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The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Gold Anchor™ marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest.

The Gold Anchor™ Introducer ("Introducer") is delivered pre-loaded with the Gold Anchor™ marker inside. It comes in a blister single pack, sterilized, ready for use. The Introducer is used to transfer the marker over into a 22 gauge endoscopic ultrasound aspiration needle ("22G EUS Needle").

Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

This document describes a 510(k) premarket notification for the "Gold Anchor™" device, a fiducial marker used to radiographically mark soft tissue for future therapeutic procedures. The submission states that the device is substantially equivalent to a previously cleared predicate device (K201117). The key difference in the subject device is that the Gold Anchor™ marker comes preloaded in an "Introducer" for transfer into a 22G EUS Needle, whereas the predicate device's marker was preloaded in a needle used directly for implantation.

The submission focuses on the differences between the subject device and the predicate device, specifically regarding the introduction mechanism. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to evaluating the performance of this new Introducer component.

Here's the breakdown of the requested information based on the provided text:

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)

The document does not specify exact sample sizes for the bench testing or simulated use testing. It only states that these tests were "completed." The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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 in the document. Given that the testing was "non-clinical performance bench testing and simulated use testing," it's unlikely that "experts" in the clinical sense were establishing ground truth for the Introducer's transfer mechanism. These types of tests typically rely on engineering specifications and direct measurement/observation.

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

The document does not describe any adjudication method. This type of method is usually relevant for clinical studies with human assessors, which is not what is solely described here for the "Introducer."

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 such study was conducted or mentioned. The device, Gold Anchor™, is a fiducial marker, not an AI-powered diagnostic or assistive tool for human readers. The change being reviewed is a physical component (Introducer) for delivering the marker.

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

This is not applicable. The Gold Anchor™ is a physical medical device, not an algorithm.

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

For the Introducer itself, the "ground truth" would likely be engineering specifications, physical measurements, and observational data during the simulated use testing to verify successful and easy transfer of the marker into a 22G EUS Needle. The document does not explicitly state the specific types of "ground truth" (e.g., specific dimensions, forces, successful deployment rates).

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

This FDA 510(k) summary describes a new version of the Gold Anchor™ fiducial marker, K201117, which is a modification of a previously cleared device, Gold Anchor™, K160209. The primary change is an increase in the iron content of the marker material to enhance visibility on MRI.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The submission does not provide specific, quantifiable acceptance criteria in a tabular format as would typically be seen for a performance study. Instead, it relies on a comparison to established standards and the predicate device.

• ASTM F2052-15: Measurement of Magnetically Induced Displacement Force
• ASTM F2182–11a: Measurement of Radio Frequency Induced Heating
• ASTM F2119-07: Evaluation of MR Image Artifacts
• ASTM F2213-17: Measurement of Magnetically Induced Torque
  Performance Claim: The submission implies that the device successfully met the requirements of these ASTM standards, indicating its safety and compatibility within the MR environment. The specific numerical thresholds or "pass/fail" results are not detailed, but the conclusion states "The subject device can, however, be better visualized on MRI." |
  | Biocompatibility | Conducted Evaluation:
• Evaluation in accordance with FDA guidance "Use of International Standard ISO-10993..." and ISO 10993-1.
• Evaluation based on a chemical characterization risk assessment in accordance with ISO 10993-17 and ISO 10993-18.
  Performance Claim: The submission implies that the device successfully met biocompatibility requirements based on these evaluations. Specific metrics or results are not detailed. |
  | Substantial Equivalence to Predicate | Performance Claim: "The changes between the predicate device and the new device do not affect the intended use in terms of safety and effectiveness." and "The subject device is as safe, as effective, and performs as well as or better than the predicate device." |

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

The document does not explicitly state the sample size used for the tests. It refers to "tests were conducted" without specifying the number of samples (e.g., individual markers) subjected to each ASTM standard test. Since the tests are primarily mechanical, thermal, and imaging artifact assessments, sample sizes are typically determined by the particular ASTM standard recommendations. The document also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to the type of studies conducted. The studies mentioned (ASTM standards and biocompatibility risk assessment) do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic image analysis algorithm would require. They are objective, physical, and chemical evaluations.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. There wasn't an "adjudication" process for establishing ground truth in these types of physical performance and biocompatibility studies.

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

There was no MRMC comparative effectiveness study done, as this device is a physical fiducial marker and not an AI-powered diagnostic or assistive tool. The "better visualized on MRI" claim refers to the physical properties of the marker itself, not its impact on human reader performance with AI assistance.

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

This is not applicable as the device is a physical marker, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. The "ground truth" for the performance of this device is its adherence to universally accepted physical, mechanical, and safety standards (ASTM for MR compatibility, ISO 10993 for biocompatibility). The "truth" is whether it passed these objective tests.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

This is not applicable as there is no training set for this device.

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The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

I'm sorry, but the provided text does not contain the specific information required to answer your request. The document is an FDA 510(k) summary for a medical device (Gold Anchor), which focuses on demonstrating substantial equivalence to a predicate device. It details the device's description, indications for use, comparison to predicate devices, and performance data related to MRI safety and biocompatibility.

The text does not include:

• A table of acceptance criteria and reported device performance in the context of clinical or diagnostic accuracy.
• Details about a study proving the device meets acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
• Information on sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for diagnostic performance. The performance data mentioned is related to MRI compatibility and biocompatibility, not clinical accuracy as would be relevant for AI/diagnostic devices.
• Training set details.

This document describes a passive fiducial marker, not an AI-powered diagnostic device, so the requested information about diagnostic performance, AI studies, and ground truth establishment is not applicable to the content provided.

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Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

The Gold Anchor Marker consists of a thin gold wire with cutouts delivered in a fine needle. The Gold Anchor Marker is available pre-loaded in two different sizes of fine needles: Gold Anchor 120 comes in a 0.53 mm x 120 mm (25 G x 4 3/4") fine needle with an attached injector, and Gold Anchor 200 comes in a 0.7mm x 203mm (22G x 8") fine needle. The Gold Anchor comes in blister single packs, sterilized, ready for use, in lengths of 1-5cm, clearly indicated on the package. They shall be implanted under guidance of ultrasound or CT or during manual palpation of the tumor. The Gold Anchor Marker can be inserted in the tissue in two ways, either through advancing the stylet or by withdrawing the needle. If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes. By withdrawing the needle the Gold Anchor Marker will be deposited as a straight line in the needle track.

This 510(k) submission (K091645) from Naslund Medical AB for the "Gold Anchor" device does not contain a study section that describes acceptance criteria and proves the device meets them with performance data.

Instead, this submission is a Traditional 510(k) submission based on substantial equivalence to a predicate device.

Here's why the requested information cannot be found in the provided text:

• No Clinical Information: The document explicitly states: "Does the submission include clinical information? No". This indicates that no clinical studies were performed or submitted.
• Focus on Substantial Equivalence: The bulk of the information in sections 8.1-8.7 is dedicated to comparing the Gold Anchor to its predicate device (Preloaded RadioMed Soft Tissue Marker, K070305) to demonstrate substantial equivalence based on design, materials, intended use, and general performance characteristics, rather than presenting original performance data against specific acceptance criteria.
• "Performance: Same as predicate device": In section 8.5, under "Scientific technology - Preloaded RadioMed Soft Tissue Marker", it states "Performance: Same as predicate device". This further confirms that no new performance data is being presented, but rather the performance is assumed to be equivalent to the predicate.
• "No change in scientific technology": The comparative tables repeatedly assert "No Change in scientific technology" for various characteristics, implying that the device's fundamental function and resultant performance are not expected to differ significantly from the predicate.

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication, MRMC, standalone studies, and training set details) is not available in this 510(k) submission.

The FDA's clearance letter (pages 5-7) confirms that the device was deemed substantially equivalent based on the provided information, which primarily focused on the comparison to the predicate device to establish safety and effectiveness.

To directly answer the prompt's requirements based on the provided text, I must state that the information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on establishing substantial equivalence to a predicate device, assuming similar performance.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data is presented.
4. Adjudication method for the test set: Not applicable, as no test set data is presented.
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 device is a passive marking device, not an AI-assisted diagnostic or therapeutic system. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance data based on ground truth is presented.
8. The sample size for the training set: Not applicable, as no training set for an algorithm is used.
9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is used.

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