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The ADAPI™ Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device called the "ADAPT™ Balloon Open Access Port Model 41244," dated December 13, 2002. It outlines the regulatory approval for this device, stating that it is substantially equivalent to legally marketed predicate devices.

This document describes the device, its indication for use, and regulatory information, but it does not contain any information about acceptance criteria for device performance, a study proving it meets such criteria, or details regarding AI or algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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The ADAPt™ Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

ADAPt™ Open Access Port, Model 41233

I apologize, but the provided text is a 510(k) clearance letter from the FDA concerning the "Adapt™ Open Access Port, Model 41233." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance determines if a new medical device is "substantially equivalent" to an existing, legally marketed device (predicate device). It generally doesn't require new clinical studies or detailed performance data comparing the new device against specific acceptance criteria in the way you've described for an AI or diagnostic device. Instead, the manufacturer provides information showing that their device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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Intended Use: To provide an access port into the peritoneal cavity.

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This appears to be a 510(k) clearance letter from the FDA for a Peritoneal Catheter. This document does not include information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly 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..."
• "This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the device received marketing clearance based on a demonstration of substantial equivalence to a predicate device, not necessarily on a performance study against specific acceptance criteria. While the manufacturer would have performed testing to support the 510(k) submission, the details of that testing, acceptance criteria, and study results are not contained within this FDA clearance letter.

Therefore, I cannot provide the requested information based on the input document. The document is an FDA clearance letter, not a study report or a summary of acceptance criteria and performance data.

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For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.

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The provided text is a 510(k) clearance letter for a Peritoneal Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The letter is a regulatory approval document and not a scientific or clinical study report. Therefore, I cannot extract the requested information as it is not present in the provided text.

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THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance testing, or any studies conducted on the device "Introducer Port SC" (K972112). The document is solely an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain details regarding performance studies, clinical trials, or any specific acceptance criteria that the device had to meet.

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Ask a specific question about this device

Ask a specific question about this device