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The Duet-with Anorectal Manometry Suite is intended to measure and record the functioning of the patient's urinary tract and anorectal function*. The measurements comprise recording of pressure, volume, flow and EMG. The system includes transducers, devices, tubing, catheters and electrodes. * expanded indication for use due to the Anorectal Manometry Suite.

The Anorectal Manometry Suit is together with Duet/Duet MultiP intended to record a patients anorectal function compromising EMG and pressure recordings. The whole system includes transducers, devices, tubing, catheters and electrodes. The Duet / Duet MultiP is an apparatus capable of registration of pressure signals over a long time. The measurements and analysis have originally been developed for urodynamics tests, but since anorectal tests also are measuring pressure signals over a period of time, it is suitable to use the same technique for these types of tests, i.e. anorectal tests. The device is used in a dedicated clinical setup. The following sets of test types are predefined tests for measuring in the rectum: Sphincter Profile, Resting Pressure, Rectal Balloon test, Balloon Expulsion Test, Squeeze Test, Recto-Anal Inhibitory Test. The tests are operated just like the urodynamic tests. A license number is required to enable the software for the Anorectal Manometry Suite.

The provided 510(k) summary for the "Anorectal Manometry Suite for Duet / Duet MultiP" does not contain specific acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for a machine learning or AI-driven device.

This submission is for a software suite that expands the functionality of an existing urodynamics system (Duet/Duet MultiP) to include anorectal manometry. The core of the submission focuses on establishing substantial equivalence to a predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439) based on similar intended use, technology, and features, with a key difference being that the new device only records and calculates basic parameters (max, min, duration) rather than performing complex analysis or comparison to normal values.

Therefore, the following information cannot be extracted from the provided text in the context of typical AI/ML device evaluations:

1. Table of acceptance criteria and reported device performance: No such criteria or performance metrics are defined for the anorectal manometry suite in this document. The device's performance is not evaluated against quantitative thresholds.
2. Sample size used for the test set and data provenance: Not applicable. There's no test set described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device that humans would use to improve their reading.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a software suite that enables the recording and display of physiological signals, not an algorithmic diagnostic tool.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence and performance assessment:

• Assessment of non-clinical performance data for equivalence: "Verifications results shows that the enhanced system performs as its predicate system." This statement broadly indicates that the system's basic functions (recording pressure and EMG) were verified to operate correctly, similar to the predicate device. However, specific performance metrics or acceptance criteria are not detailed.
• Assessment of clinical performance data for equivalence: "Clinical evaluation not performed." This confirms that no clinical studies were conducted to evaluate the device's diagnostic accuracy or performance in a patient population. The equivalence is based on the technical similarity and intended use.
• Ground Truth for Equivalence: The primary "ground truth" for this submission is the established function and safety of the predicate device (Medtronic Synectics Anorectal Manomentry Analysis Module K972439). The new device is deemed substantially equivalent because its intended use, measurement capabilities (recording pressure and EMG), and the fundamental technology for capturing these signals are similar, and its lack of complex analysis a simpler, and thus presumably a safer, claim than the predicate.

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