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The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

This document does not contain any information about an AI/ML device, therefore, an answer to the request cannot be generated. It describes a traditional medical device, the Monik™ - Disposable Endoscopic Trocar, and its substantial equivalence to predicate devices based on design, materials, sterilization, packaging, and performance testing.

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The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.

The provided text describes the acceptance criteria and the results of a study for the Fengh Medical Disposable Endoscopic Trocar.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several "Testing" categories and provides specific criteria along with implied performance (meeting those criteria). However, the "Table 2" under "Substantial Equivalence" merges proposed device characteristics with general requirements. I've extracted the acceptance criteria from the "Testing" section and the detailed comparison table, and for performance, the document generally states that the device is "substantially equivalent" because "testing standards are identical" and "the differences between both devices are insignificant in terms of safety and effectiveness," implying the device met these criteria.

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., Sterility Test, Peel Strength, Biocompatibility tests). It only lists "Testing" categories and the methods.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The document describes non-clinical and biocompatibility tests, which typically rely on standardized laboratory protocols and measurements rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (non-clinical, biocompatibility), adjudication methods common in diagnostic device studies (like 2+1 or 3+1) are not typically applicable.

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

No, an MRMC comparative effectiveness study was not done or reported in this document. The document focuses on performance testing of the device itself against established criteria and comparison to a predicate device based on technological characteristics and intended use.

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

This question is not applicable as the device is a physical medical instrument (trocar) and not an algorithm or AI-based diagnostic tool.

7. Type of Ground Truth Used:

For the non-clinical and biocompatibility tests, the "ground truth" would be objective measurements and adherence to pre-defined physical, chemical, and biological standards (e.g., specific force measurements, absence of microbial growth, absence of toxic reactions). These are not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. Sample Size for the Training Set:

This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.

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

This question is not applicable for the same reason as point 8.

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