(106 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 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pertaining to the Introducer: | Non-clinical performance bench testing and simulated use testing were completed. |
| The Introducer will make it easier to transfer the Gold Anchor marker into a 22G EUS Needle. | The subject device "make it easier to transfer the Gold Anchor marker over into a 22G EUS Needle." |
| Maintain safety and effectiveness compared to the predicate device. | "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 (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.
§ 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.