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The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.

The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the SelectCore™ Variable Throw Biopsy Device, which focuses on establishing substantial equivalence to a predicate device.

Specifically, the "Performance Testing Summary" section (in {1}) states: "Performance testing confirms that the quality of samples obtained with the SelectCore™ Variable Throw Biopsy Device is equivalent to that of the predicate device." However, it does not provide details on:

• Specific acceptance criteria: There are no defined numerical or qualitative targets for device performance.
• The study design: No information is given about how the "quality of samples" was assessed, what metrics were used, or what kind of study was conducted.
• Any of the requested details about sample size, ground truth, expert involvement, or comparative effectiveness.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide the detailed study information. The provided text does not contain this level of detail.

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