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The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below:

• Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers
• Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ●
  The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy.
  The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium.
  The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker 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: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted.
  The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter.
  The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below.
  The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.

The provided text is a 510(k) summary for the Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, this document explicitly states that "No performance data testing was performed as each of the components has been previously cleared for this intended use." and "No additional biocompatibility test was performed as biocompatibility evaluation was conducted for each of the components in previous regulatory clearances."

Therefore, the supplied text does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics. It indicates that the device's components (Cs-131 implant devices and Sirius™ MRI Markers) were previously cleared and have established safety and effectiveness.

As a result, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is explicitly stated as not having been performed for this specific 510(k) submission.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Identical product code, regulation number, device classification name, and device classification.
• Similar indications for use, with the subject device's indication being a combination of the predicate and reference device, specifically limiting use to the prostate due to the MRI markers.
• Similar principle of operation.
• Identical condition of use, Rx or OTC status, materials of construction (for the core components), packaging, and sterilization method. The new combination device incorporates the MRI markers, which were previously cleared.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and a performance study, as the filing strategy for this device was based on substantial equivalence to pre-cleared components rather than new performance testing.

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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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The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (1851). Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

C4 Imaging's MRI Marker™ consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) 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.

Here's an analysis of the provided text regarding the MRI Marker, addressing your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the safety and effectiveness of the MRI Marker, rather than specific performance metrics against pre-defined acceptance criteria in the traditional sense of diagnostic accuracy or sensitivity/specificity. The criteria are largely related to established medical device standards and the device's intended function.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of diagnostic performance (e.g., a specific number of images or patients for evaluation). The performance demonstrations are through:

• Sterilization Validation: No explicit sample size mentioned for this, as it's a validation of a process.
• Biocompatibility Testing: "In vivo and in vitro tests were performed." No specific numbers of samples or animals are provided.
• MRI Safety Testing: No specific sample size mentioned for the devices tested.
• Radiographic Visualization: "Phantom prostate imaging testing" (implies one or more phantoms) and "X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles." No specific number of phantoms, strands, or needles are given.
• Animal Testing: "Animal testing indicates..." No specific number of animals or data provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies described are technical performance tests (e.g., sterilization, biocompatibility, MRI compatibility) and visualization tests using phantoms or animal models, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as there is no mention of a human-read test set requiring adjudication in the context of the described performance testing.

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, an MRMC comparative effectiveness study was not done. The device (MRI Marker) is a physical marker for brachytherapy seeds, not an AI or software algorithm itself that would assist human readers in interpretation.

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

No, a standalone performance study in the context of an algorithm or AI was not done, as the MRI Marker is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the various tests was primarily based on:

• Sterilization: Industry standards (ISO 11137) and laboratory verification (e.g., absence of microbial growth).
• Biocompatibility: Established biological endpoints (e.g., absence of irritation, toxicity) as defined by ISO 10993-1 and observed in in-vitro, in-vivo, and animal models.
• MRI Safety: Measurement of physical forces (displacement, torque) and temperature changes according to ASTM standards.
• Radiographic Visualization & Spacing: Direct observation of images (MRI and X-ray) to confirm the presence of a positive signal and appropriate spacing in phantoms and simulated setups.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MRI Marker is a physical device and does not involve AI or machine learning algorithms that would require a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided. As above, there is no training set for this device.

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