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The Pelican Sling Retractors have applications in a variety of gynecologic, general, urologic, thoracic, colorectal, laparoscopic and endoscopic procedures for the temporary retracting of internal structures such as organs or tissue.

The Pelican Sling Retractors are comprised of a tube with a blunt tip, a flexible polymer mesh, or a flexible polymer film used for the sling, for use during retraction of tissue. The deployment system consists of a dial that when turned deploys or closes the sling portion of the instrument. All sizes have a Blunt tip for ease of insertion, and to protect the end of the instrument during insertion. All Pelican Sling Retractors have a removable sheath that protects the sling portion of the instrument. When the instrument is fully deployed, the sling opening is maintained in an open position by a tube on one side and a metallic band on the other. The size of the sling can be varied by the amount of rotation of the dial during deployment or closing. The smallest instrument has a straight shaft and can be inserted with or without a trocar/cannula used as a conduit for insertion. The larger sizes have both a straight and curved shaft. The straight shaft can be used with the aid of a correctly sized trocar/cannula, whereas the curved can only be used with a correctly sized flexible trocar/cannula.

The provided text pertains to a 510(k) premarket notification for the "Pelican Sling Retractor" and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria. Therefore, most of the requested information cannot be extracted from this document.

The document describes a medical device, a surgical retractor, and its substantial equivalence to predicate devices, focusing on its physical characteristics, materials, and intended use as a traditional medical device, not an AI/ML product.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

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

• Cannot be extracted. The document does not define specific "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device. It discusses the device's functional characteristics and strength, but not in a quantifiable way that would represent acceptance criteria for an AI/ML model.

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

• Cannot be extracted. The document mentions "in vitro and in vivo" testing for the critical functions of the device, but it does not specify sample sizes for these tests, the type of data used (e.g., patient data for an AI model), or the provenance of any data (country, retrospective/prospective).

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)

• Cannot be extracted. This information is irrelevant for a physical surgical retractor device. There is no "ground truth" establishment in the context of an AI/ML model for this type of device.

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

• Cannot be extracted. Adjudication methods are not applicable to the testing described for this physical device.

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

• Cannot be extracted. An MRMC study is relevant for AI/ML diagnostic or interpretive devices involving human readers. This document describes a surgical tool, not an AI/ML system, so such a study would not be performed.

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

• Cannot be extracted. This question is specific to AI algorithms. The device is a physical retractor, not an algorithm.

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

• Cannot be extracted. As mentioned, "ground truth" in the context of AI/ML is not applicable to this device.

8. The sample size for the training set

• Cannot be extracted. There is no AI/ML model described that would require a training set.

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

• Cannot be extracted. There is no AI/ML model described that would require a ground truth for a training set.

Summary of available information related to performance (not AI/ML specific):

The document states:

• "The critical functions of the device have been tested both in vitro and in vivo and the data confirms the safety and effectiveness of the device and that the basic functional characteristics for ergonomics and strength, are substantially equivalent to the predicate devices cited."
• "Device evaluation included flexibility, mechanical strength tests for the sling portion, and shaft along with the deployed size of the slings."
• "Biocompatibility of the Pelican Sling Retractor materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (

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