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The Inner-Lock Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.

The Rex Medical, Inner-Lock Introducer Sheaths, 6F and 7F is a vascular access device consisting of a central lumen, an angled side arm extension and a hemostasis valve. The distal tip contains a retention mechanism that is operated via a control arm on the proximal hub. The device is used in exactly the same manner as the predicate device and other substantially equivalent 510(K) cleared devices.

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of specific performance metrics with numerical values, or details about a statistical study demonstrating these criteria were met.

Instead, the document states:

• Acceptance Criteria Derivation: "Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers."
• Testing Performed: "All testing performed on the Inner-Lock Introducer Sheath was derived from the risk assessment which evaluated the effects of the changed materials from the original Inner-Lock Introducer Sheath."
• Biological Evaluation: "All materials used in the Inner-Lock Introducer Sheath were tested according to ISO 10993, Biological Evaluation of Medical Devices."
• Conclusion: "The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness."

Absent from the text is:

1. A specific table of acceptance criteria with numerical targets.
2. Reported device performance data.
3. Details about sample sizes for test sets.
4. Data provenance.
5. Information about experts or ground truth establishment.
6. Adjudication methods.
7. MRMC comparative effectiveness studies.
8. Standalone algorithm performance.
9. Ground truth type.
10. Training set sample size.
11. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing aligned with ISO standards, rather than reporting on a clinical study or specific performance metrics against pre-defined acceptance criteria for, for example, diagnostic accuracy or treatment efficacy.

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