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The Bone Injection Gun (B.I.G.) is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

Bone Injection Gun (B.I.G.)

This document is a 510(k) clearance letter from the FDA for the Bone Injection Gun (B.I.G.) device, confirming its substantial equivalence to a legally marketed device. It does not contain information about the device's acceptance criteria, reported performance, or any studies conducted to prove it meets acceptance criteria.

Specifically, the document does not provide any of the following information requested:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

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