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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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