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The Ano-Rectal Manometry (ARM) Option to Laborie's PC-based urodynamic systems is intended to be used in quantifying ano-rectal pressures. Using the same transducers as for urodynamics but with a different measuring range, the ARM Option can be used for performing standard ano-rectal manometric measurements.

Ano-rectal Manometry Option Device, Model UDS-ARM

The provided document is a 510(k) clearance letter from the FDA for a device called "Ano-rectal Manometry Option Device, Model UDS-ARM" and its Indications for Use statement. This document confirms the device's substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter is a regulatory approval document and focuses on stating that the device is substantially equivalent to a pre-amendments device, allowing it to be marketed. It does not include the detailed technical or clinical study data that would typically contain the information requested in your prompt.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, one would need access to the actual 510(k) submission (K963064) which would contain the performance data and methodology used to demonstrate substantial equivalence.

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