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The intended use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

Varian's High Dose Rate BrachyTherapy Afterloaders use a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The radioactive source is enclosed within a wire/cable which is driven via coupling catheters /Transfer Guide Tubes / Source Guide Tubes from the Applicator in to the patient.

The provided text is a 510(k) summary for the Centering Intraluminal Applicator. It describes the device, its intended use, and claims substantial equivalence to a predicate device (K983436 - GammaMed Plus High Dose Rate Remote Afterloading System).

However, the document is a regulatory submission and approval letter, not a study report or clinical trial summary. Therefore, it does not contain the specific information requested regarding acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or clinical study details.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical efficacy and performance data in the same way a clinical trial for a novel drug or high-risk device might. The "summary of the technological characteristics" mentioned refers to a comparison chart in Tab 7 of the original submission, which is not included in the provided text. This chart would detail how the new device's features are similar to or different from the predicate, implying that if the technological characteristics are sufficiently similar and the predicate is safe and effective, then the new device is also considered safe and effective for the stated indications.

Therefore, it is not possible to extract the requested information from the provided text.

To answer your questions, one would typically look for a separate clinical or performance study report, which is not part of this 510(k) summary.

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