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THE INTENDED OEVICE is TO PROVIDE THE ITS INTENDED ASE THE USER. 70 SAME AS THE PREDICATE TTHE CHARCT BRIS TIC FEDTUCES AWO BOTH DEVICES ARE 11-1 TTFE SAME BOTH HAUE A RECL THEY 5 TI> BLE SACH MULTIPLE SEDTING Pos 17.70

The Suspension Seating of the World Class Wheeled Chair marketed by Suiter Medical is a design that gives the chair user incredible comfort with a multitude of positions for seat, back, leg, and arm supportsindependently or in unison. From the suspension piyot points, located just below the arm rests, the chair user can rock, tilt, or recline while maintaining their center of weight forward of the rear wheels. This design serves the need for movement to avoid being drawn into an ever-tightening contracted ball.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided document. The document describes a "World Class Wheeled Chair" which is a mechanical wheelchair, and the information primarily focuses on a 510(k) submission for substantial equivalence to a predicate device.

The provided text does not contain any information regarding:

• Acceptance criteria: There are no specific performance metrics or thresholds mentioned for the device.
• Study design or results: The document is a 510(k) summary and an FDA clearance letter, which does not typically include detailed study protocols, results, statistical analysis, or performance data beyond the claim of substantial equivalence.
• Sample size for test or training sets: No study data is presented, so no sample sizes are available.
• Data provenance, expert qualifications, or ground truth establishment: These are all elements of a clinical or performance study, which is not detailed in this submission.
• MRMC comparative effectiveness study or standalone performance: These types of studies are not discussed.

The document states: "The World Class Wheeled Chair marketed by Suiter Medical is a design that gives the chair user incredible comfort with a multitude of positions for seat, back, leg, and arm supports independently or in unison. From the suspension pivot points, located just below the arm rests, the chair user can rock, tilt, or recline while maintaining their center of weight forward of the rear wheels. This design serves the need for movement to avoid being drawn into an ever-tightening contracted ball."
And "The intended use of the device is to provide mobility to the user. Its intended use is the same as the predicate device. Features and characteristics of both devices are the same in that they both have a reclining back, an adjustable back, provide multiple seating positions, both tilt-in-place."

These statements describe the device's features and intended use, and claim it has the "same" features and intended use as the predicate device, leading to a finding of "substantial equivalence." However, substantial equivalence itself is the regulatory pathway, not a detailed performance study with quantifiable acceptance criteria.

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