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Cutting and removal of bone and acrylic bone cement in orthopedic applications.

The Ultra-Drive® 3 consists of a control console, a footswitch, a handpiece with associated cables and connecting tubing, a variety of tool tips and other associated accessories. The system converts standard electrical power (120/240V) into electrical energy at 40 kHz. The high frequency electrical energy produced by the generator is sent through a cable to a transducer that changes the electrical energy into longitudinal 40kHz vibrations. The ultrasonic vibrations are then transmitted to the tool tip that is supplied to the bone or bone cement which is to be removed.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is a 510(k) premarket notification summary and an FDA clearance letter for the Ultra-Drive 3 ultrasonic surgical instrument.

Here's what the document does state and why it doesn't align with the request:

• No Acceptance Criteria or Performance Study: The "Clinical and Non-Clinical Testing" section explicitly states "None provided." This indicates that Biomet did not submit performance data with specific acceptance criteria to demonstrate the device's safety and effectiveness.
• Substantial Equivalence: The FDA clearance is based on "substantial equivalence" to a legally marketed predicate device (System 10, Model 100 Surgical System for Orthopedic Use, K900003). This means the FDA determined the Ultra-Drive 3 is as safe and effective as the predicate device, largely due to similar technology, materials, and intended use, rather than requiring new performance studies against predefined acceptance criteria for this specific device.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and a study to prove they are met because this information is not present in the provided text.

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