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The Remington Medical Disposable Surgical Extension Cable is an electrical excesson cable. used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e. analyzer). The alligator clips are color coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).

The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pace makers, pace analyzers, and patient pacing leads currently on the market.

The cable is a sterile, disposable device.

The Remington Medical Disposable Surgical Extension Cable is an electrical excesson cable. used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e. analyzer). The alligator clips are color coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).

The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pace makers, pace analyzers, and patient pacing leads currently on the market.

The cable is a sterile, disposable device.

Here's the analysis of the provided text regarding acceptance criteria and a study.

Unfortunately, the provided text does not contain any information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Safe Connect Surgical Cable." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

While the letter mentions the device's intended use and some specifications (like carrying a maximum electrical load of 300 volts), it does not detail any specific performance metrics, clinical studies, or acceptance criteria that were used to demonstrate its safety or effectiveness beyond substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions you've asked based on this input. The information necessary to describe acceptance criteria and a study (including sample sizes, ground truth establishment, expert qualifications, etc.) is simply not present in this document.

To answer your request, I would need a document that describes the results of a study (clinical or pre-clinical) that was performed to evaluate the performance of the device against predefined criteria.

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