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The Acueity Excisor Bioptome is a multiple action biopsy system intended for obtaining a soft tissue breast biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

The Excisor Bioptome is a percutaneous, mechanical coring device utilizing imaging quidance such as ultrasound and X-ray for breast biopsy. The basic structure of the device includes a Motorized Cutter and detachable stainless steel Introducer with aluminum handle or finger piece and aspiration port and a stainless steel trocar.

The provided text describes a 510(k) submission for the Acueity Excisor Bioptome, a breast biopsy device. However, it does not contain details about acceptance criteria, device performance metrics, or study design for clinical or standalone performance evaluation.

The submission states:

• "All necessary testing will be performed on the Exisor Bioptome to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." (Section H)
• The FDA's response confirms substantial equivalence based on the provided information but does not detail the specific tests or results.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The document focuses on the regulatory submission process, intended use, and substantial equivalence to predicate devices (US Biopsy Single Action Bioipsy Device (K954231) and Ethicon Mammotome Hand Held System (K991980)), rather than on detailed performance study results.

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