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The Fletcher CT/MR Shielded Applicator Set is a modification of the Fletcher Williamson Applicator Set (K983341). It is a gynecological applicator for brachytherapy procedures. The applicator uses one intrauterine tube and two ovoid tubes for treatment of the cervix and endometrium cancer. The tubes quide the radioactive source of the afterloader to the location where treatment is to be applied. Tungsten allov shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields. The Fletcher CT/MR Shielded Applicator Set is available in two variations and is compatible with Nucletron afterloaders and accessories.

AI/ML Overview

This document is a 510(k) summary for the Nucletron BV Fletcher CT/MR Shielded Applicator Set. It acts as a premarket notification for a modified medical device. The information provided heavily focuses on demonstrating "substantial equivalence" to a predicate device rather than comprehensive clinical study data typical for a new AI/software device. As such, many of the requested fields cannot be directly extracted or are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or performance metrics in the format typically seen for a new AI/software medical device. The "acceptance criteria" here are implied by the demonstration of "substantial equivalence" to a legally marketed predicate device (Nucletron BV Fletcher Williamson Applicator Set, K983341).

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	The applicant states, "No safety or effectiveness issues were identified." This is the overarching claim for substantial equivalence.
Technological Equivalence	"The operating principle is the same as the marketed device. The modified design combines the characteristics of the marketed device (shielding in the ovoids) with materials that allow CT and MR imaging, enabling 3D treatment planning." "Ovoid and intrauterine dimensions of the modified device are comparable to the marketed devices."
Imaging Compatibility	"Tungsten alloy shielding is incorporated in the ovoid to lower the dose in organs like rectum and bladder during treatment. The shielding position in the ovoid is adjustable, enabling CT imaging with few artifacts. For MR data acquisition and X-ray it is not necessary to move the shields." "The device was tested for use in the MR and CT environment."
Performance Requirements	"Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the modified device performance is equivalent to the marketed devices." (Specific performance metrics are not detailed, but the equivalence to predicate device performance is claimed).
Sterilization & Biocompatibility	"Validation of sterilization processes and biological evaluation was performed." (Details of methods and results not provided within this summary).

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The "testing" mentioned is primarily related to bench testing, sterilization, biological evaluation, and MR/CT compatibility. These tests typically involve a sample of the physical device, not an imaging dataset for AI evaluation.
Data Provenance: Not applicable in the context of an AI/software device. This is a physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. Ground truth, in the context of an AI/software device, involves expert labeling of data. This document describes a physical medical device.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication method: Not applicable.

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:

MRMC Study: No, this is not an AI/software device, but a physical brachytherapy applicator. Therefore, no MRMC study involving human readers and AI assistance was performed or described.

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

Standalone Performance: Not applicable. This is not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: For this physical device, "ground truth" would be established through engineering specifications, material properties, physical measurements, and performance benchmarks validated against the predicate device. For example, the "truth" for shielding effectiveness would be measured dose reduction, and for imaging compatibility, it would be the quality of the CT/MR images with the device in place (e.g., artifact levels). Specific details are not provided beyond the general statement of "bench testing" and "meeting performance requirements."

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This is not an AI/Machine Learning device.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable.

Summary Explanation:

This 510(k) summary is for a physical medical device, specifically a gynecological brachytherapy applicator. The "study" referenced is primarily bench testing, sterilization validation, biological evaluation, and MR/CT compatibility testing to demonstrate that the modified device (Fletcher CT/MR Shielded Applicator Set) is substantially equivalent to a previously legally marketed predicate device (Fletcher Williamson Applicator Set, K983341).

The document's purpose is to show that despite modifications (incorporating tungsten alloy shielding for CT/MR imaging compatibility), the new device operates on the same principle, has comparable dimensions, and meets performance requirements similar to the predicate device, with no new safety or effectiveness issues. The acceptance criteria are therefore implicit in proving this substantial equivalence across various engineering and performance attributes, rather than explicit statistical thresholds for diagnostic accuracy metrics typically associated with AI/software devices.

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