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to be used for histological biopsy on soft tissues. to retrieve bone marrow and bone samples from illac crest. to retrieve bone marrow and bone samples from iliac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues. histological biopsy on soft tissues. aspiration bone marrow from sternum or illac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological and cytological biopsies of soft tissue Aspiration needle for cyto - histological biopsies on soft tissue. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues

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This document is a 510(k) premarket notification for the "Medax Biopsy System - Guns and Needles" and related devices. It is largely a regulatory approval letter and a list of intended uses for various biopsy devices.

Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Specifically, the requested information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this regulatory notice.

The document primarily focuses on:

• The FDA's decision that the device is "substantially equivalent" to predicate devices.
• Regulatory requirements and contact information.
• A list of various Medax biopsy device names and their intended uses (e.g., "histological biopsy on soft tissues," "retrieve bone marrow and bone samples").

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report.

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