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The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

The Axxent Cervical Applicator is a component of the Axxent Electronic Brachytherapy System (cleared under K122951) which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR X-ray source to deliver high-dose rate, low energy radiation treatment to the uterus, cervix, endometrium and vagina. The Axxent HDR X-ray source mimics the penetration and dose characteristics of Iridium-192.

The Axxent Cervical applicator is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use. An Applicator Clamp is a required accessory to stabilize the Cervical Applicator during radiation treatment.

The provided document is a 510(k) premarket notification for the Axxent® Cervical Applicator, primarily focused on adding MRI compatibility and MR Conditional labeling. It is not an AI/ML device, and therefore, many of the requested criteria related to AI/ML device performance and studies are not applicable.

However, I can extract information related to the acceptance criteria and the study performed for the MRI compatibility of the device, as that is the specific new claim being sought.

Here's the information regarding the MRI compatibility study:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the results of the testing "indicated that, in accordance with the guidance of relevant ASTM standards, Xoft's Cervical Applicator should be labeled MR Conditional." This implies that the device successfully met the established thresholds and requirements outlined in each ASTM standard for magnetic displacement, torque, artifact, and heating, thereby qualifying for MR Conditional labeling. Specific numerical thresholds or measured values are not provided in this summary.

2. Sample sized used for the test set and the data provenance

• Sample size: "Test samples were provided in their final manufactured condition." The exact number of samples tested is not specified, but it implies a sufficient number of devices were used for each test to achieve reliable results as per the ASTM standards.
• Data provenance: Not explicitly stated, but given it's a submission to the FDA by a US-based company, the testing was likely conducted in a controlled laboratory environment, presumably in the US. It is a prospective study as tests were conducted specifically for this submission.

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

• This question is not applicable as this is a device compatibility test, not an AI/ML diagnostic or prognostic study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" here is adherence to engineering standards for MRI safety.

4. Adjudication method for the test set

• Not applicable. This involves objective physical measurements and adherence to ASTM standards, not subjective interpretation requiring adjudication among experts.

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

• Not applicable. This is not an AI/ML device and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" in this context is established by the ASTM consensus standards (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) for evaluating MRI compatibility. Performance is judged against the objective physical criteria and thresholds defined within these standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

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

• Not applicable. This is not an AI/ML device; there is no training set.

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