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The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.

The proposed device is an iteration of Applied Medical's GelPort Blunt Tip Trocar System. The predicate GelPort system provides a single access port and must therefore be used in combination with additional ports. Three ports is common, each requiring a dedicated incision. The proposed device, in essence, combines three of the single port predicates into one compact construct that requires but a single incision. A fourth port is included in the package as an option.
The proposed device is a sterile, single-use instrument intended to access abdominal, thoracic and pelvic cavities in preparation for endoscopic surgical procedures. It features a sleeve type wound retractor and a detachable cap. The wound retractor consists of a flexible polyurethane cylindrical sheath that has a semi-rigid polyurethane inner ring attached at each end. The detachable Gel-cap is constructed of a semi-rigid polycarbonate ring and a flexible gel-like material. The Gel-cap is fastened to the wound retractor with a locking attachment lever. The Gel-cap can accommodate up to four access ports that are inserted through the gel in a formation preferred by the user. The ports accommodate laparoscopic tools ranging from 4.8 to 13.2mm and have sealing features that allow insufflation of the surgical space.

The provided text describes the regulatory clearance of a medical device (GelPOINT Mini Advanced Access Platform) and outlines the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML-driven medical device, such as performance metrics (accuracy, sensitivity, specificity), details on test set data (sample size, provenance), expert ground truth establishment, or multi-reader studies.

The document focuses on non-clinical performance testing for a physical medical device (an endoscopic access platform), not a software or AI-based device. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and study.

Below, I will extract the information that is present in the document relevant to non-clinical performance testing and note where the requested information is not applicable or not provided.

Study Proving Device Meets Acceptance Criteria for GelPOINT Mini Advanced Access Platform

This document describes the non-clinical performance testing used to demonstrate substantial equivalence of the GelPOINT Mini Advanced Access Platform to its predicate device, the GelPort Blunt Tip Trocar System. The testing primarily focused on the physical and functional aspects of the access platform.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Predicate and proposed devices met all testing acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. Instead, it describes the types of functional tests performed.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for "side-by-side bench testing" of the proposed and predicate devices.
• Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. The testing was bench testing (laboratory-based, physical performance testing) rather than involving human subject data or retrospective/prospective patient data. The manufacturer is "Applied Medical Resources Corporation" based in California, USA, where the testing presumably took place.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This type of testing (functional performance of a physical surgical access device) does not involve medical image interpretation or clinical decision-making that would require expert-established ground truth. The ground truth refers to the physical functionality and safety parameters measured in the lab.

4. Adjudication Method for the Test Set

• Not Applicable: No adjudication of expert opinions was necessary as the study was non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This was not an MRMC study. MRMC studies are typically performed for imaging diagnostics or AI-assisted interpretation, where human reader performance is evaluated. This document describes the testing of a physical surgical access device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The device functionality was tested standalone in a bench setting.

7. The Type of Ground Truth Used

• Bench Test Measurements/Physical Properties: The "ground truth" for this study was based on objective measurements of physical and functional properties during bench testing (e.g., resistance to detachment, leak rates, particulation, resealing ability, drag force) and biological compatibility.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable: As above, no training set was involved.

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