Search Results

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

Not Found

The provided document is a 510(k) summary for a medical device called the "Jamshidi Bone Marrow Biopsy Needle." It pertains to the regulatory clearance of a device, not a study evaluating its performance against specific acceptance criteria. This type of document is about demonstrating substantial equivalence to a predicate device for market approval, rather than reporting on a clinical or technical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it does not contain details about a performance study with such metrics.

The document primarily provides:

• Applicant Information: H.S. Hospital Service S.p.A.
• Contact Person: Mr. Lucio Improta
• Device Name: Jamshidi Bone Marrow Biopsy Needle
• Intended Use: For drawing osteomedullary substance and/or for explantation of bone marrow.
• Regulatory Information: Classification, product codes, and the FDA's clearance letter.

The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a predicate device already legally marketed. This process often involves showing that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It does not typically require the detailed performance study data against pre-defined acceptance criteria as would be found in a clinical trial report or a scientific publication.

Ask a specific question about this device