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The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.

The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.

The applicator set in this submission is designed to be used with all Varian afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicator will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.

The cervical stop is a stainless steel component that is placed on the applicator probe during HDR and PDR brachytherapy treatment of the uterus. It provides a physical stop for depth of insertion.

The provided text is a 510(k) Premarket Notification summary for medical devices (Shielded Applicator Set and Cervical Stop) used in brachytherapy. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain information about an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI/ML device cannot be extracted from this document.

However, I can extract the general acceptance criteria and the type of non-clinical study performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable as this is not an AI/ML device. The document discusses non-clinical bench testing of physical devices. The "test set" would refer to the physical samples of the devices tested. The provenance of the data is from Varian Medical Systems' internal bench testing.

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

• Not applicable as this is not an AI/ML device requiring expert ground truth for image or diagnostic data. Ground truth for mechanical and functional performance is established through engineering and physics principles by the manufacturer.

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

• Not applicable as this is not an AI/ML device. Adjudication methods are typically used for disagreements in human interpretation of diagnostic data.

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:

• No. This document explicitly states, "No clinical tests have been included in this pre-market submission." An MRMC study is a clinical study involving human readers.

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

• Not applicable as this is not an AI/ML device.

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

• For the non-clinical bench tests, the "ground truth" would be engineering specifications, physical measurements, and compliance with recognized standards (e.g., source positioning accuracy, material properties, sterilization effectiveness, usability per IEC 62366:2007).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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