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The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.

The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.

The provided document is a 510(k) submission for the Polygram 98 pH Testing System (incl. bile). It describes a device that measures pH and bile reflux in the gastrointestinal tract. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical performance data with acceptance criteria in the way a novel AI/ML device might.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance from a clinical trial or a standalone algorithm assessment. Instead, it focuses on demonstrating equivalence to a predicate device. The modifications primarily involve the addition of bile measurement capabilities and software updates.

The document lists "Calculated parameters" for both pH and Bile analysis, which are effectively the output of the system. These include various measurements like:

• Maximum, Minimum
• Duration of period
• Number of (acid/bile) refluxes
• Number of long (acid/bile) refluxes
• Longest (acid/bile) reflux
• Total time (pH below 4 / bile above 0.14)
• Fraction time (pH below 4 / bile above 0.14)
• Symptom index
• Symptom Association Probability

For pH, it also lists "Scoring Normals" like DeMeester & Johnson, Bolx-Ochoa, and Infant normals. For Bile analysis, it explicitly states "No scoring system exists for Bile analysis." This indicates that while the system measures bile, there aren't established clinical thresholds or scoring systems for it, unlike pH.

The primary "acceptance criterion" implicit in a 510(k) submission is substantial equivalence to the predicate device. The document states:

• "Verifications results show that the enhanced system performs as its predicate system." (referring to non-clinical performance data)
• "This new system does not raise any new safety or performance issues."

Therefore, a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) is not provided because the submission's focus is on demonstrating that the new features (bile measurement and software) do not negatively impact the safety or effectiveness of the previously cleared pH system and that the bile measurement functionality is appropriately described and safe.

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

The document explicitly states: "Clinical trials have not been performed." This means there is no test set in the sense of patient data used to evaluate the clinical performance of the device or its new features. The evaluation relies on non-clinical verification and a comparison of technical features to the predicate device.

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

Since no clinical trials were performed and no specific test set was evaluated for clinical performance, there were no experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

Not applicable. This device is a measurement system, not an AI-assisted diagnostic tool for human readers, and no MRMC study was performed.

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

The device is a "system" (Bilitec 2000 hardware + Polygram 98 software) that measures physiological parameters. It does not contain an "algorithm" in the AI/ML sense that would have a standalone performance evaluated for accuracy, sensitivity, specificity, etc. The software analyzes and displays the data collected by the hardware. The documentation states "Verifications results show that the enhanced system performs as its predicate system," referring to non-clinical technical verifications.

7. The Type of Ground Truth Used

Given that clinical trials were not performed, there's no ground truth established from pathology, expert consensus, or outcomes data for the new components of the device. The "ground truth" for the predicate device's pH measurements would have been established historically but is not detailed here. For the added bile measurement, the system reports absorbance units, and the document notes that "No scoring system exists for Bile analysis," implying that clinical "ground truth" thresholds or diagnostic criteria for bile reflux were not established or leveraged at the time of this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable, as there is no training set.

Summary regarding this specific document:

This 510(k) submission is for a device that is primarily an updated version of an existing physiological measurement system, adding the capability to measure bile reflux. The regulatory pathway chosen (510(k)) primarily requires demonstrating substantial equivalence to a predicate device, and for this submission, no clinical trials were conducted to assess the performance of the new features against specific clinical acceptance criteria or ground truth. The assessment relies on non-clinical verification that the "enhanced system performs as its predicate system" and that it "does not raise any new safety or performance issues." The lack of specific performance metrics, clinical test sets, or expert evaluations is typical for 510(k) submissions of this nature, especially when the changes are characterized as modifications to an existing device rather than a fundamentally new technology requiring de novo clinical validation.

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