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The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

The Bravo pH Monitoring System™ and Accessories is an ambulatory esophageal pH testing device. The Bravo system is a simple, minimally invasive outpatient procedure that involves the placement of a pH telemetry Capsule against the mucosal wall of the esophagus that simultaneously measures pH and transmits the data to a receiver attached to the patient's waist. The Bravo pH Monitoring System™ and Accessories consists of four main components: Bravo pH Capsule with Delivery System, Bravo pH Receiver, RAPID pH and PolygramNet software, and Bravo pH Delivery System Accessories.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Bravo pH Monitoring System. It primarily focuses on the 510(k) submission for substantial equivalence to a predicate device.

However, based on the limited information, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided in the document. The submission states that the device is substantially equivalent to a predicate device (Bravo pH Monitoring System™ and Accessories, K002028) and that "Performance Data: Clinical data has been summarized to show safety and effectiveness for the proposed indications for use." However, the actual summary of this clinical data or details of how effectiveness was measured are not present.

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

The document mentions "Clinical data has been summarized," but it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document describes the "RAPID pH and PolygramNet software" as intended to "record, store, view, and analyze gastroesophageal pH data, enabling physicians to interpret study results." However, it does not mention any MRMC comparative effectiveness study or any AI component that would assist human readers and quantify their improvement. The technological characteristics are stated to be "exactly the same as the predicate devices," suggesting the focus is on maintaining existing performance rather than demonstrating improvements through AI.

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

The document mentions software for recording, storing, viewing, and analyzing data. However, it does not describe any standalone algorithm performance study without human interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The document mentions "gastroesophageal pH measurement and monitoring of gastric reflux." The "ground truth" for this device would inherently be the pH values themselves, measured by the pH telemetry capsule. However, the exact methodology for establishing the accuracy or "truth" of these pH measurements (e.g., against a gold standard pH meter) is not detailed in this summary.

8. The Sample Size for the Training Set:

This information is not provided in the document. Given the device's nature (pH measurement and monitoring) and the indication of substantial equivalence to a predicate, it's unlikely a "training set" in the machine learning sense was a primary focus for this particular 510(k) submission, unless the software used advanced algorithms that are not explicitly mentioned.

9. How the Ground Truth for the Training Set was Established:

This information is not provided in the document.

In summary, the provided 510(k) summary is focused on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods. The core claim is that the updated Bravo pH Monitoring System™ and Accessories has "technological characteristics... exactly the same as the predicate devices" and that "Clinical data has been summarized to show safety and effectiveness for the proposed indications for use," leading to the conclusion that it "does not raise new issues of safety or effectiveness."

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