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The LapBox Power Tissue Containment System 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 LapBox is compatible with 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. When used in women with fibroids, the LapBox Power Tissue Containment System is for women who are pre-menopausal and under age 50.

The LapBox Power Tissue Containment System is a single use sterile device. It is comprised of a double wall inflatable polyurethane chamber which is mounted on an insertion shaft and is provided with two port sizes. Once the shaft is inserted to the abdominal cavity, the chamber is deployed and the organ to be morcellated is placed within the chamber. The chamber is then inflated using an external handpump and the sleeve of the chamber is exteriorized. The selected port is then placed over the sleeve in the incision site and the organ can be morcellated using a power morcellator. Once morcellation is complete, the port is removed, and the chamber is deflated and removed from the patient.

The provided FDA 510(k) clearance letter describes a medical device, the LapBox Power Tissue Containment System, which falls under the regulation of medical devices, not AI/ML-based software. Therefore, the information typically found in a study proving an AI device meets acceptance criteria (such as sample sizes for training/test sets, expert adjudication, MRMC studies, or specific ground truth methodologies for AI models) is not applicable here.

However, I can extract the acceptance criteria and performance data for the LapBox Power Tissue Containment System based on the non-clinical performance testing described in the document.

Overview of Device and Study Context

The LapBox Power Tissue Containment System is a medical device intended for use during minimally invasive gynecologic laparoscopic surgery to contain and isolate tissue during power morcellation. It is a physical device, not an AI/ML software. The provided document details the non-clinical testing performed to demonstrate its safety and effectiveness for 510(k) clearance, asserting substantial equivalence to a predicate device (PneumoLiner).

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device and not an AI/ML model, the "acceptance criteria" and "device performance" are focused on engineering, biological, and usability metrics rather than AI-specific performance metrics like sensitivity, specificity, or AUC. The document outlines various tests conducted and confirms whether the device met the prespecified acceptance criteria for each test. The actual quantitative "performance" data (e.g., specific burst pressures, detailed force measurements) are generally not fully presented in a 510(k) summary but rather summarized as meeting criteria.

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

As this is a physical device, the "test set" refers to the samples of the device itself and the human users/animals involved in performance testing. There isn't "data provenance" in the sense of patient data for AI.

• Bacterial Immersion Test: 32 device samples. Data provenance: Controlled laboratory test.
• Dimensional Verification Tests (Supplemental): 30 non-aged units. Data provenance: Controlled laboratory test.
• Pressure Relief Valve Testing: 30 aged and 30 non-aged units (total 60). Data provenance: Controlled laboratory test.
• Design and Performance Validation Test: 30 aged and 27 non-aged units (total 57). Data provenance: Simulated environment using bovine tongue.
• Puncturing Force Comparative Test: 72 predicate material samples, 72 aged LapBox material samples, and 72 non-aged LapBox material samples (total 216 material samples). Data provenance: Controlled laboratory test.
• Bond Strength Tests (Supplemental): 30 aged units. Data provenance: Controlled laboratory test.
• Burst Pressure Evaluation (Modified Air Tube): 10 non-aged units. Data provenance: Controlled laboratory test.
• Inflation Pressure Range: One LapBox unit. Data provenance: Controlled laboratory test.
• Comparison Force Test: One predicate device and one LapBox device. Data provenance: Controlled laboratory test.
• Corrosion Resistance (from K221365): 30 units of 2 different metal components (total 60). Data provenance: Controlled laboratory test.
• Burst Pressure Evaluation (from K221365): 30 aged and 30 non-aged units (total 60). Data provenance: Controlled laboratory test.
• Bond Strength Tests (from K221365): 30 non-aged units and 30 aged units (total 60). Data provenance: Controlled laboratory test.
• Dimensional Verification (from K221365): 36 non-aged units. Data provenance: Controlled laboratory test.
• Viral Penetration ASTM Method F 1671 (from K221365): 30 material samples. Data provenance: Controlled laboratory test.
• Maximum Organ Size Testing (from K221365): 2 aged devices. Data provenance: Controlled laboratory test.
• Initial Usability Study: 31 physicians, performing a total of 40 procedures. Data provenance: Simulator with bovine tongue.
• Supplementary Usability Study: 6 physicians, performing a total of 33 procedures. Data provenance: Simulator.
• Training Validation: 16 physicians, completing 32 procedures. Data provenance: Porcine model with bovine tongue.
• Follow-up Usability Study: 15 physicians, performing 30 procedures. Data provenance: Simulator.
• Performance Characterization Animal In-Vivo Study: Part 1: 1 animal, 3 devices. Part 2: 1 animal, 5 devices. Data provenance: Porcine model (in-vivo).

Data provenance details (e.g., country of origin, retrospective/prospective) are not directly applicable as these are laboratory, simulator, or animal studies of a physical device, not patient data for an AI model.

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

For a physical medical device, "ground truth" often relates to objective measurements (e.g., integrity, dimensions) or expert assessment of functionality and usability.

• Design and Performance Validation Test: 2 trained surgeons. Qualifications not explicitly detailed beyond "trained surgeons."
• Usability Studies (Initial, Supplementary, Training Validation, Follow-up): Physicians of "varying levels of experience" were involved. The exact number of "experts" (or the most senior/experienced) who formally established performance metrics or approved the "ground truth" (i.e., whether a procedure was successful or a leak occurred) is not specified beyond their participation as test users. The methods (e.g., dye leak test) were objective.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjectively labeling data in AI ground truth establishment. For this physical device, the "adjudication" is inherent in the test protocols and measurements.

• Dye leak tests: This is an objective visual assessment.
• Dimensional, pressure, strength tests: These rely on objective measurement against prespecified criteria, not human consensus on subjective labels.
• Usability Studies: While surgeons performed the procedures, the outcomes like "observed leakage of dye" or "device leak" are objective observations rather than subjective interpretations requiring adjudication. "Minor device issues noted" would have been observed directly by the testers or study coordinators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating human reader performance (e.g., radiologists interpreting images) with and without AI assistance on complex medical cases. This device is a physical surgical tool, not an AI software tool for interpretation.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical product, not an algorithm. Its performance is always in the context of human use (e.g., surgeons performing procedures with it). The "non-clinical performance testing (bench)" and "animal studies" could be considered "standalone" in that they test the device's inherent properties and function, but not in the AI sense of algorithm-only performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through a combination of:

• Objective Measurement against Engineering Specifications: For tests like dimensional verification, burst pressure, puncturing force, bond strength, pressure relief valve performance, corrosion resistance.
• Controlled Biological/Physical Outcomes: For bacterial immersion (absence of growth) and viral penetration (meeting criteria).
• Expert Observational Assessment of Functionality: In simulated and in-vivo environments, such as dye leak tests after morcellation, maintenance of pneumoperitoneum, adequate space/visualization, and observation of proper deployment and removal without spillage. Usability studies assessed successful completion of tasks and adherence to IFU.

There is no "pathology" or "outcomes data" in the sense of clinical patient outcomes or histopathology for establishing ground truth for individual performance evaluations outlined.

8. The Sample Size for the Training Set

This question is not applicable for a physical device. There is no "training set" in the context of machine learning. The studies were validation tests.

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

This question is not applicable, as there is no training set for an AI model.

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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

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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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner 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 ASC PneumoLiner is an inflated morcellation containment system that allows for containment of gynecological tissue, cells and fluids during power morcellation and removal. It is a sterile single use device and requires the surgeon to successfully complete a validated training program before use. The ASC PneumoLiner is for clinical use in a hospital or surgical center operating room. The device consists of the following components: the Retractor Introducer, Boot Assembly, the PneumoLiner Introducer and the PneumoLiner. The first three components (Retractor, Retractor Introducer and Boot Assembly) are used to retract an incision in the abdominal wall and to allow for the introduction of laparoscopic instruments and the PneumoLiner Bag while under pneumoperitoneum and with vision from a laparoscope. The PneumoLiner Bag is introduced via the PneumoLiner introducer and the large valve on the Boot Assembly. The PneumoLiner is intended for use in gynecological power morcellation. It is intended to form a complete containment barrier from the spillage of liquids, cells and tissue from the time the tissue or organ is excised and encapsulated in the PneumoLiner bag, throughout the morcellation procedure and withdrawal of the containment bag with accompanying liquids and debris.

Based on the provided text, the device in question (PneumoLiner) is a medical device for contained morcellation, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies proving the device meets them, especially those pertaining to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size and ground truth establishment), is largely not applicable to this document.

The document describes a 510(k) submission for a revision to the labeling (indications for use and contraindications) of an existing device, and some non-clinical performance testing related to packaging and shelf-life. There are no mentions of AI/ML or a "study that proves the device meets the acceptance criteria" in terms of an AI/ML algorithm's clinical performance.

However, I can extract the relevant information regarding the changes made and the supporting information for those specific changes, which are primarily based on clinical literature reviews rather than a new clinical study of the device itself.

Since the request is about acceptance criteria and a study proving the device meets them, and this document describes a labeling change for a physical medical device, I will reframe the answer based on the information available:

Acceptance Criteria and Study for PneumoLiner (K192898 Labeling Revision)

The provided document (K192898 510(k) clearance letter) describes a submission primarily for a revision to the Indications for Use and contraindications of an existing medical device, the PneumoLiner. It also includes updated non-clinical performance data for shelf-life and packaging. It does not describe a clinical study of the device's efficacy or safety as an AI/ML system.

Therefore, many of the requested points related to AI/ML device performance are not applicable. I will address the relevant points based on the information provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k), the "acceptance criteria" appear to be related to the justification of the labeling changes and the non-clinical performance of packaging and shelf-life. The "performance" is demonstrated through literature review for the labeling changes and specific testing for packaging/shelf-life.

• JMIG Special Article, "Morcellation during Uterine Tissue Extraction: An Update by the Tissue Extraction Task Force Members" (2018).
• FDA Updated Assessment of the Use of Laparoscopic Power Morcellators to Treat Uterine Fibroids (December 2017).
• Seidhoff et al. (2017) meta-analysis.
  These sources stratify the risk of occult leiomyosarcoma (LMS) by age. |
  | Non-Clinical Performance (Shelf-Life & Packaging) | Sterilization validity. | Sterilization validated to ISO 11137-1:2006 and ISO 11137-2:2013. |
  | | Shelf-life validity (updated from 1 year to 3 years). | Tested on samples accelerated aged which underwent simulated shipping, including:
• Sterile Barrier Integrity testing
• Visual inspection per ASTM F1996:2009 (2013)
• Bubble leak testing per ASTM F2096:2011
• Seal strength per ASTM F88:2009.
• Device functionality (leak testing, bond/material strength testing). |

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

This is not applicable for a clinical performance test of an AI/ML algorithm. The "test set" for the labeling changes was the existing body of clinical literature. The provenance is explicitly cited as published academic journals and FDA assessments.

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

This is not applicable as an AI/ML algorithm was not being evaluated. The "ground truth" for the labeling changes was derived from peer-reviewed clinical literature and FDA assessments, which represent the consensus or findings of multiple medical experts and researchers in the field. The specific number of individual experts directly involved in "establishing ground truth" for this submission is not quantified in the document, as it relied on previously established and published data.

4. Adjudication Method for the Test Set

This is not applicable as an AI/ML algorithm was not being evaluated. The "adjudication" for the literature review was implicitly handled through the peer-review process of the cited publications and the FDA's own assessment methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is not for an AI-powered device.

7. The Type of Ground Truth Used

For the labeling changes, the "ground truth" was derived from published clinical literature, meta-analyses, and FDA assessments regarding the risk stratification of occult leiomyosarcoma (LMS) by age in women with presumed fibroids. This effectively represents:

• Expert Consensus (via peer-reviewed publications): The conclusions drawn in the cited articles reflect the collaborative findings and consensus (or significant findings) of experts in gynecology and oncology.
• Outcomes Data (clinical studies summarized in literature): The literature reviewed is based on real-world clinical outcomes and patient data that informed the risk stratification.

8. The Sample Size for the Training Set

This is not applicable as there was no AI/ML algorithm to train.

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

This is not applicable as there was no AI/ML algorithm to train.

In summary, the provided document describes a regulatory submission for a physical medical device (PneumoLiner) that involves labeling revisions and non-clinical performance testing for shelf-life and packaging. It is crucial to note that this is not an AI/ML-powered device and therefore, most of the questions related to AI/ML study methodologies are not relevant to this specific 510(k) clearance letter. The justification for labeling changes was based on existing clinical literature and expert-driven assessments.

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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.

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.

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