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The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.

The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series.

In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options;

• a) "SoftFix™ Balloon Fixation Ring" combination
• b) "SoftFix™ Balloon Fixation Cone" combination

Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.

The provided text is a 510(k) Summary for the SoftFix™ Balloon Trocar. It describes non-clinical performance testing but does not contain information about acceptance criteria or studies related to AI/algorithm performance, human reader studies, ground truth establishment, or training set details. Therefore, many of the requested items cannot be answered from the provided document.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for any of the individual non-clinical tests. It only states that "non-clinical testing were conducted."
• There is no information on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This document describes non-clinical performance testing for a medical device (trocar), not an AI/imaging diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation (e.g., radiologists) is not applicable. The ground truth for these physical and functional tests would be based on engineering specifications and direct measurements against those specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/imaging diagnostic device requiring human adjudication of interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device (trocar), not an AI-based diagnostic tool.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the ground truth is based on predefined engineering specifications, industry standards (ISO), and mechanical measurements/simulations.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. This is a physical medical device.

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