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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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The Beacon Bag Specimen Retrieval Bag System consists of a family of impervious bags that are sterile, single use, disposable devices having applications as a receptacle for the safe encapture and removal of tissue specimens, organs and calculi during laparoscopic surgical procedures that can be used alone or with a dedicated introducer system.

The Beacon Bag Specimen Retrieval Bags are comprised of an introducer tube with a blunt tip, flexible fiber reinforced plastic bag with a large, easily accessible opening. With the blunt tip the instruments can be introduced percutaneously to the intended surgical site directly through an opening in the abdomen or through a conduit cannula/trocar for sizes under 16 mm, after which the working portion of the instrument can be deployed. The deployment systems consists of either a push/pull rod with thumb ring (similar to a syringe), finger ring handle, or a back handle and a push button with an internal push rod, all instruments have a blunt tip nose used for direct insertion into the abdomen. In the fully deployed condition, the bag opening is maintained in an open position by metallic rings. A suture with a slipknot and perforations of the bag under where the bag is attached to the rings facilitates closure of the specimen bag after the specimen has been collected into the bag, the suture or purse string is connected to an external part (string ring).. The specimen bag has a series of perforations around the perimeter so when the purse string suture is pulled and the bag starts to cinch and separates from the metallic rings, this is accomplished by pulling the external string ring.

The larger sized Beacon Bag Specimen Retrieval Bags, 16mm and 20mm come with a side access tube which allows for additional access into the bag without compromising the integrity of the bag opening to visualize the specimen inside the bag. This is accomplished by using a 5 mm or less sized instruments and scopes to be introduced directly into the bag for additional visualization and manipulation where required.

The provided text describes a 510(k) premarket notification for the Beacon Bag Specimen Retrieval Bag System. This is a medical device clearance document, not a clinical study report for an AI model. Therefore, the document does not contain the information requested regarding acceptance criteria and study proving an AI device meets those criteria.

Specifically, the document discusses:

• Acceptance Criteria for a Physical Device: The document states "The Beacon Bag Specimen Retrieval Bag utilizes technologies that are currently found in legally marketed predicate devices. Based upon testing and comparison with the predicate devices, the Beacon Surgical Specimen retrieval bag system presents no additional adverse indications or results. We have found that the Beacon Bag Specimen Retrieval Bag system does not present any new risks to the patient and that it is safe and performs within its design specifications." This indicates the acceptance criteria are related to safety, performance within design specifications, and equivalence to predicate devices, which are typical for traditional medical devices.
• Study Proving Device Meets Criteria: The document mentions "The devices components being utilized from the predicate device K111845 have been subjected to and passed a variety of bench tests along with sterilization and aging. Additionally, the critical functions of the device have been tested for verification under protocol's BS-0101 and BS-0102 and have met the stated requirements." This refers to bench testing for a physical medical device, not a study involving AI model evaluation.

Therefore, I cannot provide the requested information in the form of the table and the detailed study parameters because the source material does not describe a study related to an AI device's performance against acceptance criteria. The document is for a physical specimen retrieval bag, not an AI or software as a medical device.

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