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The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture.

The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of AI/ML, clinical performance, or diagnostic accuracy. Instead, the document is a 510(k) premarket notification for a medical device (EnCor® MRI Introducer Set, EnCor® Probe Introducer) with a summary of changes and performance testing.

The key points from the provided text are:

• Device: EnCor® MRI Introducer Set, EnCor® Probe Introducer.
• Purpose: These devices are used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway for diagnostic biopsy.
• Regulatory Submission: This is a 510(k) submission for a change in the printing ink material used on the outer cannula of the device.
• Predicate Device: SenoRx, Inc. Introducers (K042098).
• Performance Testing Summary (related to the change):
  • Biocompatibility testing of the new ink (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogen Testing).
  • Functional testing after Accelerated Shelf Life and T=0 (Ink adhesion and ink adhesion IPA wiping).
• Conclusion: The testing demonstrated that the technological characteristics and performance criteria of the EnCor® Introducers are comparable to the predicate device, and it performs as safely and effectively.

Based on the nature of the document, which pertains to a minor material change in an accessory device and its substantial equivalence to a predicate, the typical elements you requested (like AI/ML performance, sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable or present.

Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study proving device performance using those criteria, as the document focuses on regulatory approval for an updated component (ink) of a physical medical device, not a diagnostic AI/ML algorithm.

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