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Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.
It may also be used for the temporary treatment of severely bleeding wounds such as surgical wounds (operative, post operative, donor sites, dermatological, etc.), and traumatic injuries.

Bloxx™ Rapid Clotting Agent is a hemostatic gauze pad treated with cross-linked dextran for the purpose of promoting rapid hemostasis.

I am sorry, but the provided text from the FDA 510(k) letters for the Bloxx™ Rapid Clotting Agent (K061722) does not contain the specific details required to complete your request. The document is an FDA letter confirming substantial equivalence and provides a summary of the device, its indications for use, and mentions that "Laboratory and animal testing using rabbit and porcine models confirms the safety and efficacy of Bloxx™ Rapid Clotting Agent for the local management of bleeding wounds." However, it does not elaborate on:

1. Specific acceptance criteria and reported device performance metrics.
2. Sample sizes used for test sets, data provenance (country of origin, retrospective/prospective).
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory clearance letter, not a detailed study report. Therefore, I cannot generate the requested table and information based solely on the input provided.

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