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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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