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The High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.

The device is used in conjunction with a manometry system. Studies performed with this system require a skilled interpretation by a physician to aid in making a diagnosis of gastrointestinal motility disorders.

The device is indicated for use on adult populations only.

The Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a flexible polyurethane tube with a series of pressure and impedance sensors evenly spaced along the distal section of the device, an atraumatic tip, and a proximal end electrical connector/handle with an internal signal processor.

This probe is used in conjunction with the Sandhill Scientific Gastrointestinal Motility System (K012232). This motility system consists of a Central Unit, an Interface Cable. Software, and a system cart to organize and hold the system components and computer. The Central Unit receives and conditions electrical signals from the probe to display manometric information through the software. The predicate probe from Unisensor currently uses this same Sandhill Scientific Gastrointestinal Motility (Manometry) system. The overall system provides information to trained clinicians as an aid in documenting and diagnosing digestive motility disorders. The probe is the primary patient measurement device during a gastrointestinal tract motility study.

The HRiM Probe pressure transducers produce electrical signals that vary in direct proportion to the maqnitude of the applied pressure from muscular contractions (peristalsis) within the qastrointestinal tract. The pressure sensor elements are semiconductor strain gauge devices that convert the applied external forces to proportional electrical signals. These pressure sensors each have a unique digital address controlled by the internal signal processor in the proximal end connector/handle of the probe. The probe uses a time multiplexor that generates the address of the pressure sensor to activate, sends that request to the sensor, and then reads the results. Pressure during a motility study is used to assess GI tract clearance via peristalsis.

In addition to pressure sensors for monitoring peristalsis, the probe also contains impedance sensors to provide data to assess bolus transit dynamics. The impedance sensor data is used to detect the direction and transition time of the fluid or food bolus in the GI tract by making use of their natural conductivity. These sensors are made from stainless steel and are designed to show relative impedance changes between GI tract baseline impedance and the impedance seen when a fluid/bolus passes the sensors.

Using pressure (manometry) and impedance together clarifies which patients with manometric abnormalities may have GI tract function disorders.

The provided text describes the non-clinical performance data for the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe to support its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the format requested. However, I can extract the reported performance and the type of studies conducted.

Here is a summary of the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a tabular format with corresponding reported performance for specific metrics. Instead, it describes various bench tests performed to demonstrate equivalence to the predicate device and compliance with relevant standards.

Here's an interpretation of the performance demonstrated through the testing:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "samples from initial production lots" were used for testing (Page 7). However, it does not specify the exact sample size (number of probes) for each test. All testing appears to be prospective bench testing conducted by Diversatek Healthcare. There is no information provided about the country of origin of the data beyond "Diversatek Healthcare performed bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies described are non-clinical bench tests comparing the device against a predicate and established engineering standards, rather than clinical studies requiring expert interpretation of results for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the studies described are non-clinical bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was deemed unnecessary to support substantial equivalence. The nonclinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device." (Page 8). This device is a measurement probe, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable in the context of standalone algorithm performance. The device is a "High Resolution Impedance Manometry (HRiM) Probe" designed to obtain physiological data, not an algorithm in the traditional sense of AI. Its "standalone" performance is assessed through its ability to accurately measure pressure and impedance, which was demonstrated through the bench testing described. The probe does contain embedded firmware (software) which was verified and validated (Section 9).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance evaluation was based on:

• Predicate device's performance: The Diversatek Healthcare HRiM Probe's function and performance were compared directly against the Unisensor predicate device for parameters like sensor spacing, span, sensitivity, etc.
• Established engineering standards: Compliance with standards like ISO 10993-1 (biocompatibility), IEC 60601-1-2 and IEC 60601-1 (electrical safety and EMC), ASTM F1980-16 (accelerated aging), and BS EN 1618 (joint strength) served as the "ground truth" for those specific tests.
• Internal specifications and design objectives: The device was designed to withstand certain cycles of use and aging, and verification confirmed it met these objectives.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable. The device does not utilize a "training set" for an AI model.

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