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The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Henschke Type GYN applicator which is the subject of this 510(k) is a component of the VariSource system.

Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.

The provided document is a 510(k) summary for the Varian VariSource Henschke Type GYN Applicator. This document is a premarket notification to the FDA for a medical device and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

Instead, it focuses on demonstrating "substantial equivalence" to a predicate device (Mick Radio-Nuclear Instruments, Inc., Henschke Afterloading Applicator, K871217). The document primarily presents a comparison of the technological characteristics between the new device and the predicate device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This type of data is not included in the provided document. The 510(k) is about demonstrating equivalence, not necessarily meeting specific performance criteria that would be derived from a clinical trial or extensive performance testing.
2. Sample size used for the test set and the data provenance: No test set or associated data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described as there is no test set.
4. Adjudication method for the test set: Not applicable as there is no test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical applicator, so "algorithm only" performance is not relevant.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to show that the new device has similar fundamental technological characteristics and intended use as a device already cleared by the FDA, implying it is as safe and effective. It does this through a comparative table of physical features and materials.

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