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The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy.

The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.

The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.

Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:

Acceptance Criteria and Device Performance (for a non-AI physical device)

The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))

Study Information (as applicable to a non-AI physical device 510(k) submission):

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

   • N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
   • For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
   • Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.

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

   • N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.

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

   • N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or performance.

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:

   • No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.

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

   • N/A: This is a physical medical device, not an algorithm.

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

   • N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").

7. The sample size for the training set:

   • N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.

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

   • N/A: Not applicable.

In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.

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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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