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The Short 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 Short Introducer Sheath, offered in both 6F and 7F sizes, is a vascular access device consisting of a central lumen, angled side arm extension. and a hemostasis valve. The device is used under identical indications for use as the predicate device, as well other substantially equivalent 510(K) cleared devices.

The provided document is a 510(k) summary for a medical device called the "Short Introducer Sheath." This type of document is for premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.

Therefore, the document does not contain the kind of detailed information typically found in a clinical study report that rigorously tests acceptance criteria for a new AI or diagnostic device. Specifically, it states "Discussion of Clinical Tests Performed: Not Applicable."

As such, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on a study, nor details on sample sizes, ground truth establishment, or multi-reader studies, because these elements are not present in the provided text.

The document discusses non-clinical tests performed to demonstrate substantial equivalence, focusing on material changes from an original device.

Here's a breakdown of what can be extracted or inferred from the document regarding its non-clinical testing and regulatory submission:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in quantifiable terms in the 510(k) summary. It states that "Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers." The reported performance is that "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." This implies the device met the ISO 11070 criteria, but the specific numerical performance metrics are not given.
• Sample Size Used for the Test Set and Data Provenance: Not applicable, as this was non-clinical (bench) testing. The "test set" would refer to the physical units produced for bench testing. The document does not specify the number of units tested, only that testing was "derived from the risk assessment."
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable, as this was non-clinical (bench) testing.
• Adjudication Method for the Test Set: Not applicable, as this was non-clinical (bench) testing.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, explicitly stated "Not Applicable" for clinical tests.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm, and no clinical studies were performed.
• Type of Ground Truth Used: For the non-clinical testing, the "ground truth" would be established by the specifications defined in ISO 11070 for sterile single-use intravascular catheter introducers.
• Sample Size for the Training Set: Not applicable, as this is a physical medical device, not an algorithm.
• How the Ground Truth for the Training Set Was Established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device, not a diagnostic or AI device. It focuses on demonstrating substantial equivalence to an existing device through non-clinical (bench) testing and explicitly states that clinical tests were "Not Applicable." Therefore, the detailed information requested about acceptance criteria, study design, and ground truth for clinical performance is not available in this text.

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