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

The Endoscopic Applicator is a sterile, single-use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm (or larger) trocar. The Endoscopic Applicator is designed with a luer connector, which is used for connection to a syringe containing the hemostatic agent. The Endoscopic Applicator system consists of a cannula and stylet. The non-reflective cannula is a composite sheath constructed of PolyMed" (a high strength fiber with ester vinyl resin) with an Acrylonitrile Butadiene Styrene (ABS) over-molded luer lock. The stylet (obturator) consists of a PolyMed® composite rod, an ABS over-molded tip, and an ABS over-molded handle. The 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 looks like a 510(k) premarket notification for a medical device called an "Endoscopic Applicator." The document focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical trial data or performance metrics. As such, much of the requested information about acceptance criteria for AI performance is not present.

However, I can extract the available information regarding non-clinical performance and a general understanding of the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing "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, the specific quantitative acceptance criteria for each test are not provided in this summary. Instead, it lists the types of tests performed.

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

• Sample Size: The document does not specify the exact sample size used for each non-clinical test. It generally refers to "test articles."
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by Micromedics, Inc. or a contracted testing facility (Intertek Testing Services is mentioned as a contact for Micromedics for this submission). There is no mention of country of origin for data in the sense of patient data, as this is a non-clinical submission. The testing would be considered "prospective" in the sense that it was performed specifically for this submission.

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

This information is not applicable. The tests performed are engineering and material science tests, not clinical evaluations requiring expert medical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical engineering tests. The results of these tests (e.g., force required to bend, leak rate) would be objectively measured against pre-defined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This device is an Endoscopic Applicator, and the submission is focused on physical and mechanical properties, not the performance of an AI algorithm that would typically be evaluated with MRMC studies.

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

This information is not applicable. The device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering specifications, international standards (e.g., ISO 594-2 for Luer Lock, ISO 10993-1 for biocompatibility), and internal product design requirements.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI system that requires a "training set."

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

This information is not applicable for the reasons stated above.

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