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Jamshidi Bone Marrow Biopsy/Aspiration Needle – DJ: Intended use for the posterior iliac crest biopsy technique.

Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle - TJ: Intended use for the posterior iliac crest biopsy technique.

Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle – EJ: Indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

The Jamshidi® devices are manual, sterile, disposable needles intended to obtain bone marrow aspirate and core biopsy samples from bone and/or bone marrow. The devices are comprised of an outer cannula with a handle and an inner stylet. Some models include a marrow acquisition cradle (MAC) or a specimen cradle. The MAC and specimen cradle fit inside the cannula to capture and retrieve samples by mechanically cutting the core sample. The specimen is contained within the cradle during withdrawal from the cannula.

The provided document is a 510(k) summary for the Jamshidi Bone Marrow Biopsy/Aspiration Needles. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical performance data.

However, the document states: "N/A - No clinical tests were conducted for this submission".

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria from a clinical perspective, as no clinical studies were performed or reported for this submission. The document focuses on demonstrating substantial equivalence through bench-top testing and simulated use testing, as well as adherence to various standards for risk management, packaging, biocompatibility, and sterilization.

In summary, based on the provided text, there is no information about a clinical study demonstrating the device's performance against clinical acceptance criteria.

The document details non-clinical tests conducted, which are:

• Bench-top testing: Pull testing, sharpness testing (on EJ devices)
• Simulated use testing: (on DJ, TJ, and EJ devices)
• Comparative testing: Sharpness testing, simulated use testing (on JBC devices)

These tests were performed to show that the proposed devices "meet or exceed all performance requirements, and are substantially equivalent to the predicate devices."

Therefore, many of the specific points requested (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) are not applicable or cannot be answered from the provided text as they relate to clinical study design and results, which were not part of this submission.

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