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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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The HDR MRI Lumen Marker is indicated as an accessory for use with FDA Market Cleared remote controlled radionuclide applicator systems that are used to treat tumors that are indicated for treatment with high dose rate (HDR) brachytherapy. The HDR MRI Lumen Marker is indicated for temporary placement in HDR applicator lumens.

The HDR MRI Lumen Marker is intended to facilitate the identification of HDR applicator treatment lumens. It is intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen.

Once placed in an HDR applicator lumen the HDR MRI Lumen Marker is intended to be imaged with MRI. It is removed after MR imaging and prior to the placement of a radioactive source. The HDR MRI Lumen Marker is intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient.

The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length.

The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators. Each HDR MRI Lumen Marker is supplied with a silicone stopper designed to hold the device in place once fully inserted into an applicator.

Here's a breakdown of the acceptance criteria and study information for the HDR MRI Lumen Marker, based on the provided FDA 510(k) summary:

The provided document does NOT contain a study with acceptance criteria in the format typically seen for AI/CAD devices, nor does it discuss human reader performance, AI assistance, or standalone algorithm performance.

This device, the HDR MRI Lumen Marker, is a physical accessory used with existing medical equipment. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs similarly and is as safe and effective. It does not involve AI, computer-aided detection (CAD), or complex diagnostic performance metrics that would require the kind of clinical study details you've requested.

The "study" in this context refers to the comparison made for substantial equivalence, which is primarily a comparative analysis of the device's design, materials, and intended use against a legally marketed predicate device.

However, I can extract the information that is present and explain why some of your requested points are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

Since this is a physical accessory and not a diagnostic algorithm, the "acceptance criteria" are related to its physical properties, MRI visibility, and compatibility with existing systems, rather than diagnostic accuracy metrics. The "reported device performance" demonstrates it meets these functional expectations.

Details Not Applicable / Not Provided in the Document:

The following points are typically relevant for AI/Diagnostic imaging devices and are not applicable or not provided in this 510(k) summary for a physical medical device accessory:

2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient data in the sense of a diagnostic classification study. The "testing" would involve physical and imaging compatibility tests, which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established for this device.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done because this is not a diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for this device relates to its physical performance and MRI visibility, confirmed through engineering tests, not clinical diagnostic truth.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for this kind of physical device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Substantial Equivalence Analysis)

The "study" proving the device meets its (implicit) acceptance criteria is the substantial equivalence analysis detailed in Section 02 of the 510(k) summary.

• Comparison to Predicate Device: The HDR MRI Lumen Marker is compared to the Interstitial Ring CT/MR Applicator Set (K091154 Nucletron).
• Key Similarities highlighted:
  • Same intended uses (facilitate identification of lumens in HDR brachytherapy applicators).
  • Same technological characteristics (polymer tube filled with MRI-visible fluid).
  • Both are placed in pre-inserted HDR applicators and imaged with MRI.
  • Neither comes into direct patient contact.
  • Both are removed after MR imaging and before treatment.
• Conclusion: The HDR MRI Lumen Marker is found substantially equivalent to the predicate device, with "no differences that would affect the safety or effectiveness of the proposed device."

In essence, for a device like the HDR MRI Lumen Marker, the "acceptance criteria" are its functional and safety requirements, and the "study" is the demonstration through comparison to a similar, already-cleared device that it meets these requirements and is as safe and effective.

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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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