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The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable device intended for delivering a hemostatic agent to bleeding sites. The Malleable Tip Endoscopic Applicator is the identical to predicate with the addition of a malleable tip at the distal end which allows directional placement of hemostatic agents.

The Malleable Tip Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use. This is the identical packaging configuration as the previously cleared device.

The provided text describes a Special 510(k) Premarket Notification for the Micromedics Malleable Tip Endoscopic Applicator. This submission focuses on design verification and biocompatibility testing for a device that is largely identical to a predicate device, with the addition of a malleable tip.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life." However, specific acceptance criteria values (e.g., "Leakage rate must be less than X mL/min") and the exact results achieved for each test are not provided in this summary. Only the types of tests performed are listed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the non-clinical tests (e.g., number of devices tested for leak testing, kink testing, etc.).
The data provenance is not explicitly stated in terms of country of origin, but the testing was performed by Micromedics, Inc. (a U.S. company). The testing is non-clinical, meaning it was not performed on human subjects and thus the concepts of "retrospective" or "prospective" human data do not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable to this submission. The tests are non-clinical, focusing on mechanical and biological properties of the device. There is no human interpretative "ground truth" established by experts in the context of device performance in these tests.

4. Adjudication Method for the Test Set

This section is not applicable as there were no human-interpreted test results requiring adjudication. The tests were objective measurements against pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on comparing human reader performance, typically in diagnostic imaging, which is not relevant to this device's non-clinical safety and performance evaluation.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an AI/algorithm-based device. The performed studies are standalone in the sense that they evaluate the physical device's performance against specifications, without human interaction with an algorithm.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests are the pre-defined acceptance criteria for each test. For example, a "kink test" would have a predefined acceptable level of deformation or resistance, and the device's performance is measured against that objective standard. For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device's non-clinical evaluation, as it is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as above.

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