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The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.

The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar. The device system consists of a Gas Regulator, Foot pedal, Tubing set, Adapter Handle, and FlexiTip XL-R rigid applicator. The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator.

The provided document describes the MEDAFOR DIRECT Gas-Assisted Application System, a medical device designed to assist in the delivery of powdered hemostatic agents during surgical procedures, including endoscopic surgeries.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in a quantified manner. Instead, it lists "Critical Parameters" for mechanical and functionality tests and broadly states, "All tests met acceptance criteria." This indicates that the device successfully passed all established thresholds for these parameters, although the specific thresholds are not provided.

Here's a summary of the critical parameters and the reported performance:

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

The document does not explicitly state the sample sizes for the mechanical and performance tests. For the "System Verification Test in Swine," it implies that animal testing was performed, but neither the number of animals nor the specific provenance (e.g., country of origin) or type (retrospective/prospective) of this data is mentioned.

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

The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily mechanical and functional, suggesting objective measurements against predefined engineering specifications rather than subjective expert assessment. The "System Verification Test in Swine" would likely involve veterinary professionals or surgeons, but their role in establishing "ground truth" and their qualifications are not detailed.

4. Adjudication Method for the Test Set

Since the tests appear to be objective mechanical and functional assessments, an adjudication method (like 2+1 or 3+1 used for expert consensus) is not applicable or mentioned. The results would likely be determined by direct measurement against established engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. The document focuses on demonstrating the device's basic functionality and safety through mechanical and animal testing, and its substantial equivalence to a predicate device, rather than comparing its effectiveness with and without AI assistance for human readers (as the device is not an AI-assisted diagnostic tool).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was done. This device is a mechanical system for delivering a substance, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant to this submission.

7. The Type of Ground Truth Used

For the mechanical and performance tests, the "ground truth" was likely established through:

• Engineering Specifications/Standards: The device's design and performance were measured against predetermined specifications for compatibility, delivery, control, leakage, pressure, and flow.
• Intended Functionality: The "System Verification Test in Swine" aimed to confirm that the device "performs as intended under simulated conditions," implying a ground truth based on the expected outcome of delivering the powdered hemostat.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data in the context of establishing the device's functional integrity.

8. Sample Size for the Training Set

This information is not applicable. The device is a mechanical system, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This information is not applicable. As there is no training set mentioned for an algorithm, there is no ground truth establishment for such a set.

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