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MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

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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.

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The Endoscopic Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissue during an endoscopic procedure.

The Endoscopic Injection Needle consists of a luer lock hub, flexible cannula and retractable stainless steel needle at the distal tip. The hub is designed to accommodate a standard syringe. The device is supplied sterile and is for single patient use.

This document is a 510(k) premarket notification for an Endoscopic Injection Needle. The device is an accessory for endoscopes used to deliver injectable materials into tissue during endoscopic procedures. The notification concludes that the device is substantially equivalent to a predicate device (Carbon Medical Technologies Endoscopic Injection Needle K042615).

Based on the provided information, there is no study proving the device meets specific acceptance criteria in the sense of an effectiveness or performance study with a numerical outcome on efficacy, sensitivity, specificity, etc. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, risk assessment (FMEA), and various validation and testing activities related to manufacturing and safety.

Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission for this particular device. This 510(k) is for a Class II endoscope accessory, and the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy.

However, based on the technological characteristics and performance section, we can infer the "acceptance criteria" and "study" are related to manufacturing, safety, and equivalence to the predicate.

Here's an attempt to answer the questions based on the available information:

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

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "validation" and "testing" (e.g., sterilization validation, functional testing), which would involve samples, but the specific number of units tested is not provided in this summary.
• Data Provenance: Not specified, but likely from in-house lab testing and potentially third-party testing facilities engaged by Carbon Medical Technologies, Inc. It's a technical submission, not a clinical study involving patients, so "country of origin for clinical data" is not relevant here. The studies mentioned (e.g., sterilization, shelf life) are prospective laboratory/engineering studies.

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)

• Not Applicable. This submission does not involve clinical "ground truth" derived from expert interpretation of medical data (like images or pathology). The "ground truth" for these tests are objective measurements and established standards for engineering, manufacturing, and safety (e.g., sterility, material properties, functional integrity).

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

• Not Applicable. This is not a clinical study involving subjective interpretation that would require adjudication. The "tests" are objective and based on established protocols and standards.

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 study is completely irrelevant for this device. This is a physical medical device (an injection needle), not an AI-powered diagnostic or assistive tool.

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

• No. This is not an algorithm or AI device.

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

• For the validation and testing mentioned, the "ground truth" is based on:
  • Established scientific and engineering principles: (e.g., for functional testing, material properties).
  • Regulatory standards and guidelines: (e.g., for sterilization, biocompatibility, EO residuals, packaging).
  • Predicate device characteristics: For demonstrating technological equivalence.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. This is not a machine learning or AI device.

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The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.

The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.

This document is not a study, but rather a 510(k) Premarket Notification for a medical device (BiomarC Coaxial Needle). It doesn't contain information about a clinical study with acceptance criteria and reported device performance in the way a traditional clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, experts, and ground truth are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device's intended performance and how its characteristics are compared to predicate devices, which implicitly serves as the basis for its safety and effectiveness claims for regulatory purposes.

Here's a breakdown of what can and cannot be extracted:

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

This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a clinical study with measured outcomes against predefined thresholds. Instead, it relies on demonstrating that the proposed device has technological characteristics and performance substantially equivalent to legally marketed predicate devices.

The table below summarizes the comparison between the proposed device and its predicates, which serves as the implicit "proof" of meeting performance expectations for substantial equivalence.

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

• Sample Size: Not applicable. This document does not describe a test set or comparative study with specific sample sizes. The submission relies on a comparison of technological characteristics to predicate devices already on the market.
• Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence, not a clinical trial.

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

Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication.

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/software device and no MRMC study was performed or described.

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

Not applicable. This is a physical medical device (coaxial needle), not an algorithm or AI.

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

Not applicable. There was no "ground truth" in the clinical study sense. The "ground truth" for the device's acceptability is its substantial equivalence to legally marketed devices, implying that their established safety and effectiveness applies to the new device given its similar characteristics and intended use.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set."

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

Not applicable. See point 8.

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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 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.

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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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[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of 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) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

This device is a tissue marker, not an AI/ML device, so many of the requested elements pertaining to AI/ML device studies (e.g., test set, training set, ground truth experts, MRMC study, standalone performance) are not applicable or detailed in the provided documents. The provided text outlines a 510(k) summary for a medical device called the "[Trade Name] Preloaded Tissue Marker Device" and its associated FDA clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable in the context of an AI/ML device. For this physical medical device, specific sample sizes for each type of testing (biocompatibility, sterility, etc.) are not provided in the summary. Data provenance is implied to be from laboratory and engineering testing.

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

• Not applicable as this is not an AI/ML device study.

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

• Not applicable as this is not an AI/ML device study.

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, as this is not an AI/ML device.

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

• No, as this is not an AI/ML device. Performance was evaluated for the device itself through various engineering and scientific tests.

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

• For this type of medical device, "ground truth" refers to established scientific and engineering standards and tests. The "ground truth" for the acceptance criteria was based on:
  • Predicate Device Equivalence: The performance and characteristics of the already cleared predicate devices.
  • Standardized Testing: Biocompatibility standards, sterility validation protocols, distribution simulation standards, and shelf life testing protocols.
  • Risk Analysis: Failure Modes and Effects Analysis (FMEA).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.

The provided text is a 510(k) summary for the BiomarC Gold Tissue Marker. It explicitly states that the technological characteristics are equivalent to predicate devices and that "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate devices."

However, the summary does not contain the specific information requested regarding acceptance criteria, reported device performance data, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness or standalone studies.

Therefore, I cannot provide a table of acceptance criteria and device performance, or answer the other specific questions about study details from the provided text. The document indicates that bench testing was performed, but it does not detail the results of that testing.

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