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THE SMALL HIGH SPEED DRICE SYSTEM IS INTENDED FOR RAPID DISSEETTON OF BONE, BOPLASTICS AND BIOMATERIALS DURING NEUROSURGICAL, ENT AND MAXILLOFACIAL SURGICAL PROCEDURES

SMALL MIGH SPEED MOTOR DRILL SYSTEMS

This document is a 510(k) premarket notification decision letter from the FDA for a "Small High Speed Motor Drill System." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a regulatory approval document and does not detail the technical performance studies that would have been submitted as part of the 510(k) application. To answer your questions, one would need to access the actual 510(k) submission documentation, which is not provided here.

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This is intended to enclose medical devices that are to be sterilized in a health care facility. The tray is intended to allow steam to penetrate to the enclosed medical devices.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Dental Sterilization Tray/Cassette". This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily addresses the regulatory classification and premarket notification status of the device, confirming its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

Ask a specific question about this device