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K Number
K031938
Device Name
GEL MARK III BIOPSY SITE MARKER
Manufacturer
SENORX, INC.
Date Cleared
2003-09-05

(74 days)

Product Code
NEU
Regulation Number
878.4300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Gel Mark III is intended to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Device Description

The SenoRx Gel Mark III consists of a disposable applicator containing resorbable pellets. Some pellets contain a wireform, which is intended for long-term marking of the biopsy cavity.

AI/ML Overview

The provided document is a 510(k) summary for the SenoRx Gel Mark III Biopsy Site Marker. It focuses on establishing substantial equivalence to predicate devices for market clearance, rather than presenting a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.

Therefore, the document does not provide the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following information is not present in the provided text:

  1. A table of acceptance criteria and the reported device performance: This document does not establish performance criteria (e.g., in terms of imaging visibility, artifact generation, or long-term visibility) nor does it present a study to measure and report such performance against those criteria.
  2. Sample size used for the test set and the data provenance: No performance study is described; therefore, no test set, sample size, or data provenance is mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
  4. Adjudication method for the test set: Not applicable as no performance study is 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: Not applicable. This device is a physical marker for biopsy sites, not an AI diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
  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 (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance study is described.
  8. The sample size for the training set: Not applicable as no algorithm training is described.
  9. How the ground truth for the training set was established: Not applicable as no algorithm training is described.

The document is a regulatory submission demonstrating that the device is "substantially equivalent" to previously cleared devices based on its intended use, design, construction, marker material, and nominal specifications. It does not detail new performance studies against specific acceptance criteria for diagnostic accuracy or efficacy.

§ 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.