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More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.

When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:

• A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).

• B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Impermeability Testing: 36 More-Cell bags (retrospective, samples exposed to 2-years aging and simulated use).
• Mechanical Performance (various tests): 30 samples each (retrospective, samples exposed to 2-years simulated aging, with the exception of rivet testing).
• Animal Performance Testing: 16 animals (8 in test group with More-Cell-System, 8 in control group without). Type of data (retrospective/prospective) is not explicitly stated, but implies prospective due to it being an "in vivo porcine model" with randomized distribution. Country of origin not specified, but usually animal studies are controlled within a specific research facility.
• Clinical Usability Study (outside US): 26 clinical cases involving 26 surgeons. Data provenance: Austria (n=6), Germany (n=19), Switzerland (n=1). This is a prospective observational study.
• Simulated Use Study (US): 11 U.S. surgeons. Data provenance: US. This is a prospective simulated use study.

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

• Impermeability Testing: Not applicable. Ground truth was established by laboratory methods (immersion test with E. coli, positive and negative controls).
• Mechanical Performance: Not applicable. Ground truth was established by engineering specifications and objective measurements (e.g., force, pressure).
• Animal Performance Testing: "Two surgeons" performed the laparoscopic supracervical hysterectomy. Their qualifications are not specified beyond being "surgeons." Ground truth for the presence of disseminated myometrial cells was established by "positive cytology."
• Clinical Usability Study (outside US): 26 surgeons, with "various levels of experience." The "ground truth" here was subjective evaluation by the surgeons themselves (ease of insertion, visualization, etc.), and objective observation by study personnel for leaks and successful completion of procedures.
• Simulated Use Study (US): 11 U.S. surgeons "with a range of laparoscopic surgery experience (2.5 years to 30 years)." Similar to the other usability study, "ground truth" was adherence to critical tasks observed by study personnel, and subjective feedback from participants.

4. Adjudication Method for the Test Set

• Impermeability/Mechanical Testing: No specific human adjudication method mentioned, as these were objective lab tests comparing results against pre-defined acceptance criteria.
• Animal Performance Testing: "Positive cytology" determined disseminated cells. It's not specified if multiple pathologists or a single expert adjudicated the cytology results.
• Clinical Usability Study (outside US) & Simulated Use Study (US): The text mentions that surgeons were "asked to evaluate and record" and participants were "observed to assess adherence to critical tasks." This implies observation by study personnel. There is no explicit mention of an adjudication panel (e.g., 2+1 or 3+1) for discordant observations or evaluations; it appears to be direct observation and feedback.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not performed. This device is a physical medical device (containment system), not an AI/software product, so this type of study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. As mentioned, this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Sterilization: Laboratory testing results (sterility assurance level).
• Shelf Life: Laboratory testing results (visual inspection, dye penetration, peel strength, microbiological stability) and functional testing.
• Biocompatibility: Laboratory testing results (cytotoxicity, sensitization, irritation, acute systemic toxicity).
• Impermeability: Laboratory testing results (E. coli immersion test) and cytology in animal model.
• Mechanical Testing: Engineering specifications and objective measurements (e.g., force, pressure via bench testing).
• Animal Performance: Pathological analysis ("positive cytology") for disseminated cells, and visual examination for bag breach.
• Usability Studies: Observational data on task completion, user feedback, and objective checks for leaks/damage.

8. Sample Size for the Training Set

No "training set" in the context of an AI/ML algorithm is mentioned or applicable here. The device is hardware. The studies described are for validation of the final device.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical device.

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