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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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