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The pHTip™ Disposable ISFET Catheter is a device used to measure intragastric and intraesophageal pH activity in the stomach or esophagus, by means of a flexible lead with ISFET pH electrodes that is introduced through the nose into the gastrointestinal tract. It is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

The pHTIP Disposable ISFET Catheter is a device used to measure pH activity in the stomach or esophagus by means of a probe with transducers, which is introduced through the nose into the gastrointestinal tract, and is intended especially for gastro esophageal testing for the severity of acid reflux events. The device may include conductive rings for impedance studies, and may also include signal conditioning and amplifying equipment.

The provided 510(k) summary for the pHTip™ Disposable ISFET Catheter states that no clinical tests were conducted or relied upon to determine substantial equivalence. Instead, non-clinical bench testing was performed to validate the design against the company's specified design requirements. This means the information requested about acceptance criteria and study details tied to human clinical performance will not be available in this document.

Here's the information explicitly stated or inferred from the document:

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

The document does not provide a table of specific acceptance criteria or quantitative performance metrics from the non-clinical bench testing. It broadly states that "Non-clinical bench testing was performed in order to validate the design against the company's specified design requirements" and "Functionality of the pHTip Disposable ISFET Catheter was validated under simulated use conditions."

Therefore, we cannot populate this table with specific values.

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

Not applicable, as no clinical studies were performed. The non-clinical bench testing details (sample size, data provenance) are not provided.

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, as no clinical studies were performed and thus no ground truth established by experts in a clinical context. For non-clinical bench testing, the "ground truth" would likely be based on calibrated reference measurements, but details are not provided.

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

Not applicable, as no clinical studies were performed requiring adjudication of expert interpretations.

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, as this is solely a medical device for measuring pH, not an AI-assisted diagnostic tool.

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

This refers to the device itself as a standalone measurement tool. The document implies that the device's functionality was tested in stand-alone mode during non-clinical bench testing, but no specific performance metrics are provided.

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

For the non-clinical bench testing, the "ground truth" for pH measurements would typically be established by calibrated reference solutions or systems. However, the document does not explicitly state this.

8. The sample size for the training set

Not applicable, as this device primarily relies on physical and chemical principles for measurement, not an AI model requiring a training set.

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

Not applicable, as there is no AI model or training set mentioned for this device.

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