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The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions

TroClose1200™ bladeless trocar

This document is a 510(k) clearance letter from the FDA for a medical device called TroClose™ / TroClose1200™. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA believes it is as safe and effective as existing devices on the market, but it does not detail performance metrics or studies in the way you've requested.

Therefore, I cannot provide the information you asked for based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the study report itself.

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The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions.

The TroClose1200™ is a Trocar system comprised of an Obturator and a Cannula including preloaded sutures. It includes a bladeless Obturator, designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two absorbable PGLA sutures, each attached to an absorbable PLGA anchor. The deployment of the anchors and sutures ("closure device) is achieved by utilizing two pushers within the Obturator as a deployment mechanism.

The TroClose1200™, as one unit, consists of the following components:

• . An Obturator, which is the part of a trocar that allows the insertion of the trocar (after routine scalpel-made incision). An Obturator is for single patient use. For this purpose, the Company's Obturator is bladeless, similar to the predicate Obturator. In addition, the Company's Obturator has a set of 2 pushers that deploy (the closure device's deployment mechanism) the anchors with sutures attached from the Cannula for later closure.
• A Cannula, which is the part of a trocar that establishes the working channel through which the surgeon introduces surgical tools while keeping the CO2 in the abdominal lumen. The Cannula is for single use and is similar to the predicate trocar Cannula. In addition, the Company's Cannula has 2 absorbable anchors attached to absorbable threads, at 180° to each other, as the closure device, which is similar to the predicate closure device. The thread (suture) is made of absorbable PGLA and the anchors are made of absorbable PLGA and is designed to close the access port by suturing the abdominal wall's fascia.

GORDIAN 's TroClose1200™ is manufactured from routinely used medical device biocompatible materials.

Like its' predicates, this disposable device is provided sterile (by EtO) and intended for single patient (Obturator) and single use (Cannula) only.

The document describes the TroClose1200™ Trocar System, a medical device intended for use in gynecologic, general, and urologic endoscopic/laparoscopic procedures to create and maintain a port of entry and facilitate the delivery of absorbable sutures and anchors. The document focuses on demonstrating the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance metrics for classification as a diagnostic AI/ML device.

Therefore, the specific information requested about acceptance criteria, performance metrics, sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and comparative effectiveness studies (MRMC) for an AI/ML diagnostic device is largely not applicable to this document. The provided text describes a physical surgical device and its safety/performance testing for FDA clearance as "substantially equivalent" to existing predicate devices under 510(k).

Here's an analysis based on the available information, noting the missing elements due to the nature of the device:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of a diagnostic performance target (e.g., sensitivity, specificity). Instead, it lists performance tests conducted to demonstrate the device meets its intended use and is comparable to predicate devices. The "reported device performance" is generally stated as "successfully achieving its intended use" or "comparable to the two functions provided by separate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not explicitly stated for each individual test. The document refers to "Performance data" and lists various tests, but doesn't quantify the number of devices or animals used for each.
• Data Provenance: The document mentions "GLP animal studies," implying professional, controlled studies. It does not specify the country of origin for the studies, but the company is located in Israel. The studies are prospective in nature as they involve testing the device.

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

This is not applicable as the document describes a physical surgical device, not an AI/ML diagnostic system requiring expert-established ground truth on a dataset. The tests are primarily engineering, mechanical, material, and biological evaluations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable for the reasons stated above. Adjudication methods are typically for subjective assessments of diagnostic output, which is not the case here.

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:

This is not applicable as the document describes a physical surgical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical surgical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

For the animal studies, the "ground truth" would be physiological and histological observations of the tissue response, healing, and device functionality in vivo, as well as comparison to the performance of predicate devices and hand suturing. For the bench tests, the "ground truth" is established by adherence to recognized standards (e.g., USP, ASTM, ISO) and comparison to the specifications of predicate devices.

8. The sample size for the training set:

This is not applicable as the document describes a physical surgical device, not an AI/ML system that requires a training set.

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

This is not applicable for the reasons stated above.

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