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The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.

The Fecobionics Anorectal System (Fecobionics System) is a portable anorectal manometry device for use on patients requiring anorectal pressure studies and evaluation of defecatory function. The Fecobionics System consists of three main components: AR-100 Probe, DH-100 Data Hub, and Fecotracker App (installed on a provided PC-based laptop). The AR-100 Probe is a single-use, non-sterile disposable, battery-powered probe designed to be inserted manually into the rectum and wirelessly transmit data to the external Data Hub, which wirelessly sends the data to the PC with the Fecotracker App. The system provides clinicians with real-time manometric data and geometric mapping information in a single examination. The probe features a balloon designed to be filled with saline by means of a detachable fill tube and a Luer-Lock connection with a syringe. The inflation of the balloon allows the evaluation of sensation thresholds of the lower rectum and assesses and triggers Recto Anal Inhibitory Reflex (RAIR). To mimic the defecation process, the wireless probe is designed to be defecated as an untethered free distensible mass. In total, the Fecobionics System enables the evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The AR-100 Probe is 10cm long, and its interior bendable core is 10mm in diameter. When inflated with the allowed maximum saline inflation volume (100 mL), the balloon reaches a diameter of up to 5cm.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance beyond the successful completion of various tests. Instead, the acceptance criteria are largely implied by meeting the requirements of recognized standards and demonstrating "no difference," "comparable," or "high correlation" with the predicate device or expected results.

2. Sample Size Used for the Test Set and Data Provenance

The only explicitly mentioned test set with a sample size is the clinical study:

• Sample Size: 10 patients
• Data Provenance: The document states it was a "nonsignificant risk (NSR), observational, randomized clinical study." This implies a prospective study design. The country of origin of the data is not specified.

For the other performance tests (Biocompatibility, Electrical Safety, EMC, Software V&V, Functional Performance, Mechanical and Performance), the sample sizes are not explicitly stated. The provenance for these is "Preclinical and clinical tests" and "verification bench testing," implying laboratory or engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For the clinical study, it mentions "appropriately trained clinicians" are required to use the device, but it doesn't specify how many or their qualifications for establishing ground truth or evaluating the data. Given the comparative nature of the clinical study (comparing sensory measurements between the Fecobionics system and the predicate), it's likely the clinicians involved acted as evaluators, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. The device described is a diagnostic tool (anorectal manometry system) for measuring physiological parameters, not an AI-assisted interpretation or diagnostic aid for human readers. It provides data for clinicians to interpret, but it doesn't mention an AI component that assists human reading.
• Therefore, there is no effect size related to human readers improving with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The document implies the device provides raw data and measurements to clinicians ("The Fecobionics System provides clinicians with real-time manometric data and geometric mapping information in a single examination"), rather than producing an automated diagnosis or interpretation. Thus, the concept of "standalone algorithm performance" as typically applied to AI diagnostics is not directly applicable here. The device itself is a measurement system.
• The "functional performance accuracy verification" and "mechanical and performance tests" can be considered standalone performance tests of the device's measurement capabilities. The clinical study, while involving patients and comparison, still focuses on the device's ability to accurately measure sensory parameters.

7. The Type of Ground Truth Used

For the clinical study:

• The ground truth for sensory measurements was established by comparison to the predicate device. The study looked for "high correlation... between the sensation levels and the volume data with the two technologies," implying the predicate device served as the reference for acceptable sensory measurement.

For the other performance tests:

• Engineering specifications and recognized standards served as the ground truth. For example, IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility, and internal design requirements for mechanical and functional performance.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of an AI/ML algorithm. This indicates the device is not based on a machine learning model that requires a distinct training phase. The functional and clinical testing described are for verification and validation of a hardware and software system.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a training set or AI/ML algorithm, this question is not applicable.

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