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The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.

The mcompass device is a manometry system for the measurement of anorectal pressures. It is used in a clinical setting and consists of a non-sterile disposable catheter, a reusable RMD FOB, and software that resides on a tablet PC that collects, records and displays data. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC. Pressures are measured via four small, air-charged, radial balloons evenly spaced around the distal circumference of the catheter and a fifth larger balloon, positioned near the distal tip. The four small balloons measure radial contractile pressures of the anorectal canal while the most distal balloon is used to simulate a range of bowel fullness levels, in addition to measuring locational pressure.

The Medspira mcompass™ Anorectal Manometry System did not report specific acceptance criteria or detailed study results in the provided document. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial data with predefined acceptance criteria.

The information provided describes the device, its intended use, predicate devices, and the types of testing performed to ensure its functional and performance requirements.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
Specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's clinical performance are not explicitly stated in the provided document. The submission focuses on compliance with general functional, safety, and performance requirements through various standards.

Reported Device Performance:
The document states that "representative samples of the device underwent mechanical, electrical, and biocompatibility testing in accordance with the applicable industry standards." However, the quantitative results or specific performance metrics from these tests (e.g., exact pressure measurement accuracies, reliability figures) are not provided. The conclusion is simply that the device design "met its functional and performance requirements" and is "substantially equivalent" to predicate devices.

2. Sample Size for Test Set and Data Provenance

No information regarding a "test set" in the context of clinical performance or algorithm evaluation is provided. The functional and safety testing mentioned likely refers to laboratory-based engineering and safety tests rather than a clinical study test set for assessing diagnostic or prognostic performance. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable or not reported.

3. Number of Experts and Qualifications for Ground Truth

No information regarding a clinical study involving human experts to establish ground truth is provided. The device is a measurement system, and its "ground truth" would typically relate to the accuracy of its physical measurements against known standards, which is addressed by the functional and performance testing mentioned.

4. Adjudication Method

As no clinical study with human interpretation or expert-based ground truth is described, adjudication methods are not applicable or not reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. Standalone (Algorithm Only) Performance Study

The document does not describe an "algorithm only" performance study in the context of AI. The device includes software that "collects, records and displays data," implying a user interface for clinicians. The performance described relates to the accuracy of pressure measurements by the system as a whole.

7. Type of Ground Truth Used

For the functional and performance testing mentioned:

• Physical standards/calibrations: The "ground truth" for pressure measurements would be established through calibrated pressure sources and other physical reference standards used during the mechanical and electrical testing.
• Industry standards: Biocompatibility testing relies on established biological evaluation standards (ISO 10993 series).

8. Sample Size for Training Set

The document does not describe the use of machine learning algorithms requiring a "training set" in the context of AI. The software primarily handles data collection, recording, and display. Therefore, sample size for a training set is not applicable or not reported.

9. How Ground Truth for Training Set Was Established

As no training set for a machine learning algorithm is mentioned, this information is not applicable or not reported.

In summary: The provided document is a 510(k) summary for a medical device that measures anorectal pressures. It demonstrates substantial equivalence through compliance with safety and performance standards rather than presenting detailed clinical performance data with specific acceptance criteria, clinical study designs, or AI-specific evaluation metrics. The "study" referenced refers to laboratory-based functional, electrical, and biocompatibility testing against recognized industry standards.

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