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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 C4 Fiducial Marker is indicated to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The device can be visualized using MRI, CT or x-ray, and provides a reference from which other procedures can be guided.

The C4 Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer tube containing a solution of up to 1% cobalt chloride and up to 2% N-Acetylcysteine, The ratio of cobalt chloride to N-Acetylcysteine is 1:2. Zirconium oxide is sealed within the polymer shell of the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm (+/- 0.2 mm).

This document is a 510(k) premarket notification for a medical device, the C4 Fiducial Marker, and does not contain information about a study that measures the device's performance against specific acceptance criteria in the manner requested (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

Instead, this document describes the device, its intended use, and demonstrates substantial equivalence to previously cleared predicate devices through performance testing related to device integrity and visualization capabilities rather than clinical efficacy metrics.

Here's a breakdown of the information that can be extracted, and what is not available in the provided text:

Information Available:

• Device Name: C4 Fiducial Marker
• Intended Use: To be implanted into the body to mark the location of specific anatomy (normal or diseased) for a future medical procedure. The device can be visualized using MRI, CT, or X-ray, and provides a reference for guiding other procedures.
• Predicate Devices:
  • Mixed media marker (K102506) from Cortex Manufacturing
  • BiomarC Fiducial Marker (K063193) from Carbon Medical Technologies
• Reference Device: C4 Imaging MRI Marker NS (K171487)
• Testing Performed (categorized as "Performance Testing"):
  • Structural and functional integrity testing (negative and positive pressure, axial and lateral load testing).
  • MRI, CT, and X-ray imaging demonstrating functional performance.
  • Separate MRI, CT, and X-ray imaging tests performed in tissue equivalent phantoms.
  • Biocompatibility (ISO 10993) assessment.
  • Endotoxin tests.

Missing Information (not detailed in the provided text for this 510(k) summary):

1. Table of Acceptance Criteria and Reported Device Performance (Clinical/Diagnostic Accuracy): The document does not provide specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, localization accuracy in a clinical context) or reported values against such criteria. The "performance testing" described is for device integrity and basic visualization, not clinical effectiveness.
2. Sample Size used for the test set and data provenance: Not applicable in the context of clinical accuracy or a test set as described for AI evaluation. The device integrity and visualization tests would have used a sample of the manufactured markers, but specific numbers are not provided, nor is information on the provenance of "data" in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The "ground truth" for the tests performed would be related to physical properties, not expert consensus on clinical findings.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study was not mentioned. The device is a physical marker, not an AI or imaging interpretation tool that would involve human readers.
6. Stand-alone (algorithm only without human-in-the-loop performance) study: No, this is not an AI algorithm.
7. Type of ground truth used: For the device integrity tests, the ground truth would be the physical integrity of the device (e.g., no leaks, ability to withstand loads). For visualization, the ground truth is simply the visual presence and distinctness of the marker on imaging modalities, often evaluated in phantoms. This is not clinical ground truth like pathology or outcomes data.
8. Sample size for the training set: Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "acceptance criteria" and "study":

The "acceptance criteria" for this device (as inferred from the "Performance Testing" section) relate to:

• Structural and Functional Integrity: The marker must maintain its integrity under various pressures and loads. While specific numerical acceptance criteria (e.g., "withstanding X psi pressure" or "withstanding Y N axial load") are not stated, the tests imply that the device must pass these challenges without failure (e.g., leaking, breaking).
• Visualization: The marker must be visible on MRI, CT, and X-ray in tissue-equivalent phantoms. The acceptance criterion is likely successful visualization that meets a standard for medical markers (e.g., clear, distinct signal/contrast).
• Biocompatibility: The materials of the device must be biocompatible according to ISO 10993 standards, and endotoxin levels must be acceptable. The acceptance criteria here would be passing the specified ISO tests and meeting endotoxin limits.

The "study" or "testing" proving these criteria are met consists of the aforementioned structural, functional, visualization, and biocompatibility tests. The document states these tests were performed and implies the device met the necessary standards for substantial equivalence to predicates.

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