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For use in converting collet terminal outputs of pacing devices equipped with "For use in converting concernment will connect to extension cables and terminals spaced "1:25" on connected pin connectors."

Models 4820 and 4825 Pacing Adapters

I apologize, but the provided text ({0}, {1}, {2}) does not contain information about the acceptance criteria or a study proving that a device meets such criteria.

The text is a Food and Drug Administration (FDA) 510(k) Premarket Notification letter for the PACE Medical, Inc. Models 4820 and 4825 Pacing Adapters. This letter:

• Identifies the device and its manufacturer.
• States that the device has been found substantially equivalent to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a device already on the market, based on the information provided by the manufacturer.
• Outlines the regulatory class and product code.
• Lists the "Indications for Use" which describe what the device is intended to be used for.
• Provides general information regarding compliance with FDA regulations.

There is no mention of:

• Specific acceptance criteria (e.g., performance thresholds for accuracy, sensitivity, specificity, etc.).
• A study design, methodology, or results demonstrating the device meets any particular performance metrics.
• Details about test sets, training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot provide the requested table or answer the points about study details based on the given input.

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