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The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.

This document is a 510(k) summary for the Laport® Trocars. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data in a quantitative, statistical manner typically seen for complex AI/ML medical devices. Therefore, much of the requested information regarding statistical studies, expert adjudication, and sample sizes for training/test sets is not available in this document.

However, I can extract the information that is present and highlight the type of testing performed.

Type of Device: Surgical Trocar (not an AI/ML device)

Given that this is a 510(k) submission for a surgical trocar, physical and chemical performance tests are presented, not diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device testing (e.g., MRMC studies, ground truth establishment for AI, training set size) are not applicable or detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical trocar, acceptance criteria are generally qualitative or based on passing specific physical, chemical, and biological tests. The document describes the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices," implying successful completion of these tests. Specific numerical acceptance criteria or performance values are not provided in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not explicitly stated in the document for any of the performance tests. For animal testing, it mentions "micropigs" but not the number of animals used.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study is described as "Non-Clinical(Animal) test using micropigs," implying a prospective animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the non-clinical (animal) tests, it states "The operator (expert veterinarian) scored the experience." This indicates at least one expert, but the exact number and detailed qualifications (e.g., years of experience) are not provided beyond "expert veterinarian." This is not a "ground truth" establishment in the sense of clinical disease diagnosis, but rather an expert evaluation of device performance.

4. Adjudication method for the test set

• Not applicable/Not described. The expert veterinarian "scored the experience," suggesting a single evaluation per test, not a consensus or adjudication process involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. This type of study is relevant for diagnostic devices (especially AI/ML image analysis) where human reader performance is being evaluated or compared. It is not applicable for a surgical trocar.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this device. For the performance tests, the "truth" is determined by meeting engineering specifications, ISO standards, and the assessment by an expert veterinarian for handling characteristics in an animal model.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device that requires a training set.

Summary specific to the provided document:

The provided document describes a 510(k) submission for a surgical trocar (Laport®). The "acceptance criteria" discussed are primarily compliance with ISO standards for sterilization, biocompatibility, and various physical and mechanical performance tests (e.g., appearance, measurement, leakage, extraction). A non-clinical animal test was also conducted, where an "expert veterinarian" evaluated the device's insertion, fixation, extraction, intraperitoneal pressure management, and convenience for laparoscope use.

The document states that all tests demonstrated that the device is "substantially equivalent to the predicate devices." However, it does not provide quantitative performance metrics, specific numerical acceptance thresholds, or statistical analysis of the test results. The sample sizes for these tests are also not specified in this summary. This is typical for 510(k) summaries for such devices, where the focus is on demonstrating equivalence through a battery of standard tests rather than detailed statistical clinical trials, especially if it's not a novel technology or an AI/ML device.

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The MGB LAPORT sterile Trocars for Endoscopic surgery are intended to establish a path of entry for endoscopic abdominal, for use during general, instruments gynaecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "LAPORT / Trocar for laparoscopic procedures." It indicates that the device has been found substantially equivalent to predicate devices.

However, this document does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the 510(k) submission itself, or in supplementary documents describing the performance testing.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document primarily focuses on:

• Device identification: LAPORT / Trocar for laparoscopic procedures, K092584.
• Regulatory classification: Class II, Product Code GCJ, Regulation Number 21 CFR 876.1500 (Endoscope and accessories).
• Substantial equivalence determination: The FDA concluded the device is substantially equivalent to legally marketed predicate devices.
• Indications For Use: To establish a path of entry for endoscopic abdominal, general, gynecological, and thoracic minimally invasive procedures.
• General regulatory requirements.

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