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The intended use of PERCUGUARD ™ is to prevent accidental needle stick and/or sharps injuries to healthcare workers on the fingers and thumbs exposed lo injuries.

It is a protective finger guard accessory to the examination glove. It is used on the finger and/or the thumb of the non-dominant hand usually used to retract, stabilize. or isolate in preparation for an injection procedure. Il may be inverted and used to prevent accidental needle sticks while suluring. It can be used on the dominant hand (device inverted) when isolating, retracting, stabilizing, or palpating tissue where sharp bone or wires are present in order to protect the palm side of the fingers or thumbs

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets them. The document is a 510(k) clearance letter from the FDA for a device named "Percuguard™," indicating that it has been found substantially equivalent to a predicate device.

The letter discusses:

• The review of the 510(k) notification.
• The determination of substantial equivalence.
• Regulatory classifications and general controls.
• Contact information for various FDA offices.
• The product's intended use.

However, there is no mention of specific acceptance criteria, performance data, study design, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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