(19 days)
The Gel Mark UltraCor Biopsy Site Marker is indicated for use to radiographically mark breast tissue during a percutaneous breast biopsy procedure.
The Gel Mark UltraCor Breast Biopsy Marker consists of a 17 Ga disposable beveled needle Applicator containing: 2 resorbable polylactic acid/polyglycolic acid pellets. 1 gold marker in the center position. 1 polyethylene glycol (PEG) plug in the needle bevel. The gold marker is intended for long-term radiographic marking of the tissue site. The pellets are visible via ultrasound for approximately 4 weeks and are essentially resorbed in approximately 12 weeks. The Applicator has a beveled 20 cm needle with 1 cm depth marks and a locking plunger. The pellets are deployed from the beveled needle tip into the tissue site.
The provided text describes a 510(k) premarket notification for the "Gel Mark UltraCor Biopsy Site Marker." This document focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way one would for a diagnostic AI algorithm.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or extractable from the provided text, as it's a regulatory submission for a medical device (a physical marker) and not a software/AI device.
However, I can extract the relevant information regarding the device itself and its equivalence claim.
Device Description and Equivalence Summary
Device Name: Gel Mark UltraCor Biopsy Site Marker
Indications for Use: To radiographically mark breast tissue during a percutaneous breast biopsy procedure.
Summary of Substantial Equivalence (as presented in the document):
The Gel Mark UltraCor Biopsy Site Marker has the following similarities to the previously cleared predicate devices (Biopsy Site Marker; K011402; and Gel Mark IV Tissue Marker, K040706):
- Same indications for use.
- Same intended treatment site.
- Same operating principle.
- Same basic design.
Preclinical testing (mentioned as the "study" context):
- "Preclinical testing had confirmed the radiographic visibility of the gold marker."
- "Gold, as a long-term implant, has an extensive history of use and has been cleared for use in a similar application."
- "The resorbable polyethylene glycol plug has been used previously in SenoRx biopsy site markers to contain pellets in the applicator."
- "The change to a metallic (stainless steel) applicator shaft is similar to the metallic (titanium) of a previous cleared SenoRx device."
- "The reduction in the applicator shaft diameter varies in a manner that has no impact on device safety."
Given the nature of the document (a 510(k) summary for a physical medical device), a "table of acceptance criteria and reported device performance" in the context of an AI/software device's accuracy or other performance metrics is not provided. The "acceptance criteria" here are implied by the FDA's substantial equivalence pathway, meaning the device must be as safe and effective as a legally marketed predicate device. The "study" referenced is preclinical testing and a comparison to known properties of materials.
Therefore, for the specific questions:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by 510(k) pathway): Substantial equivalence to predicate devices in terms of indications for use, intended treatment site, operating principle, basic design, and safety/effectiveness. Specifically, radiographic visibility of the marker, biocompatibility of implanted materials, and no adverse impact from design changes.
- Reported Device Performance:
- Radiographic visibility of the gold marker confirmed by preclinical testing.
- Gold has an extensive history of safe use as a long-term implant.
- Pellets are visible via ultrasound for approximately 4 weeks and resorbed in approximately 12 weeks.
- Polyethylene glycol plug previously used in SenoRx biopsy site markers.
- Metallic applicator shaft change (stainless steel vs. titanium) deemed to have no impact on device safety.
- Reduction in applicator shaft diameter deemed to have no impact on device safety.
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Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing an algorithm's performance on a dataset. The "test set" would refer to the characteristics and function of the physical device components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to material properties, physical dimensions, and radiographic characteristics, which are standard engineering and material science evaluations, not expert image interpretation.
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Adjudication method: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/software device requiring an MRMC study for reader improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical device, not an algorithm.
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The type of ground truth used: For a physical device, "ground truth" refers to physical properties, material characteristics, and functionality. For example, the ground truth for "radiographic visibility" would be observable evidence on radiographic images. For biocompatibility, it would be established through material testing and historical evidence of use.
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The sample size for the training set: Not applicable. There is no training set as this is not an AI/software device.
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How the ground truth for the training set was established: Not applicable.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.