(30 days)
The Vacora® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling 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 Vacora® Biopsy System is a self-contained, electro-mechanical medical device used to collect breast tissue samples for diagnostic analysis of breast abnormalities. The system is comprised of the non-sterile reusable driver module, and biopsy needle probes, coaxial cannulae/cannula sets and various accessories needed to accomplish a breast tissue biopsy. Most of the accessories are sterile, single use, disposable components of the system.
The provided text describes a 510(k) summary for the Vacora® Vacuum Assisted Biopsy System, focusing on improvements to the 14G Probe. However, it does not contain the specific information requested regarding detailed acceptance criteria, device performance metrics, study design elements (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC or standalone).
The document states:
"The modified Vacora® Biopsy System met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and are substantially equivalent to the unmodified, currently marketed Vacora® Biopsy System."
This indicates that acceptance criteria were established and met, but the document does not elaborate on what those criteria were or how the device performance was measured against them in a quantitative sense relevant to diagnostic accuracy.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document is primarily a regulatory submission summary for substantial equivalence, not a detailed clinical or performance study report.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.