Search Results

The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.

The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).

The provided text is a 510(k) summary for a medical device called the "[Trade Name] Fiducial Marker." However, it does not contain the specific information required to answer questions 1 through 9 about acceptance criteria and the study that proves the device meets them.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, addressing regulatory requirements like biocompatibility, visibility, MR safety, sterilization, and packaging/shelf-life. It mentions that "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced," and that "A biocompatibility, visibility, MR safety / compatibility and sterilization and packaging / shelf-life adoption evaluation confirmed that the modified device, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices." This implies that some testing was done to ensure basic device functionality and safety, but it does not detail a study with the kind of acceptance criteria, test set, ground truth establishment, or multi-reader studies typically associated with validating an AI/ML-based medical device.

Therefore, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies. The document describes a traditional medical device (fiducial marker) clearance process, not one for an AI/ML-driven diagnostic or treatment planning system that would involve such performance metrics validated against a ground truth dataset and human expert comparisons.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed. In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.

The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle. The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.

The provided text describes a 510(k) submission for the ACCUSYTE™ 3D Fiducial Marker, aiming to establish substantial equivalence to predicate devices. The study focuses on demonstrating the device's technical characteristics and performance, particularly its visualization compatibility and MRI safety. However, it does not contain the information needed to fully answer all aspects of your request, especially regarding specific acceptance criteria, detailed study designs for those criteria, or the role of AI.

Here's an analysis of the available information:

This document describes a medical device called the ACCUSYTE™ 3D Fiducial Marker. It is a K180027 510(k) Pre-market Notification from 2018 for a Medical Charged-Particle Radiation Therapy System, and thus the description below is limited purely to the device as presented in the document.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria with specific thresholds for visualization or other performance metrics. Instead, it describes performance data gathered to demonstrate the device's capabilities and substantial equivalence to predicate devices.

• Radiographic Imaging 6-8 weeks after implantation.
• Mammography imaging after 1-year post implantation.

(No specific quantitative clarity metrics or acceptance thresholds are provided, only that it was "clear visualization.") |
| MRI Safety | MR Conditional:

• Static magnetic field of 1.5-Tesla or 3-Tesla.
• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m).
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg in the Normal Operating Mode.
• Expected to produce a maximum temperature rise of ≤2°C after 15-minutes of continuous scanning at 3 Tesla. |
  | MRI Image Artifact | - Image artifact not expected to extend more than 10-mm from the device when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system. |
  | Absorbable Suture Testing| Performed on the Absorbable Suture component (K130735):
• Bacterial Endotoxin (USP Pharmacopeia ) - Pyrogenicity.
• Biocompatibility (ISO-10993) - suture component - Implant.
• Physical Testing - USP 30

Ask a specific question about this device

The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The LumiCoil Platinum Fiducial Marker is a helically wound coil made of a platinum alloy wire. The outer diameter of the coil is 0.46mm. The alloy wire is comprised of ~92% platinum and ~8% tungsten. The LumiCoil Marker is available in two shape configurations: straight and figure 8. The length of the fiducial markers when implanted is 5mm.

The LumiCoil Marker is recommended to be placed using the 22ga Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle.

The provided text describes a 510(k) premarket notification for the LumiCoil Platinum Fiducial Marker, seeking substantial equivalence to predicate devices. It focuses on the device description, indications for use, and technological characteristics, along with a high-level mention of performance data. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details or effect size.
6. Description of standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the following regarding performance:

• "Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the LumiCoil Marker for its indications for use."
• "Comparative testing was performed to demonstrate the visibility of the LumiCoil Marker and the predicate Visicoil Marker."

It does not provide the results of these tests, set specific acceptance criteria, or describe the methodology in a way that allows for answering your detailed questions. This is typical for a 510(k) summary, which provides an overview rather than the full study reports.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The BiomarC Gold 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 Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold 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) summary for the BiomarC Gold Fiducial Marker, which is a device intended for use in stereotactic radiosurgery and radiotherapy. This summary focuses on demonstrating equivalence to predicate devices and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report for an AI/ML-driven diagnostic device.

Therefore, I cannot provide the information requested in your prompt based on the input provided.

The document states:

• "The technological characteristics are equivalent to the predicate devices."
• "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced."
• "A biocompatibility, visibility, and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Gold Fiducial Marker, was substantially equivalent to the predicate devices."

These statements indicate that the evaluation focused on device characteristics and equivalence, not on a detailed performance study with specific metrics as if it were an AI diagnostic tool.

Ask a specific question about this device

The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.

The superDimension superLock Cobra is an implantable marker intended to be used to radiographically mark soft tissue for future surgical or therapeutic purposes. The marker is placed at or near the intended treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is identified with respect to the marker. The superDimension superLock Cobra is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded delivery cartridge. The device is intended for single use.

The provided text is a 510(k) Summary for the superDimension superLock Cobra fiducial marker, alongside an FDA clearance letter and Indications for Use statement. This document describes the device and its intended use, but it is not a study report and therefore does not contain acceptance criteria or detailed study results for performance metrics traditionally associated with AI/algorithm performance studies.

The "Performance Tests" section of the 510(k) Summary states: "Tests were performed to demonstrate substantial equivalence of the superDimension device in comparison to the predicated as follows: • Radiographic Visibility • Compatibility with imaging equipment (Cyberknife, OBI) • Migration resistance."

However, it does not provide quantitative acceptance criteria or reported device performance data for these tests. The document concludes with a general statement: "The results of the nonclinical tests demonstrate that the superDimension superLock Cobra is as safe and effective as the legally marketed predicate devices, and performs as well as or better than the predicate device(s)."

Therefore, I cannot fulfill your request for the specific points regarding acceptance criteria, reported performance, sample sizes, ground truth, or details of an AI/algorithm study because this information is not present in the provided text. The document describes a medical device clearance process based on substantial equivalence to predicate devices, focusing on safety and effectiveness, rather than a performance study of a diagnostic algorithm against specific quantitative metrics.

Ask a specific question about this device

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.

Ask a specific question about this device