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The Single Step™ Biopsy Device System is intended for breast lesion localization and diagnostic tissue sampling for histological 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 Single Step™ Biopsy Device is an electrosurgical cutting instrument which uses radio frequency (RF) energy to localize a breast lesion and cut a sample of breast tissue for diagnostic biopsy.

This 510(k) premarket notification for the SenoRx Single Step™ Biopsy Device System does not contain the detailed study information required to answer the prompt in full.

The document is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an indications for use statement. While it describes the device and its intended use, it does not include the results of specific performance studies against acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes and data provenance, details on experts or ground truth establishment, or any information regarding MRMC studies or standalone algorithm performance.

Here's what can be inferred from the provided text:

• Acceptance Criteria/Study: Not explicitly stated in the provided document. The 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, rather than requiring new clinical trials that establish acceptance criteria and prove performance against them in the same way a PMA would.
• Device Performance: The document states that "The intended use, design, construction, materials and technology are comparable to the predicate devices." This implies that its performance is expected to be similar to legally marketed devices, but no specific performance metrics or acceptance criteria are provided.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: None of this information is available in the provided text. The 510(k) submission process typically focuses on demonstrating equivalence through non-clinical testing (e.g., bench testing, material compatibility) and comparison to predicate device characteristics, rather than extensive clinical efficacy studies with ground truth establishment in the way described in the prompt.

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