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The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set

The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images.

The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.

The devices are used as accessories to the Nucletron microSelectron Afterloaders

This document is a 510(k) summary for a medical device (Nucletron's Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set) seeking clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment for a standalone or comparative effectiveness study is not available in the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a structured table as it would be for a performance study. The core "acceptance criteria" for this submission is demonstrating substantial equivalence to a legally marketed predicate device. The "performance" described relates to the features and intended use of the new device being similar to the predicate.

   • Acceptance Criteria (Implicit for 510(k) Special): Substantial equivalence to the predicate devices (Ring CT/MR Applicator Set and Standard CT/MR Applicator set, K983341) regarding:

     • Intended Use (Gynecological brachytherapy for cancer treatment of cervix and endometrium, with optional interstitial brachytherapy).
     • Technological Characteristics (Polymer construction for CT/MR compatibility, similar design with added guiding holes for interstitial needles).
     • Safety and Effectiveness (Not explicitly stated in detail, but inferred by substantial equivalence).

   • Reported Device Performance (Implicit):

     • Allows placement of guiding tubes for Proguide needles.
     • Enables asymmetric alteration of dose distribution.
     • Fully CT/MR compatible due to polymer composition, eliminating distortion.
     • MR line markers can make channels visible on MR images.
     • Functions as an accessory to Nucletron microSelectron Afterloaders.

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

   • Not applicable (N/A). This document describes a medical device seeking 510(k) clearance based on substantial equivalence, not a performance study involving a test set of data or patient samples. The "data" here refers to the device's design specifications and comparison to a predicate.

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

   • Not applicable (N/A). No test set or ground truth derived from experts is detailed in this 510(k) summary.

4. Adjudication Method for the Test Set:

   • Not applicable (N/A). No test set or adjudication process is detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This document does not describe an MRMC comparative effectiveness study to assess human reader improvement with or without AI assistance. This is a traditional 510(k) submission for a physical medical device (applicator set), not an AI/software device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No. This is not an AI/algorithm-based device. No standalone performance study for an algorithm is described.

7. The Type of Ground Truth Used:

   • Not applicable (N/A). The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) does not apply directly to this 510(k) submission. The "ground" for comparison is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

   • Not applicable (N/A). This is not an AI/machine learning device that requires training data.

9. How the Ground Truth for the Training Set was Established:

   • Not applicable (N/A). As above, this is not an AI/machine learning device.

In summary, the provided document is a regulatory submission for device clearance, not a study report detailing performance against specific acceptance criteria in the manner one might expect for a diagnostic or AI-driven device. The focus is on demonstrating that the new applicator set is "substantially equivalent" to existing, cleared devices.

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