is initiated by the attendant pushing down on the push handles to tilt the scat and back and locking out the rocking action when the desired angle of tilt is reached.
The rocking feature is released or is locked out by two cable controlled pins that insert into holes within two vertically mounted metal plates located under the seat support tubes. The cables are controlled using bicycle brake type levers in onto bed on the rear push tube or handle.
The Urok Rocking Wheelchair by AMG Medical Inc. had the following acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets ANSI/RESNA WC series wheelchair requirements | The AMG URok Rocking Wheelchair meets the performance requirements specified in the ANSI/RESNA WC series of wheelchair requirements. |
| Redistributes pressure while rocking | Pressure redistribution obtained while rocking was observed and recorded using adult human volunteers. |
| Provides comfort adjustment while rocking or tilted | (Implied by the intended use; no specific performance metric reported in this summary for comfort beyond observation.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: "adult human volunteers" (specific number not provided).
- Data Provenance: Not explicitly stated, but the submission is from a Canadian company, so the testing likely occurred in Canada or the US. It appears to be prospective data collection for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device concerned physical performance and pressure redistribution, not an expert-derived clinical diagnosis or assessment. The pressure redistribution was "observed and recorded," implying measurement rather than expert consensus on a subjective outcome.
4. Adjudication Method for the Test Set:
Not applicable. The performance data involved physical measurements (pressure redistribution) and adherence to engineering standards (ANSI/RESNA), not a subjective assessment requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No. This type of study, common for AI-powered diagnostic tools, was not relevant nor performed for this medical device (a mechanical wheelchair).
6. Standalone Performance Study:
Yes. The mentioned performance data for pressure redistribution and compliance with ANSI/RESNA standards reflect the standalone performance of the device itself.
7. Type of Ground Truth Used:
- Engineering Standards: Conformance to the ANSI/RESNA WC series of wheelchair requirements.
- Direct Measurement/Observation: Pressure redistribution was "observed and recorded" using a pressure recording mat on adult human volunteers.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical wheelchair, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a mechanical device.
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