(45 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Magnetic Resonance (MR) Environment Compatibility | Conducted Tests: |
- 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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.