Search Results

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

Not Found

This document is a 510(k) Premarket Notification for a bone marrow biopsy needle, the "TrapMatic System® Set." It is a regulatory submission to the FDA, not a study report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

The text primarily focuses on:

• Regulatory Information: Applicant details, contact person, submission date, trade name, common name, classification, and product code.
• Indication for Use: "This biopsy instrument is used for drawing of osteomedullary substance and or for expllantation of bone marrow."
• FDA Communication: A letter from the FDA determining substantial equivalence to predicate devices, outlining regulatory requirements, and permitting marketing.

There is no information on:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number/qualifications of experts.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established.

This document is a formal notification for market clearance based on substantial equivalence, not a clinical or performance study report.

Ask a specific question about this device