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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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For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field.

Model 4255 or Model 4260 Disposable Extension Cables

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Model 4255 or Model 4260 Disposable Extension Cables." It primarily states that the device is substantially equivalent to a predicate device and can be marketed. It does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or specific performance metrics.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device