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The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.

The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The available model of the Trocar is model CT.

All the trocars have the similar structure. They are composed of cannula, stopcock, trocar cap, and obturator. The trocar cap has a universal seal which accommodates instruments of different diameters. The cannula has a valve which ensures the sealing performance.

The CT trocar consists of an obturator assembly and a cannula assembly. The obturator assembly can be assembled with the cannula assembly by indicator fitting. And Model CT includes CT bladeless trocar, CT optical trocar, and CT bladed trocar.

The provided document details the 510(k) premarket notification for the GTK Trocars, asserting its substantial equivalence to a predicate device. However, the document does not contain an "acceptance criteria" table with specific performance metrics and reported device performance for an AI/ML device. It describes testing for a physical medical device (trocars), focusing on biocompatibility, bench testing, and animal studies.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance for an AI/ML device, nor the specific details about test sets, ground truth establishment, expert qualifications, or MRMC studies that would be relevant to an AI/ML device's evaluation.

The document states:

• No clinical testing was done: "Substantial equivalence does not depend on clinical test data." This means there was no human clinical study performed to evaluate the device.
• Ground Truth for training set: Not applicable as there is no mention of a "training set" or "ground truth" in the context of an AI/ML model. The product is a physical medical device.
• Sample size for training set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical trocar, not an AI-assisted diagnostic tool.

Instead, the document describes the following types of studies:

Non-clinical Testing (Physical Device Testing):

1. Biocompatibility Testing:

   • Tests Conducted: Cytotoxicity, Sensitization & irritation, Acute systemic toxicity, Pyrogen test, Endotoxin Test.
   • Standards Conformed: ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
   • Ground Truth: These tests are based on established biological and chemical standards and reactions, not expert consensus on images or data.

2. Bench Testing:

   • Tests Conducted: Appearance, Dimensions, Endoscope visualization image quality, Obturator compatibility, Insertion & Cannula stability, Insertion force & Removal force, Penetration force, Leak rate.
   • Ground Truth: These are engineering and performance validation tests against design specifications and industry standards for physical device functionality.

3. Animal Study:

   • Purpose: To demonstrate operational performance.
   • Performance Criteria Assessed:
     • Ability to access abdominal cavity
     • Ability to maintain Pneumoperitoneum
     • Ability to manipulate instruments for laparoscopic surgery
   • Ground Truth: Based on observed functional performance in an animal model by trained professionals, adhering to veterinary and surgical best practices.

Summary of what is possible to provide based on the document:

• Type of Ground Truth Used: For biocompatibility, it's based on established ISO standards for biological evaluation. For bench testing, it's based on design specifications and engineering standards. For the animal study, it's based on observed functional performance in an animal model.
• Standalone Performance: The non-clinical tests (biocompatibility, bench, animal study) represent the standalone performance evaluation of the physical device. The document does not describe performance against a specific numerical acceptance criterion in the format of AI/ML metrics (e.g., sensitivity, specificity, AUC).
• Sample Size / Data Provenance / Experts / Adjudication: These details are not provided in the context of the physical device testing, as they are often more relevant for clinical trials or AI/ML evaluations. "Sample size" for physical device testing typically refers to the number of units tested, which is not specified but implied by the successful completion of the tests.

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