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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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Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

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Here's an analysis of the provided text regarding the Sandhill Scientific PediaTec™ pH Probe:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, no specific performance acceptance criteria or detailed device performance results are explicitly stated. The submission is for a modification to an existing approved 510(k) to add an indication for use with pediatric populations. It states that "There is currently no performance standard for pH probes."

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

The 510(k) summary does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The submission is primarily focused on demonstrating substantial equivalence to a previously cleared device (Sandhill Disposable Internal Reference pH probe cleared under K931963/A, September 28, 1994) for an expanded indication of use in pediatric populations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

There is no mention of experts or the establishment of ground truth for a test set in the provided document.

4. Adjudication Method for the Test Set

No adjudication method is described, as there's no mention of a test set or associated study in the provided text.

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

No MRMC study is mentioned. This device is a pH probe, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical pH probe, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The document does not describe any specific ground truth for a study. For a pH probe, the "ground truth" would typically refer to the accuracy of its pH measurement against known standards. However, the document does not detail such testing for this submission.

8. Sample Size for the Training Set

No training set is mentioned as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as there is no training set for this device.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The provided 510(k) summary (K013951) for the Sandhill Scientific PediaTec™ pH Probe is a regulatory submission for a modification to an existing device (Sandhill Disposable Internal Reference pH probe, K931963/A) to expand its indication to pediatric populations.

Crucially, the document does not describe a clinical study or specific performance testing against acceptance criteria to "prove the device meets acceptance criteria" in the way a new, high-risk device or an AI/software device often would. Instead, the basis for approval is "Substantial Equivalence" to a legally marketed predicate device (K931963/A). The FDA cleared the device based on the assessment that it is substantially equivalent to the predicate device for the stated indications for use, without requiring new performance standards or a detailed clinical study for the pediatric population. The document explicitly states, "There is currently no performance standard for pH probes."

Therefore, the "study" proving the device meets criteria is implicitly the demonstration of similarity to the predicate device, rather than a new, comprehensive performance study outlined in the provided text.

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The pH Analysis Module is a software program that has been designed to analyze intragastroesophageal pH data recorded from the gastrointestinal tract in pediatric and adult populations.

The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include min and max values, length of selection.

By adding the pH Analysis Module to the Polygram Software for Windows, the user can also have all the intragastroesophageal pH data analyzed (data recorded from the gastrointestinal tract in pediatric and adult population). The analysis report includes sections such as patient demographics; intepretation and comment (for user to insert); procedure summary; pH tracing; period table including number such as duration of recording, number of periods of interest, time where pH was below certain threshold value, symptom correlation, scoring; physician signature section.

The analysis report can then serve as a part of the physician's diagnosis and post treatment evaluation.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) summary for a pH Analysis Module, focusing on its description, intended use, and equivalence to a previously cleared device. It lacks details regarding specific performance metrics, sample sizes for testing, expert involvement, or ground truth establishment.

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