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The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.

The Manoa Breast Biopsy System is comprised of a sheath introducer, a tissue cutter, a specimen retriever and an electrosurgical cable. The Manoa Breast Biopsy System is a minimally invasive biopsy device designed to penetrate, cut and collect an intact tissue specimen during a biopsy procedure.

This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in clinical trial reports.

Therefore, the provided text does not contain the detailed information required to fill out the requested table and answer many of the specific questions about acceptance criteria, study design, and performance metrics.

Here's what can be inferred and what is missing based on the provided text:

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Inferred Information (limited):

From the context of a 510(k) submission for an "Electrosurgical Cutting and Coagulation Device and Accessories (Breast Biopsy Device)", the "performance" typically refers to engineering performance, safety, and functionality, rather than diagnostic accuracy or concordance with a clinical ground truth, which would be the focus for an AI/CADe device.

The study that "proves" the device meets acceptance criteria in a 510(k) context usually refers to a battery of tests demonstrating physical, electrical, and biocompatibility safety and performance, as well as functional equivalence to predicate devices. The document explicitly mentions "biosafe materials which are ISO 10993-1 compliant for their intended patient contact profile," which is a statement about materials performance and safety.

Given the information in the provided 510(k) summary, it's not possible to populate the requested table or answer the specific questions about clinical or AI performance. The document focuses on device description, indications for use, predicate devices for substantial equivalence, and regulatory classification.

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