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The CONMED OnePort® Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of abdominal entry and access for endoscopic instruments.

The OnePort® Surgical Trocar System is a range of surgical trocars and accessories intended for use as a means of providing abdominal access for various instruments during laparoscopic, and thoracoscopic surgery. The OnePort® Surgical Trocar System is available in four configurations:

• . Fully disposable with Bladed Trocar
• Fully disposable with Dilating Trocar .
• Reposable Cannula with Bladed Trocar (reusable cannula, disposable . trocar and seal)
• Reposable Cannula with Dilating Trocar (reusable cannula & obturator, . disposable seal)
  Each configuration is made available in numerous diameters and lengths with either smooth or ribbed cannula for additional abdominal retention. Reusable cannulae and dilating obturators are supplied non-sterile and must be sterilized prior to use (Refer to "Reprocessing of Multi-use Components" in the Directions for Use). Also, see OnePort® Surgical Trocar System sales literature for a complete list of available sizes.

The provided 510(k) summary is for a medical device called the OnePort® Surgical Trocar System, which is a surgical instrument and not an AI/ML powered device. Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth type, training set size, and ground truth establishment for training set) which are typically relevant for AI/ML device evaluations, are not applicable to this submission.

The summary states:

Acceptance Criteria and Device Performance:

The "Nonclinical Performance" section explicitly states: "The OnePort® Surgical Trocar System was tested and passed all required functional and biocompatibility testing."

No specific acceptance criteria values (e.g., specific thresholds for force, deflection, or biological response) and their corresponding reported device performance values are detailed in this summary. The success is simply stated as having "passed all required testing."

The Study That Proves the Device Meets Acceptance Criteria:

The "Nonclinical Performance" section refers to "required functional and biocompatibility testing." However, no detailed study design, specific test names, methodologies, or results are provided beyond the general statement of passing these tests. This summary does not include the type of detailed information (like sample sizes for test and training sets, data provenance, expert involvement for ground truth, adjudication methods, or MRMC/standalone studies) that would be relevant for an AI/ML powered device or a more detailed performance study submission.

Therefore, since the request is for information related to AI/ML device evaluations and this is a traditional medical device, I cannot fill out the requested table and answer the study-specific questions.

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