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The Anchorage™ Access Kit facilitates percutaneous access in order to establish a guide through which surgical instruments or devices can be intubated.

The Anchorage Access Kit is a system of components used to gain percutaneous access and provide a conduit for the Anchorage Closure Device (K073096) or other surgical instruments.

The provided text is a 510(k) summary for the Epitek Anchorage™ Access Kit. This type of document is used for regulatory submission and typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner requested for AI/ML devices.

Therefore, the information required to populate the acceptance criteria and study details is not available in the provided text. The document states:

"Results of the in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards conducted prior to introduction into commerce demonstrate that the Anchorage Access Kit is substantially equivalent to the specified predicate device."

This statement confirms that testing was done, but it does not provide details on:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
• Reported device performance against such criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone performance.
• Type of ground truth used.
• How ground truth was established for training or testing.

This information is typically found in clinical study reports or detailed performance verification documents, which are not part of this 510(k) summary.

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