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The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The ContainOR device consists of two main components:

• A laparoscopic multi-instrument port .
• Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.

Here's a breakdown of the acceptance criteria and the studies conducted for the ContainOR device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Special Controls" section and the results reported in the "Design Verification" table and "Immersion Testing" section. Due to the nature of the device (a containment system), many acceptance criteria are "Pass" for integrity or functionality. Quantitative criteria are present for immersion testing, shelf life, and some simulated use cases.

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

Due to the nature of the device and the studies, "test sets" often refer to multiple samples of the physical device or simulated procedures.

• Filter Testing (Impermeability to bacteria):
  • Initial: 25 samples of pouch material.
  • After accelerated aging: 32 test samples (and 1 control).
• Immersion Testing (Pouch Integrity Post-Morcellation):
  • Initial: 25 samples.
  • First Morcellation Test Group: 22 test samples (35 initially, 6 excluded for initial leak, 4 excluded for aberrant bacteria).
  • Second Morcellation Test Group (Revised Protocol): 10 test samples (24 initially, 3 excluded for initial leak, 6 excluded for contamination, 2 excluded for leak post-incubation).
  • Total for analysis: 32 test samples.
• Shelf Life Testing:
  • Visual Inspection & Bubble Leak: 15 samples.
  • Seal Strength: 60 samples.
  • Device Functionality (simulated use): 35 samples.
• Preliminary Bench Testing:
  • Laparoscope puncture: 30 test samples.
  • Tenaculum damage: 5 different tenacula, each with 30 material samples (150 total).
  • Powered Morcellation (contact with liner): 5 morcellators, used once each.
  • Pressure/Burst Testing: 30 ContainOR system samples.
  • Obstruction Testing: 30 samples.
• Design Verification (Table 1): Each of the 9 separate tests included 30 or more device samples.
• Clinical Simulation of Morcellation (Animal tissue in SSTR): 34 ContainOR pouches, 5 ContainOR system valve assembly and retractors.
• Additional Testing to Support Use with Stones:
  • Stone validation: Not specified, but involved urologists.
  • ContainOR performance with stones: Not specified, but involved porcine kidneys in a simulator.
  • Surgeon training with stones: 5 general surgeons.
• Animal Model (Training Validation): 34 participants, total of 102 ContainOR systems used.
• Animal Model (Design Validation): 31 participants, 31 ContainOR systems used.

Data Provenance: All data appears to be from in-house studies conducted by the manufacturer, within a controlled laboratory or simulated environment, and an animal model. The country of origin for the device contact is Ireland, implying studies were likely conducted either there or at a contract research organization. The studies are prospective in nature, as they are designed to test the device's performance against pre-defined criteria.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Experts for Stone Simulant Validation: Two urologists. Their specific qualifications (e.g., years of experience) are not detailed beyond "urologists." They confirmed that simulant stones accurately mimicked actual kidney stones.
• Experts for Animal Model Training and Design Validation:
  • Training Validation: 34 participants with a range of experience in laparoscopic procedures. "Experienced" was defined as having previously performed at least 5 power morcellation procedures. "Inexperienced" was the remainder.
  • Design Validation: 31 participants (from the training validation study, minus 3 inexperienced subjects), same qualification breakdown.
  • Additional Training with Stones: 5 general surgeons. Their specific experience level is not detailed, but they successfully completed validated training for the PneumoLiner and proposed ContainOR IFU.

For most bench and simulated use tests (like impermeability, leakage, strength, setup times), the "ground truth" is established by direct measurement or observation of the physical properties and performance of the device against engineering specifications, rather than expert consensus on an interpretation of data.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints, especially when interpreting subjective data (e.g., image reads). For the ContainOR device, which is evaluated primarily through objective performance metrics (leakage, strength, setup times, successful operation), such formal adjudication methods are not explicitly mentioned or typically necessary.

• Leakage Tests (Immersion, Animal Model): The presence or absence of a leak was determined by inspection (e.g., visual check for water/bacterial growth). This is a binary, objective outcome.
• Design Verification Tests: "Pass" results are based on meeting pre-defined quantitative or qualitative engineering criteria.
• User Performance (Animal Model): Success was judged by the participant's ability to "successfully set up and use the ContainOR system" and the subsequent "no leaks" observation, confirmed by a test coordinator.

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

No MRMC comparative effectiveness study was done for this device. This type of study is more common for diagnostic imaging AI algorithms where the question is how AI assistance changes human reader performance in making diagnoses. The ContainOR is a surgical containment device, and its evaluation focuses on its physical and functional integrity, and the ability of surgeons to effectively use it, rather than interpret data.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The ContainOR is a physical medical device, not an AI algorithm. Its performance is always evaluated "standalone" in the sense that its intrinsic properties are being tested (e.g., material strength, impermeability), or its use standalone by a human surgeon (without other AI assisting the surgeon during the procedure being evaluated).

7. Type of Ground Truth Used

The ground truth for most of the studies is based on:

• Direct Physical Measurement/Observation: For strength, leakage, impermeability to bacteria, setup times, flow rates, and visual inspection criteria.
• Engineering Specifications/Acceptance Criteria: For quantitative and qualitative "Pass/Fail" determinations in design verification.
• Expert Consensus (Limited): Two urologists provided consensus on the accuracy of stone simulants.
• Performance Outcome: Successful completion of a surgical procedure in a simulated or animal model, determined by the absence of leaks in the device and the ability of users to follow instructions.

8. Sample Size for the Training Set

The concept of a "training set" as understood in AI (data used to train a machine learning model) does not apply to this physical device.

However, if "training set" refers to the data or procedures used to train human users of the device:

• Training Validation Study: 34 participants were explicitly "trained" in the use of the ContainOR system through a structured program. This involved both assisted and unassisted use in a training rig and a porcine model.

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

Again, this question directly applies to AI/ML context. For the training of human users:

• The "ground truth" for the training program was established by the manufacturer through their validated instructional methods and procedures for the ContainOR system, referencing the Instructions for Use (IFU).
• The effectiveness of this human training was then "validated" by observing whether participants (both experienced and inexperienced) could successfully set up and use the device without compromising its integrity (i.e., without leaks), as determined by objective leak tests conducted by a test coordinator. User feedback also contributed to refining the IFU and training.

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