Search Results

The Versaport™ Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Device Description

The Versaport™ V2 bladeless optical trocar with a low profile design and transparent fixation cannula is available in 5 mm standard (100mm), 5 mm short (70mm) and 5mm long (150mm) cannula lengths. The Versaport™ V2 bladeless optical 5mm trocar with transparent fixation cannula and obturator allows optical entry for visualization of tissue layers during insertion. The obturator housing contains a scope retention mechanism. The trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5 mm Versaport™ seal system accommodates 5mm instruments respectively. There is a luer lock with cap for insufflation and rapid desufflation.

AI/ML Overview

Here's an analysis of the provided text regarding the Versaport™ V2 Bladeless Optical Trocar System, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification to the FDA. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting full, detailed study reports with specific acceptance criteria and detailed quantitative results for each test. The document states that tests were performed and what types of tests were performed to establish substantial equivalence for various performance aspects, but it does not explicitly list quantitative acceptance criteria for each test nor specific numerical results demonstrating how the device met those criteria.

Therefore, for many of the requested points, the answer will be that the information is not provided in this summary.

Acceptance Criteria and Study Details for Versaport™ V2 Bladeless Optical Trocar System

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not explicitly state quantitative acceptance criteria for the enumerated performance tests. It states that "In-vitro and in-vivo tests were performed to verify that the performance of the Versaport™ V2 Bladeless Optical 5mm trocar is substantially equivalent to the predicate device, Endopath® Xcel trocar [K011257]". This implies that the acceptance criteria were likely based on matching or being within a permissible range of the predicate device's performance, but the specific numerical targets are not disclosed.

Therefore, the table below reflects the types of tests performed and the general conclusion drawn from the summary, rather than specific acceptance criteria and performance values.

Test Category	Specific Test Description	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Mechanical Performance (In-Vitro)	Leak Resistance	Likely: Equivalent to or better than predicate device (Endopath® Xcel trocar [K011257]) for preventing leakage during use.	Verified to perform as intended and is substantially equivalent to predicate device.
	Penetration and Fixation Forces	Likely: Within acceptable range for safe and effective tissue penetration and secure fixation, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
	Snap Feature Retention Force	Likely: Sufficient force to maintain obturator-cannula connection during use, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
	One-Handed Use	Likely: Demonstrates feasibility and ease of single-handed operation, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
	Scope Insertion and Retention Forces	Likely: Appropriate force for scope insertion and secure retention during use, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
Mechanical Performance (In-Vivo)	Penetration and Fixation Forces	Likely: Within acceptable range for safe and effective tissue penetration and secure fixation in biological systems, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
	Insertion and Removal Forces	Likely: Appropriate forces for smooth insertion and removal without excessive trauma, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
	Multiple Penetration Forces	Likely: Maintains performance consistency over multiple uses/insertions, comparable to predicate.	Verified to perform as intended and is substantially equivalent to predicate device.
Functional Performance (In-Vivo)	Visualization of Tissue Layers	Likely: Clear and adequate visualization of tissue layers during insertion, comparable to predicate's optical capabilities.	Verified to perform as intended and is substantially equivalent to predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample sizes used for any of the in-vitro or in-vivo tests.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, the studies would typically be prospective for performance validation, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. These types of studies for a surgical trocar would typically involve engineers and potentially medical professionals (e.g., surgeons) for aspects like "Visualization of Tissue Layers" or "In Vivo" tests, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of these engineering and in-vivo performance tests, typical adjudication methods (like 2+1 or 3+1 consensus commonly seen in imaging studies) are unlikely to be directly applicable. The "ground truth" would be established through direct measurement, observation, or expert assessment against predefined criteria.

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

No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic tools or imaging analysis where human readers interpret results. The Versaport™ V2 is a surgical trocar (medical device for creating a port of entry), not an AI diagnostic system.

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

No, this is not applicable. The Versaport™ V2 is a mechanical surgical device and does not involve algorithms or AI. It is inherently a human-in-the-loop device (used by a surgeon).

7. The Type of Ground Truth Used

Based on the types of tests mentioned ("In Vitro Leak Resistance," "In Vivo Penetration and Fixation Forces," "In Vivo Visualization of Tissue Layers"), the ground truth would be established through:

Direct Measurement: For forces, leak rates, resistance.
Observational Assessment by Qualified Personnel: For aspects like "visualization of tissue layers" (likely by surgeons or trained medical personnel in an in-vivo setting) and qualitative aspects of one-handed use or ease of insertion/removal.
Comparison to Predicate Device Performance: The overarching ground truth is framed as "substantial equivalence" to the Endopath® Xcel trocar [K011257].

8. The Sample Size for the Training Set

Not applicable / Not provided. This device is not an AI/machine learning product, so there is no "training set" in that context. If referring to a design validation or development phase, the sample sizes for such iterations are not disclosed.

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

Not applicable / Not provided. As mentioned above, there is no "training set" in the context of an AI device for this product. The ground truth for its performance validation (as discussed in point 7) was established through direct measurement, observation, and comparison to a predicate device.

Ask a Question

Ask a specific question about this device

Page 1 of 1