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The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Pattison Esophageal Dilator." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance data or studies that establish novel acceptance criteria. The focus is on comparing the new device's design, materials, indications for use, and performance characteristics to those of an already legally marketed device.

Therefore, I cannot extract the requested information from the provided text because it is not present.

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The Tri-Med #ES-32 Suction Catheter is to be used to suction liquids and solids from the stomach and esophagus when deemed necessary by the physician.

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The provided text is a 510(k) clearance letter from the FDA for a medical device: the Tri-Med #ES-32 Suction Catheter. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria for a novel AI or diagnostic device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, adjudication methods, and AI-specific metrics is not available in the provided text.

The document states:

"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."

This indicates that the device was cleared because it was found to be substantially equivalent to an existing, legally marketed device, not through a performance study against predefined acceptance criteria as would be typical for new, complex diagnostic or AI-driven technologies.

In summary, none of the specific information requested in your numbered points can be extracted from the provided text. The text does not describe acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related metrics.

Ask a specific question about this device

Ask a specific question about this device