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The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Celsite® Dual Venous Access System." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Key information:

• Acceptance Criteria and Device Performance: The document does not contain acceptance criteria or study results demonstrating device performance against such criteria. It's an approval letter based on "substantial equivalence" to a predicate device, not a performance study report.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As this is an FDA clearance letter based on substantial equivalence, rather than a clinical trial or performance study report, none of this information is available within the provided text. The FDA determines substantial equivalence based on a comparison to predicate devices regarding indications for use, technological characteristics, and safety and effectiveness information, but the specific performance data against quantified acceptance criteria and the detailed study design elements you've asked for are typically found in the 510(k) submission itself, not the clearance letter.

Therefore, for this specific input, I must state that the requested information regarding acceptance criteria, device performance, and study details is not provided in the given FDA clearance letter.

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The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation theropy.

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The provided text is a 510(k) clearance letter from the FDA for a medical device (B. Braun Impact Balloon Dilatation Catheter). It determines substantial equivalence to a predicate device but does not contain any information about acceptance criteria or a study proving device performance against such criteria.

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

The document focuses on the regulatory clearance process, specifically the FDA's determination of substantial equivalence, which is a different aspect of device approval than a specific performance study against acceptance criteria.

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