(293 days)
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm 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 PneumoLiner System consists of two main components:
- A laparoscopic multi-instrument port
- Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue
As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.
The provided text describes the acceptance criteria and performance of the PNEUMOLINER system, but it does not include a study that directly compares human readers with and without AI assistance (a multi-reader multi-case comparative effectiveness study). The device itself is a medical containment system, not an AI-powered diagnostic or assistive tool. Therefore, some of the requested information regarding AI-specific studies will not be present.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details extensive performance testing. Here, we compile a table based on the "Design Verification" section, which includes quantitative acceptance criteria, and other key performance tests.
| Test Category | Specific Test / Performance Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Barrier Testing (Impermeability) | Filter Test (against Brevundimonas diminuta) | Superiority against an 85% rate of passing the leakage test. | 0 failures in 32 samples (accelerated aged). Estimated lower bound for passing leakage test: 0.893 (95% CI). |
| Immersion Test (post-morcellation integrity, against B. diminuta) | Maximum allowable failure rate of 0.125 (12.5%) for detecting superiority against a set failure rate (one-sided significance level of 0.025, 90% power). | 0 failures in 32 samples (first group) + 0 failures in 10 samples (second group) after morcellation. Total 38 samples considered in analysis (out of 59 selected). Upper bound on 95% CI for failure rate: 0.107. | |
| Shelf Life/Sterility | Sterility (SAL) | 10⁻⁶ Sterility Assurance Level | Achieved. |
| Package integrity (visual, bubble leak, seal strength) | Visual inspection per ASTM F1886; Bubble Leak per ASTM F2096; Seal Strength per ASTM F88. | All samples passed. | |
| Device functionality (after accelerated aging, leakage assessment) | Mimics design verification, no leakage. | Tested samples met test acceptance criteria. | |
| Design Verification (Table 1 & footnote) | Test 1: Inspection of Components | Components match color and description, free from damage, no sharp edges, features. | Pass |
| Test 2: Performance and Set-up of Retractor (Incision Opening Maintenance) | Incision remain retracted after 3 hours. | Pass | |
| Test 2: Performance and Set-up of Retractor (Removal Force) | (b) (4) | Pass | |
| Test 2: Performance and Set-up of Retractor (Time to set-up retractor) | (b) (4) | Pass | |
| Test 3: Set-up and Use of Boot Assembly (Leakage rate) | (b) (4) | Pass* (Initial failure related to large instrument passage was resolved with revised design meeting criteria). | |
| Test 4: Set-up and Use of PneumoLiner System (Time to insert) | 0.875. | No leaks observed in 34 PneumoLiner Systems used by participants. Estimated lower bound on 95% CI for leakage: 0.898 (> 0.875). | |
| Design Validation (Porcine Model) | Device integrity (no damage to pouch by surgeons in clinical setting) and Successful use (no leaks) | Lower bound on 95% confidence interval for success > 0.875 (derived from a simple superiority test with 90% power and 0.025 alpha against a 0.875 success limit). | No device failures (leaks) noted in 31 tests. Lower bound on 95% CI for success: 0.889 (> 0.875). |
Note: (b) (4) indicates redacted information, typically quantitative values or specific methods.
2. Sample Size Used for the Test Set and Data Provenance
- Barrier Testing (Filter Test):
- Accelerated Aged: 32 test samples (plus 1 control).
- Provenance: Bench testing, in-vitro.
- Barrier Testing (Immersion Test):
- Initial Group: 22 test samples (from an initial 35, with 6 excluded for initial leaks and 4 for aberrant bacteria).
- Additional Group: 10 test samples (from an initial 24, with 3 excluded for initial leaks and 6 for contamination).
- Total for Analysis: 32 samples (plus controls).
- Provenance: Bench testing, using TSB (Tryptone Soya Broth) and B. diminuta.
- Bench Testing (Preliminary):
- Laparoscope Puncture: 30 test samples.
- Tenaculum Damage: 30 material samples per each of 5 different tenacula.
- Pressure/Burst Testing: 30 PneumoLiner System samples.
- Obstruction Testing: 30 samples.
- Provenance: Bench testing, in-vitro.
- Design Verification (Table 1): Over 30 device samples per test. (Specific counts not always provided but stated as "30 or more").
- Provenance: Bench testing, in-vitro.
- Clinical Simulation of Morcellation: 34 PneumoLiner pouches and 5 PneumoLiner System boot assembly and retractors.
- Provenance: Simulated use in a surgical simulation test rig (SSTR) using animal tissue (lamb heart, beef tongue).
- Training Validation: 34 participants, each using at least 3 PneumoLiner Systems. A total of 102 PneumoLiner Systems were used.
- Provenance: Porcine model (animal study, in-vivo simulation).
- Design Validation: 31 participants, each using one PneumoLiner System.
- Provenance: Porcine model (animal study, in-vivo simulation).
No Human Data: All listed studies are non-clinical (bench or animal models). Therefore, there is no country of origin for human data, as no human data was used directly to support device performance. The studies are prospective in design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is not an AI diagnostic device. Therefore, the concept of "experts establishing ground truth" in the traditional sense of medical image interpretation (e.g., radiologists reviewing images) does not directly apply here.
However, for the Training Validation and Design Validation studies, participants included "surgeons with advanced training in laparoscopic techniques," with varying levels of experience (categorized as "Experienced" and "Inexperienced"). These are the "users" of the device, whose ability to correctly use the device and avoid damage established a form of "ground truth" for usability and safety in a simulated clinical scenario.
- Training Validation: 34 participants (experts/users).
- Design Validation: 31 participants (experts/users).
Their qualifications are described as participants with a "range of experience in laparoscopic procedures," with the device being intended for "surgeons with advanced training in laparoscopic techniques."
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for establishing consensus on ground truth in studies involving expert review of data (e.g., radiology reads). As this is a study about the physical performance and usability of a medical device, such an adjudication method is not applicable.
Instead, the "ground truth" for the performance tests was based on:
- Pre-defined objective criteria (e.g., absence of bacterial growth, lack of leaks, force thresholds, time limits, visual inspection for defects).
- For the simulated use studies (Training and Design Validation), the "ground truth" on successful device use and absence of leaks was assessed by a "test coordinator" or the test team against clearly defined pass/fail criteria (e.g., visual inspection for leaks after a water test).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
MRMC studies typically compare multiple human readers' diagnostic performance on multiple cases, often to evaluate the impact of an AI algorithm on reader accuracy or efficiency. The PNEUMOLINER is a physical medical device, not an AI diagnostic tool, so this type of study is not relevant to its assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an AI algorithm was not done.
This terminology applies to AI algorithms. The PNEUMOLINER is a physical device that requires human operation. Its "standalone" performance is measured through bench testing and simulated use, where the device itself is tested against physical parameters (e.g., impermeability, strength, ability to contain tissue). These tests were conducted without human interaction beyond operating the test equipment or, in simulations, the device itself.
7. The Type of Ground Truth Used
The ground truth used for the various performance tests includes:
- Objective Physical Measurements: Force thresholds, pressure levels, time metrics, visual inspection for damage, dimensional accuracy.
- Biological Impermeability: Absence of bacterial growth (B. diminuta) after challenge.
- Integrity Assessment: Absence of leaks after water filling and visual inspection.
- Usability/Safety: Successful setup and operation of the device by trained users, and absence of device compromise (damage/leakage) in simulated clinical scenarios (porcine models). This is based on observation by test coordinators against predefined success/failure criteria.
8. The Sample Size for the Training Set
The concept of a "training set" typically refers to data used to train machine learning models. As the PNEUMOLINER is a physical medical device and not an AI algorithm, there is no "training set" in this sense.
However, if we interpret "training set" as the data used to inform the design and development of the device (before formal verification/validation), or the data used for the training program for users, then:
- Device Development Data: The document mentions "preliminary tests intended to generate acceptance criteria for their design verification tests as well as to validate the surgical simulator and training rig." These tests (e.g., Laparoscope puncture (30 samples), Tenaculum damage (150 samples), Powered Morcellation (5 samples), Pressure/Burst (30 samples), Obstruction Testing (30 samples)) could be considered analogous to data used in the formative stages.
- User Training Program Data: The "Training Validation" study itself involved 34 participants using a total of 102 PneumoLiner Systems in a porcine model. This study validated the effectiveness of the user training program, which is crucial for the device's safe and effective use.
9. How the Ground Truth for the Training Set Was Established
Again, applying the AI model analogy, there is no "ground truth" for an AI training set here.
If referring to the "Training Validation" study for users:
- The ground truth was established by objective observation of user performance by a study coordinator against predefined criteria for successful setup, use, and removal of the device, as well as post-procedure leak testing of the PneumoLiner pouch. The Instructions for Use (IFU) served as the standard against which user performance was evaluated. The outcome was binary: successful execution of steps and no leaks.
§ 884.4050 Gynecologic laparoscopic power morcellation containment system.
(a)
Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible;
(2) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 ;(3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life;
(4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
(i) Demonstration of the device impermeability to tissue, cells, and fluids;
(ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
(iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
(iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents;
(5) Training must be developed and validated to ensure users can follow the instructions for use; and
(6) Labeling must include the following:
(i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
(ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
(iv) A statement limiting use of device to physicians who have completed the training program; and
(v) An expiration date or shelf life.