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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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The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.

The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.

This document describes a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than "prove" performance against acceptance criteria in the manner of a novel device study. Therefore, the questions related to AI studies, multi-reader multi-case studies, and ground truth for training sets are not applicable here.

Here's an analysis based on the provided text, focusing on how the device demonstrates equivalency rather than meeting specific performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K033842 Nubert, and relevant safety and performance standards. The "reported device performance" for the Mediflex 24003-MF is its characteristic comparison to the predicate.

Explanation of "Met" for Sterile Method: While the methods differ (EO vs. Radiation), both achieve the same Sterility Assurance Level (SAL: 10-6), demonstrating functional equivalence for the purpose of sterilization. The submission explicitly states "Sterilization by means of EO by the contract sterilizer assures a sterility assurance level of 10-6."

2. Sample Size for Test Set and Data Provenance

This submission is a 510(k) for substantial equivalence, not a clinical study in the typical sense with a "test set" of patient data. The "tests" performed are bench tests and validations against recognized standards. Therefore, there is no sample size of patient data or data provenance from countries. Instead, tests were conducted on the device components and final product. Specific sample sizes for each bench test (e.g., sterilization validation, biocompatibility) are not detailed in this summary but would be part of the full submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not a study requiring expert ground truth for interpretation of clinical data or images. The "ground truth" for this substantial equivalence is the established performance and safety of the predicate device and compliance with universally recognized standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical data or imaging interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically related to diagnostic devices, particularly those involving human interpretation, sometimes aided by AI. This device is a surgical tool, and such a study is not relevant to its substantial equivalence determination.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

No. This device is a physical surgical tool and does not involve AI algorithms or human-in-the-loop performance in the sense of software-driven decision making.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established by:

• Predicate Device Characteristics: The known design, materials, function, and performance parameters of the legally marketed predicate device (Vernon-Carus Limited, K033842 Nubert).
• Recognized Standards: Compliance with international and national standards for medical device safety, material biocompatibility, sterilization, packaging, and quality systems (e.g., ISO10993-1, ISO11135-1, ISO11607, ISO14971-1). These standards themselves represent a consensus "ground truth" for aspects like sterility assurance levels, biocompatibility, and risk management.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm or AI model development.

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

Not applicable.

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