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This device is a sterile, single-use device and indicated for use in general, thoracic, gynecologic, or minimally invasive procedures to establish a path of entry for minimally invasive instruments.

The NexPort™ Trocar System is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed devices are available to accommodate 5mm and 10mm surgical instruments.

The 5mm NexPort™ Trocar System is consisted of:

• Obturator Shaft a)
• Cannula Cap b)
• Seal c)
• Duckbill Valve d)
• e) Cannula Body
• f) Luerlock Cap
• g) Obturator Tip Protector
• Cannula Tip Protector h)

The 10mm NexPort™ Trocar System is consisted of:

• a) Obturator Shaft
• Cannula Cap b)
• Seal c)
• Cannula Intermediate Plate d)
• Duckbill Valve e)
• f) Cannula Housing
• Stopcock g)
• Face Seal h)
• i) Cannula Sleeve
• Reducer j)
• Adaptor Cap k)
• I) Adaptor Top Body
• m) Adaptor Seal
• n) Adaptor Bottom Body

This is a 510(k) premarket notification for a medical device called the "NexPort™ Trocar System". This document does not describe a study that uses AI or machine learning. Therefore, most of the requested information regarding acceptance criteria and study design for AI/ML performance evaluation is not available in this document.

However, I can provide the available information related to the device's validation and comparison to predicate devices, as well as the non-clinical tests performed.

Current Device: NexPort™ Trocar System

Summary of Device Validation and Performance (based on provided text):

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a standalone performance study with specific acceptance criteria that would typically be seen for an AI/ML device. The validation involves non-clinical tests and comparison to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it details that the device has undergone various non-clinical tests and has been found to conform to applicable medical device safety standards.

The relevant "performance" is implicitly demonstrated through:

• Identical Intended Use/Indications for Use as predicate devices.
• Identical Principles of Operation as predicate devices.
• Identical Application Sites as predicate devices.
• Identical Single Use nature and Operation Mode (Manually) as predicate devices.
• Identical Sterilization Assurance Level (SAL) ($

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