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The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.

The provided document is a 510(k) premarket notification for the BiomarC Fiducial Marker, an existing device that has undergone modifications. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data for acceptance criteria.

Therefore, the information required to fully answer the request, such as a detailed table of acceptance criteria with reported device performance, sample sizes for test and training sets, specifics on ground truth establishment involving expert consensus, MRMC study results, or standalone algorithm performance, is not present in this submission.

The document states that the "Technological Characteristics and Performance" of the modified device are "equivalent to the predicate devices." This implies that the device is not undergoing a new clinical validation study to establish novel performance metrics but rather confirming that its modified design does not negatively impact existing, previously proven performance.

Here's what can be extracted and inferred based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Based on the nature of a 510(k) for a modified device, the "acceptance criteria" appear to be related to demonstrating the continued equivalence of key characteristics and performance aspects to the predicate devices. The document states:

Notes:

• The reported performance is a declaration of substantial equivalence, not quantitative metrics from a new clinical study.
• The "study that proves the device meets the acceptance criteria" in this context refers to the evaluations performed for the 510(k) submission, confirming that the modifications do not alter the substantial equivalence for these key characteristics. These are likely internal testing activities rather than large-scale clinical trials.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. For a 510(k) of a modified device, the "test set" would primarily refer to engineering and bench testing rather than a clinical dataset.
• Data Provenance: Not specified. Again, likely internal testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not describe the establishment of a "ground truth" using experts for a test set in the context of an AI-driven device or diagnostic study. This approval is for a physical medical device (fiducial marker), not an AI algorithm.

4. Adjudication method for the test set:

• Not applicable, as there's no mention of a clinical test set requiring expert adjudication for ground truth.

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:

• Not applicable. This approval is for a fiducial marker, not an AI-assisted diagnostic or assistive tool.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For a physical device like a fiducial marker, "ground truth" would relate to its physical properties and measurable performance characteristics (e.g., visibility, biocompatibility, MRI compatibility). The "ground truth" for the equivalence claim is the performance data of the predicate devices. The current submission confirms that the modified device's performance matches that established "ground truth" of the predicates.

8. The sample size for the training set:

• Not applicable. There is no AI training set mentioned as this is not an AI device.

9. How the ground truth for the training set was established:

• Not applicable.

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The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.

The provided document is a 510(k) Summary for the BiomarC Fiducial Marker (K132064). This document primarily establishes substantial equivalence of the device to predicate devices and outlines its indications for use and technological characteristics.

Critically, the provided text DOES NOT contain information regarding a study that proves the device meets specific acceptance criteria.

The document states: "A biocompatibility, MR safety / compatibility and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Fiducial Marker, was substantially equivalent to the predicate devices." This indicates that these evaluations were performed, and the results supported substantial equivalence, but the specific acceptance criteria and the detailed performance results are not presented in this summary. It emphasizes "substantial equivalence" rather than a detailed performance study against defined acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's what can be inferred/noted based on the provided text, and what cannot be provided:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not list specific acceptance criteria or detailed performance data from a study. It only mentions that certain evaluations (biocompatibility, MR safety/compatibility, sterilization, packaging/shelf life) were performed and supported substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. The document does not describe a clinical or performance study with a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. This information pertains to a study with a ground truth, which is not detailed in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. This information is relevant to a study with multiple readers and ground truth establishment, which is not described.

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:

• Cannot be provided. The device is a physical medical device (fiducial marker), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed/described.

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

• Cannot be provided. The device is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be provided. This information pertains to a study with a ground truth, which is not detailed in the provided text.

8. The sample size for the training set:

• Cannot be provided. The document describes a physical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

• Cannot be provided. Not applicable for this type of device.

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The Biomac Fiducial Marker is indicated for use to radiographically mark soft tissue for future surgical procedures.

The BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, carbon/metallic composite discrete marker that is visible on standard radiographs and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible delivery devices chosen by the user.

This document is a 510(k) Pre-market Notification Summary for the BiomarC Fiducial Marker. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical efficacy claim. Therefore, much of the requested information regarding clinical study design and results is NOT applicable or available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for a study proving clinical efficacy (e.g., sensitivity, specificity, accuracy for a detection algorithm). Instead, the "performance" discussed relates to a qualitative assessment of technological characteristics and safety.

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

Not applicable. The document describes a substantial equivalence submission, not a study with a test set of patient data to assess a clinical performance metric. The "evaluations" mentioned are likely preclinical (e.g., material testing, MR compatibility testing) rather than human subject clinical trials.

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

Not applicable. This information is relevant for studies assessing diagnostic accuracy or image interpretation, which is not the primary focus of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This is not an AI-assisted device, nor does the submission describe an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (fiducial marker), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the evaluations performed (biocompatibility, visibility, MR safety, sterilization, packaging), the "ground truth" would likely be based on:

• Biocompatibility: In vitro and/or in vivo testing against established ISO standards and material specifications.
• Visibility: Imaging phantom studies and comparison to predicate device visibility characteristics.
• MR Safety/Compatibility: Testing according to ASTM standards for MR safety (e.g., heating, artifact, force).
• Sterilization and Packaging: Adherence to ISO standards for sterilization and package integrity testing over shelf life.

These are not "clinical ground truths" derived from patient data in the typical sense.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an algorithm being developed.

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

Not applicable.

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The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength.

BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism.

This document describes the BiomarC Fiducial Marker, a device intended for use in stereotactic radiosurgery and radiotherapy target localization. The submission is a 510(k) premarket notification, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies. As such, the information provided focuses on demonstrating equivalence rather than a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device with specific performance metrics beyond what is provided in the substantial equivalence comparison.

Here's an analysis of the provided text in the context of your questions:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the BiomarC Fiducial Marker's performance. Instead, it aims to demonstrate substantial equivalence to predicate devices by comparing their characteristics and showing that the proposed device is just as safe and effective. The "reported device performance" is inferred through this comparison and the various safety and biocompatibility tests.

The closest we get to "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" for the proposed device (BiomarC Fiducial Marker) is that it meets or matches these characteristics.

Summary of the "Study" Proving Equivalence:

The "study" described is a comparison to predicate devices and performance testing (primarily biocompatibility and visualization demonstrations), rather than a clinical trial with specific performance endpoints. The core argument is:

• The BiomarC Fiducial Marker is identical to the BiomarC Tissue Marker (K063193) except for its expanded indications for use.
• The expanded indications are consistent with those of another predicate, the Fiducial Markers (K071614).
• Biocompatibility and performance testing confirms that the BiomarC Fiducial Marker is substantially equivalent to the Fiducial Markers for the expanded indications for use. (This is the key claim for approval).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. A 510(k) submission based on substantial equivalence to existing devices often relies on the established safety and performance of those predicates and standardized lab testing (e.g., ISO 10993 for biocompatibility) rather than new clinical trials with patient test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Given the nature of the submission (demonstrating equivalence through material properties and standard tests), there wouldn't typically be a "test set" with expert adjudicated ground truth in the way one would for diagnostic AI devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. There is no mention of a clinical "test set" requiring adjudication in the document.

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

This information is not applicable. The device is a physical fiducial marker, not an AI or imaging diagnostic software, so MRMC studies or AI assistance metrics are not relevant.

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

This information is not applicable. The device is a physical fiducial marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device is primarily based on:

• Standardized testing methods: Such as ISO 10993 series for biocompatibility, which has established protocols for determining safety.
• Physical properties: Demonstrating visibility on various imaging modalities (x-ray, CT, MRI, ultrasound).
• Predicate device characteristics: The established safety and effectiveness of the legally marketed predicate devices (K071614 and K063193) serve as the "ground truth" for what constitutes acceptable performance and safety for this type of device.

There is no mention of expert consensus, pathology, or outcomes data being used directly for this specific 510(k) submission as a new ground truth.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are likely informed by prior experience with K063193 and general medical device engineering knowledge.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as point 8.

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