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The ENDOPATH® XCEL® Bladeless Trocar with OPT:VIEW™ Technology 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 ENDOPATH® XCEL® Blunt Tip Trocar with OPTIVIEW™ Technology has application in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.

The ENDOPATH® XCEL® Dilating Tip Trocar with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

The ENDOPATH® XCEL®. Universal Trocar Stability Sleeve with OPTIVIEW™ Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

The ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology are sterile, singlepatient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments ranging from 5 to 12 mm diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal 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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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. The trocars contain OPTIVIEW™ Technology, a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

The provided text describes a 510(k) Premarket Notification for the ENDOPATH® XCEL® Trocars with OPTIVIEW™ Technology. This submission is focused on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical studies involving human or animal subjects for primary performance evaluation. Therefore, many of the typical acceptance criteria and study components related to AI/ML or diagnostic device performance are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Bench testing was performed to demonstrate that the device performs as intended and is substantially equivalent to the predicate device, ENDOPATH® XCEL® Trocars." The listed performance data points are comparative mechanical and physical property tests rather than clinical outcomes or diagnostic accuracy.

The document does not provide specific quantitative acceptance limits or detailed results for these tests, only a general statement of "demonstrated substantial equivalence."

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

The document states that "Bench testing was performed."

• Sample Size: The specific sample sizes for each bench test are not mentioned in the provided text.
• Data Provenance: The data is from bench testing, meaning tests conducted in a laboratory setting on the physical device. It is not from human or animal subjects. The location of the testing is not specified, but it would have been conducted by or for Ethicon Endo-Surgery, LLC. There's no indication of retrospective or prospective data as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a physical device (trocar) and the evaluation is based on mechanical performance and physical properties, not diagnostic accuracy or interpretation by experts. Ground truth in this context would be defined by engineering specifications and measurements, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not Applicable. Since the evaluation is based on objective bench test measurements and engineering criteria, there is no need for an adjudication method typically used for subjective assessments or discrepancy resolution in clinical or diagnostic studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is typically performed for diagnostic devices, especially those involving image interpretation, to assess how reader performance changes with or without AI assistance. This device is a surgical instrument, and its evaluation did not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical surgical instrument and does not involve an algorithm or AI component that would have standalone performance.

7. The Type of Ground Truth Used

The ground truth for the bench testing would be engineering specifications, direct physical measurements, and established testing standards. For example, air leak performance would be measured against defined acceptable leakage rates, and drag force against established thresholds or comparative performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a machine learning algorithm, so there is no training set in the conventional sense.

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

Not Applicable. As there is no training set for an algorithm, this question is not relevant.

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