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

The SeCurMark family of Tissue Site Marking Systems is composed of two components:

• . an implantable component, composed of a bioabsorbable and permanent component, and
• a deployment device utilized for placement of the implantable component at the site of . interest.
  This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.

The provided text is a 510(k) summary for the SeCurMark Biopsy Site Identification System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study with acceptance criteria and performance metrics typically seen for diagnostic or AI-driven devices.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be found in this document. This filing is about a physical medical device (an implantable clip and its deployment system), not a software or AI-based diagnostic tool.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the device’s efficacy (e.g., accuracy, sensitivity, specificity, or resolution of the marker). The submission focuses on substantial equivalence based on design control processes for safety and effectiveness.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The filing refers generally to "Verification and validation testing" as part of the design control process, but does not specify sample sizes or data provenance for these tests.

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

This information is not provided as there is no mention of a ground truth established by experts in the context of this device's performance given its nature as a physical marker.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an AI or diagnostic imaging device that would involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an algorithm or AI system.

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

The document does not specify a formal "ground truth" in the context of diagnostic accuracy, as it pertains to a physical marker rather than a diagnostic interpretation. The "truth" in this context would likely be related to the physical presence, stability, and visibility of the marker through imaging, which would be assessed through standard engineering and biocompatibility testing, not expert consensus on diagnostic images.

8. The sample size for the training set:

This information is not provided as this is not an AI or machine learning device requiring a training set.

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

This information is not provided as this is not an AI or machine learning device requiring a training set with established ground truth.

Summary of the Study Mentioned (Verification and Validation Testing for Substantial Equivalence):

The document states: "Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use."

• Nature of the "Study": This refers to the overall design control process, which includes various tests (e.g., biocompatibility, sterilization, mechanical testing, visibility under imaging modalities, deployment mechanism functionality). It is not a single, defined clinical study with specific performance metrics and acceptance criteria as one would expect for a diagnostic device.
• Purpose: To demonstrate substantial equivalence to the predicate devices (K062528 in-house and K042296 BiomarC) for regulatory clearance, thereby confirming the device is "safe and effective for use."
• Key Outcome: The FDA reviewed the submission and concurred that the device is substantially equivalent, allowing it to proceed to market. The letter explicitly states there are "No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System."

In essence, the "study" is the entirety of the design control, verification, and validation activities required for medical devices, geared towards proving equivalence to existing legally marketed devices, rather than establishing de novo performance against a defined clinical endpoint with specific statistical acceptance criteria.

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