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The ART Shielded Breast Applicator is intended for use with Nucletron or Varian remote afterloading HDR equipment for non-invasive brachytherapy of the breast in areas of intact skin.

The Advanced Radiation Therapy (ART) Shielded Breast Applicator is used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned either external to a mammography style paddle which immobilizes the breast or directly against the breast with intact skin. Once the target has been immobilized and imaged the applicator is placed such that it is aligned with the target. The exterior shielding of the applicator will reduce dose to the surrounding tissue. The applicator is available in 5 sizes - 4, 5, 6, 7 and 8 cm ID.

Here's a breakdown of the acceptance criteria and study information for the ART Shielded Breast Applicator, based on the provided text:

Acceptance Criteria and Device Performance

Explanation: The provided text explicitly states: "The Advanced Radiation Therapy Shielded Breast Applicator is a passive device. Performance testing was not required." This indicates that the device's substantial equivalence was based on its similarity to predicate devices and not on specific performance metrics or a formal study with acceptance criteria.

Detailed Study Information (Where Applicable)

Given the statement "Performance testing was not required," much of the following information is not present in the provided document.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not applicable, as no performance testing was required or conducted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable, as no performance testing was required or conducted.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as no performance testing was required or conducted.

4. 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:

   • Not applicable. This device is a passive medical device, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a passive medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable, as no performance testing was required or conducted.

7. The sample size for the training set:

   • Not applicable, as no algorithm or AI model was developed or trained for this passive device.

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

   • Not applicable, as no algorithm or AI model was developed or trained for this passive device.

Summary of Study Conducted:

The premarket notification for the ART Shielded Breast Applicator did not involve a formal performance study with acceptance criteria. Instead, the basis for clearance was a Statement of Equivalency demonstrating substantial equivalence to three legally marketed predicate devices:

• Advanced Radiation Therapy - ART Breast Brachytherapy Applicator - K060299
• Mick Nuclear - HDR-IORT Shielded Applicator - K052351
• Varian Medical Systems - Shielded Applicator Set - K033371

The document states that the ART Shielded Breast Applicator provides "the same or similar functions" and that its "intended use, statement of indications, and technological and performance characteristics support the concept of substantial equivalence" to these predicates. As a passive device, performance testing was deemed unnecessary by the manufacturer and, implicitly, by the FDA for the 510(k) clearance process.

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