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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 System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH 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 pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components.

The provided text describes a 510(k) Notification for a pH Testing System, focusing on its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically found for AI/ML medical devices. The document is primarily a comparison to a predicate device to demonstrate substantial equivalence, rather than a performance study with defined criteria.

Based on the provided text, here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics (e.g., accuracy, sensitivity, specificity) for the new device. Instead, it relies on demonstrating that the enhanced system performs "as its predicate system."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Field tests are on going." This indicates that any clinical performance data was not yet complete or available at the time of submission for this 510(k). Therefore, there is no disclosed sample size or data provenance for a test set. The submission focuses on non-clinical (engineering and functional) equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set involving human expert adjudication for ground truth establishing is described. The assessment is based on technical verification against the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set involving human expert adjudication for ground truth establishing is described.

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

Not applicable. This device is a pH testing system primarily for data acquisition and analysis, not an AI/ML diagnostic tool that would typically involve human readers using AI assistance. The study described is a non-clinical verification of equivalence.

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

The document reports on "Verifications results shows that the enhanced system performs as its predicate system." This implies that standalone functional tests and comparisons were performed to ensure the new Digitrapper Delta and Polygram '98 software performed equivalently to the older system. The resolution improvement from 0.04 pH to "better than 0.01 pH" is a standalone performance metric. However, explicit details of these tests (e.g., number of test cases, methodology) are not provided beyond the general statement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance assessment, the "ground truth" was the performance of the predicate system. The new device's performance was measured against the established performance and technical specifications of the Medtronic Synectics Digitrapper MK III and its associated software.

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (pH testing system) and does not refer to AI/ML components that would require a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI/ML component is mentioned.

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The Kongsberg Instruments Inc. Motility Probe is manufactured for use in the evaluation and diagnosis of gastrum lerological dysfunction related to muscir tonus and the coundination of contractions between muscle groups. The Motility frobe provides several types of information with may be used in these diagnoses. Primary among these is pressure information at multiple sensor sites. Secondary to the pressure information is the ability of the probe to measure pH in the Stomach and esophagus. This can reveal the presence of gastric reflux from the stomach into the esophair.

Motility Probes: models P31-P38, P40-P43, and P50

This document is a 510(k) clearance letter from the FDA for a medical device called "Motility Probes." It does not contain a study proving the device meets acceptance criteria, nor does it provide acceptance criteria or device performance data.

Instead, this letter confirms that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market, based on the information submitted by the manufacturer, Konigsberg Instruments, Inc. This clearance allows the manufacturer to market the device for the stated Indications for Use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval, not a scientific study report.

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