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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 Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Varian VariSource Endometrial Applicator, which is a component of a remote high dose rate afterloader system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent performance data against specific acceptance criteria.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the given text.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" and "device performance" as might be seen for a new, de novo device are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device (Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216).

The comparison provided is primarily a feature-by-feature technological comparison, which serves as the "study" to prove it meets the criteria of substantial equivalence.

Feature	Predicate Device (MRNI Hilaris-Nori Endometrial Applicator, K871216)	Varian VariSource Endometrial Applicator (K980576)	Acceptance "Criterion" (Substantial Equivalence)	Reported "Performance" (Comparison)
Afterloading Method	Manual	Remote HDR	Must be suitable for brachytherapy	Different method, but both achieve brachytherapy
Coupling Catheter Fittings	No	Yes	Must allow connection to afterloader	Presence of fittings for remote HDR system
Vaginal Cylinder Diameter & Length	2.5 cm X 6, 7, 8, 10, & 12 cm; 3.0 cm X 6, 7, 8, 10, & 12 cm	3.1 cm X 10.2 cm	Must be appropriately sized for intended use	Slightly different, but within expected range for endometrial application
Vaginal Cylinder Material	Delrin	Polysulfone	Biocompatible, suitable for radiation environment	Both are medical-grade polymers
Irradiation Tubes Number	3: 1 straight, 2 curved	3: 1 straight, 2 curved	Provides necessary channels for source placement	Identical number and configuration
Irradiation Tubes Material	Stainless steel	Stainless Steel	Biocompatible, durable, radiation-transparent	Identical material
Irradiation Tubes Diameter & Length	6 mm X 24 cm	Straight: 3 mm X 38.1 cm; Curved: 3 mm X 36 cm	Suitable dimensions for accurate source delivery	Different dimensions, but designed for specific afterloader system
Fixation	Snap Lock	Pivot Assembly Lock	Secure attachment	Different mechanism, but serves same function

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is a comparison to a predicate device, not a performance study involving a patient test set. The "test" is the comparison of technical characteristics to the predicate device.

The data provenance is the design specifications and materials of the Varian VariSource Endometrial Applicator compared against the known characteristics of the predicate device. It's a review of documentation, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable. Ground truth in this context refers to the documented specifications of both the proposed and predicate devices. The "experts" are the Varian Oncology Systems team who prepared the 510(k) and the FDA reviewers who assessed the submission. Their qualifications would be in regulatory compliance, engineering, and medical device evaluation, but they are not establishing a "ground truth" for a performance study.

4. Adjudication Method for the Test Set

This is not applicable. There's no "adjudication" in the sense of resolving discrepancies in expert interpretations of data. The comparison is based on documented technical specifications. The FDA's review process serves as the "adjudication" of the substantial equivalence claim.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The device is a physical medical applicator for brachytherapy, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the documented technical specifications and intended use of both the Varian VariSource Endometrial Applicator and its chosen predicate device, the Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator (K871216). This is a features-based comparison to demonstrate that the new device is as safe and effective as the predicate device.

8. The Sample Size for the Training Set

This is not applicable. There is no training set involved as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

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