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The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

The SecurMark Biopsy Site Markers provide the user with the ability to mark the location of the cavity where a breast biopsy was performed. Radiographic marking allows physicians to locate biopsy cavities should a follow-up lumpectomy or re-biopsy be necessary. The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, permanent biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and a deployment device. The deployment device consists of a rigid cannula, handle, rigid push rod, spring, and plunger. The marker is located at the distal end of the deployment device. The marker is used in conjunction with a biopsy device. The biopsy devices available for use with the SecurMark markers are offered in different needle gauge sizes and lengths. In order to be compatible with their respective biopsy devices, the biopsy site marker deployment devices may be available in multiple size offerings. The hand-held deployment device is utilized for both introducing the marker into the breast and depositing the marker into the biopsy cavity. The deployment device is manually operated and has limited contact with the patient. After the physician has appropriately positioned the deployment device, the physician manually depresses the plunger of the deployment device to deposit the marker in the intended location. The permanent marking components of the SecurMark Biopsy Site Markers are available in different geometric shapes. In the event that two or more biopsy sites need to be marked, the user has the option to use a different shape of marker in each biopsy location. Each marker shape can be discerned under stereotactic (x-ray) imaging. The permanent markers are classified as magnetic resonance (MRI) conditional at 3.0 Tesla field strength or less. The marker, when present in a patient undergoing an MRI procedure at 3.0 Tesla or less, will not create an additional hazard or risk with respect to magnetic field-related interactions, movement/dislodgement or heating.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "X-ray testing" and "Hologic biopsy devices tested with multiple introducer (coaxial) devices" but does not quantify the number of markers, devices, or tests performed for the verification activities.
   • Data Provenance: Not explicitly stated. Given it's a 510(k) submission from Hologic, Inc. (Indianapolis, IN), the testing was likely conducted internally or by a contracted lab within the USA. The document does not specify if the data was retrospective or prospective.

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

   • Not explicitly stated. The document mentions "X-ray testing" for marker discernibility, which implies expert review, but it doesn't specify the number or qualifications of the individuals involved in this assessment. For the geometric compatibility and deployment tests, it seems to be an engineering/technical assessment rather than expert clinical evaluation.

3. Adjudication method for the test set:

   • Not explicitly stated. Given the nature of the tests ("X-ray testing," "Simulated use," "Tolerance analysis"), it's likely that acceptance was determined by meeting predefined technical specifications rather than through a formal multi-reader adjudication process.

4. 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 MRMC comparative effectiveness study was done. This device is a physical medical device (implantable clip and deployment system) and not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

5. 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.

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

   • For marker discernibility: The ground truth would be based on the objective visibility and distinctiveness of the marker shapes in X-ray images, likely evaluated against predefined criteria by qualified individuals (though not explicitly detailed).
   • For deployment and compatibility: The ground truth was based on successful mechanical operation, appropriate fit, and deployment as designed, evaluated through simulated use and tolerance analysis. This is a functional and engineering ground truth.

7. The sample size for the training set:

   • Not applicable. This is a modification to an existing physical medical device, not an algorithm that requires a training set in the machine learning sense. The "training" in this context would refer to internal design, development, and testing processes.

8. How the ground truth for the training set was established:

   • Not applicable as it's not an algorithmic device with a training set. The design and manufacturing processes follow established medical device quality systems, and "ground truth" for components would be established through engineering specifications, material testing, and manufacturing quality control.

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