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The Sirius MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: Iodine 125 (1251), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation.

The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either gamma radiation or ethylene oxide.

C4 Imaging's Sirius MRI Marker NS consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.

The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation.

The provided text is a 510(k) summary for the Sirius MRI Marker NS, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for acceptance criteria in the traditional sense of a diagnostic or interventional AI/CADe/CADx device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission as it does not describe a clinical performance study of the device's diagnostic or interventional capabilities.

The submission is primarily concerned with proving that the Sirius MRI Marker NS, which is an accessory device, is as safe and effective as a legally marketed predicate device (MRI Marker K131689), despite minor differences in sterilization and packaging. It explicitly states there are "no differences between the proposed device Sirius MRI Marker NS and the predicate device with regard to dimension, composition of the fill solution, and manufacturing process of the marker itself that would affect the safety or effectiveness of the proposed device."

The "Indications for Use" section (page 3 and 5) describes the intended purpose of the device: "to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation." This is a functional description, not a performance metric that would require a study with the criteria listed in the prompt.

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