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The EnCor Enspire™ Breast Biopsy System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.

The EnCor Enspire™ Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected breast abnormalities for diagnostic sampling. The EnCor Enspire™ Breast Biopsy System may be utilized with ultrasound, stereotactic, or MRI imaging guidance during the biopsy procedure. The EnCor Enspire™ Breast Biopsy System may be used with the EnCor™ Probes and EnCor™ Drivers. The EnCor Enspire™ Breast Biopsy System is reusable and provided non-sterile.

The EnCor™ Probe is a handheld biopsy probe used as part of a vacuum-assisted breast biopsy system. The EnCor™ Probe is meant to be used with an EnCor Enspire™ Breast Biopsy System or an EnCor™ Breast Biopsy System. The EnCor™ Probe is provided sterile and is intended for single use.

The EnCor™ Drivers are handheld units for ultrasound quided breast biopsies and for mounting on stereotactic platforms using adapters. The EnCor™ Drivers are reusable and provided nonsterile.

This document does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is an FDA 510(k) clearance letter and summary, which confirms that the device is substantially equivalent to a previously cleared predicate device.

Specifically, the document states:

• "The technological characteristics of the subject device are the same as those of the predicate device."
• "The subject devices and predicate are different in the following manner: Modifications to the Indication for Use Statement."
• "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted."

This clearly indicates that no new performance studies were conducted for this 510(k) submission to demonstrate the device meets acceptance criteria. The clearance is based on the substantial equivalence to the predicate device, and the only change (modifications to the Indications for Use statement) was deemed clerical and not affecting the device's design, safety, or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided FDA clearance documentation.

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