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THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES

Bone Marrow Biopsy Procedure Tray

This FDA 510(k) letter for the "Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray" does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets specific performance metrics.

Here's why and what information is missing:

• Substantial Equivalence (SE) vs. Performance Data: This letter grants "substantial equivalence." This means the FDA has determined the device is as safe and effective as a legally marketed predicate device, not that it has passed specific, quantitative performance acceptance criteria in a study. A 510(k) submission typically relies heavily on comparison to a predicate device, rather than extensive new clinical or performance studies demonstrating novel performance claims.
• Device Type: A bone marrow biopsy tray is a collection of instruments and materials used to obtain a sample. The performance of the tray itself isn't typically measured by statistical metrics like sensitivity or specificity, but rather by its ability to facilitate the procedure (e.g., sterility, strength of components, ease of use, ability to obtain an adequate sample). The diagnostic performance (e.g., accuracy of diagnosis) is related to the subsequent pathological examination of the sample, not the tray itself.

Therefore, I cannot provide the requested information because it is not present in the provided document. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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