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The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.

The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.

The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.

The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.

The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.

The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.

The Unimax Trocar System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes used for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage). The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, although it can be inferred that the testing was conducted by or for Unimax Medical Systems Inc., a company located in Taiwan. These were non-clinical bench tests performed on the device itself.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable. The Unimax Trocar System is a physical medical device, and the "ground truth" for its performance is established through objective engineering and safety tests rather than expert interpretation of medical images or clinical outcomes that would require expert consensus.

4. Adjudication Method for Test Set

This information is not applicable for a physical device undergoing performance and safety bench testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image analysis) to resolve discrepancies among multiple expert readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices or AI-assisted systems where human reader performance is being evaluated with and without AI assistance. The Unimax Trocar System is a surgical instrument.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The document explicitly states: "A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System." And "The performance testing conducted on subject device and predicate device are listed below: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage." The conclusion states, "After analyzing bench tests, safety testing data, it can be concluded that: Unimax Trocar System is as safe and effective as the predicate device."

7. Type of Ground Truth Used

The ground truth for the performance of the Unimax Trocar System was established through objective measurements and observation during non-clinical bench testing for physical characteristics (e.g., fit, stability, leakage) and through adherence to recognized international standards for biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).

8. Sample Size for Training Set

This information is not applicable. The Unimax Trocar System is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as there is no training set for this device.

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