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The FINESSE™ Ultra Breast Biopsy System is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.

The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The subject device, the FINESSE™ Ultra Breast Biopsy System, is a handheld, self-contained, vacuum assisted breast biopsy system for use with ultrasound imaging guidance. The system is comprised of (1) a reusable hand piece (driver) that contains all electronics and components to generate a vacuum without the need to be connected to any external power supply or vacuum source and (2) a disposable biopsy probe capable of excising and storing multiple tissue samples without the need for the probe to be removed from the patient between samples.

The provided text describes the FINESSE™ Ultra Breast Biopsy System and states that "[t]he FINESSE™ Ultra Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs." However, the document does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, ground truth, expert qualifications, or study types like MRMC comparative effectiveness or standalone performance.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study reports with specific performance metrics and methodologies.

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