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The FASTI™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

The FASTResponder™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluid to facilitate emergency resuscitation.

The FASTITM and FASTResponder™ Sternal Intraosseous Devices were designed to provide an alternative to intravenous infusion access of the circulatory system. The devices utilize intraosseous infusion to facilitate emergency resuscitation with the use of fluids and drugs. They were designed for use on the manubrium, the upper (superior) portion of the sternum.

The provided text is a 510(k) summary for the Teleflex Medical FAST1™ Intraosseous Infusion System and FASTResponder™ Sternal Intraosseous Device. It is a submission to the FDA for a labeling change to an existing device, not for a new device requiring extensive performance data or clinical trials for substantial equivalence.

Therefore, the document explicitly states: "No performance testing was needed to support this change." (Page 7, Section VII. Performance Data).

This means the document does not contain information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance for such a test.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
6. Standalone performance studies (i.e., algorithm only without human-in-the-loop performance).
7. The type of ground truth used.
8. The sample size for a training set.
9. How the ground truth for a training set was established.

The entire submission is focused on demonstrating substantial equivalence based on the device's technological characteristics remaining unchanged, with the only modification being the addition of contraindications to the product's labeling. The "Performance Data" section explicitly confirms that no new performance testing was conducted or required for this specific 510(k) submission.

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