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The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.

Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.

This FDA 510(k) summary for the "Sure-Point™ HDR Needle Template" (K031273) does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

This document is a declaration of substantial equivalence to existing predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already on the market, based on similar intended use, technological characteristics, and materials.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, ground truth information, or details about comparative effectiveness studies, because this information is not present in the provided text.

Here's what I can infer from the document:

• Device Type: This is a physical medical device (a template for brachytherapy needles), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC.
• Approval Basis: Substantial equivalence, not based on a new performance study demonstrating effectiveness against specific acceptance criteria.
• Study Data: No study data is mentioned, as is common for many 510(k) submissions of physical medical devices demonstrating substantial equivalence.

If you have a document describing a performance study for an AI/software device, I would be happy to analyze it according to your prompt.

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