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The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.

The LiVac Retractor System is a soft silicone ring connected to suction tubing and is designed to maintain apposition between two substantially planar, conformable, solid organ surfaces, most typically the diaphragm and either lobe of liver, or spleen, thereby exposing the organs beneath. The system is comprised of three components: 1.) LiVac Retractor, 2.) LiVac Bevel, and 3.) LiVac Connector. The suction tubing is connected to a sterile suction hose via the connector, which is positioned partially within the abdominal wall. The LiVac Connector can lie alongside a 12-15mm port within the secondary channel of the LiVac Bevel as per Hasson technique, or within a single incision laparoscopic port device.

This document describes results from a 510(k) premarket notification for the LiVac Retractor System. It includes information on performance data, but it does not contain specific acceptance criteria, reported device performance metrics in a table format, nor details about sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device meets acceptance criteria.

The document states: "LiVac completed a number of tests on their device to demonstrate that it meets all design requirements for performance characteristics, biocompatibility, sterilization, shelf-life and risk. The LiVac Retractor System passed all testing in accordance with internal LiVac performance testing, as well as those international standards shown below to support substantial equivalence of the subject device."

However, the specific "design requirements for performance characteristics" that would serve as acceptance criteria are not explicitly detailed with quantitative targets. Instead, a series of "Pass" results are listed for functional performance, biocompatibility, sterilization, packaging/shelf-life, and risk analysis.

Here's an attempt to answer the questions based on the provided text, acknowledging the significant gaps in information for many points:

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

Note: The document only states "Pass" or "objectives were achieved" without providing the specific quantitative criteria that define a "Pass" or what those objectives numerically were.

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

• Bench Performance Data (Test Set): No specific sample sizes for bench tests are provided.
• Animal Studies (Test Set): "three non-clinical studies on pigs" and "A fourth study was conducted by an independent surgeon in Italy." Data provenance: University of Melbourne (Australia), School of Veterinary Science - Animal laboratory, and Italy. These were prospective studies.
• Clinical Study (Test Set): "an open label study of the performance and safety of the LiVac Retractor in laparoscopic surgery at two hospitals in Victoria, Australia." This was a prospective study. No specific number of patients (sample size) is provided for the clinical study.

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)

• Bench/Animal Studies: Not applicable in the context of expert ground truth. Performance was evaluated through direct observation and measurement in these studies.
• Clinical Study: The study was open label, and both performance and safety objectives were evaluated. While presumably surgeons were involved in assessing performance and safety, the document does not specify the number or qualifications of experts used to establish any formal "ground truth" or expert consensus in the typical sense for a diagnostic device. The outcomes were likely observed and recorded by the surgical team and researchers.

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

• Bench/Animal Studies: Not applicable.
• Clinical Study: The document does not provide any information regarding an adjudication method.

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

This document describes a medical device (a retractor) and its performance, not an AI or diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers improving with AI assistance is not applicable to this submission.

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

This is for a medical device (retractor), not an algorithm or AI. Therefore, a standalone algorithm-only performance study is not applicable.

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

• Bench Performance: Direct measurement and observation of device function.
• Animal Studies: Direct observation of device use during surgical procedures in animals, and evaluation of surgical outcomes.
• Clinical Study: "Performance and safety of the LiVac Retractor in patients undergoing upper abdominal single or multi-port laparoscopic surgery." The ground truth here would be the observed events and outcomes during surgery, as monitored by the surgical team, and potentially patient follow-up data. This is akin to outcomes data or direct observation of device performance and patient safety.

8. The sample size for the training set

This document does not describe any training set. The studies mentioned are focused on demonstrating the performance and safety of a physical medical device (retractor) through testing, not on training a model.

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

As there is no training set, this question is not applicable.

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