Search Results

The Auto Suture* Soft Thoracoport* obturator and sleeve is indicated for use in establishing a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required.

The Auto Suture* Soft Thoracoport** obturator and sleeve consists of a sterile, single-use, blunt-tipped obturator and a flexible threaded sleeve. The threaded sleeve has a shroud at its proximal end to protect against foreign materials entering the cavity and for instrument stabilization. The Auto Suture* Soft Thoracoport** obturator and sleeve is available in 5mm, 12mm and 15mm sizes.

The provided text describes the "Auto Suture* Soft Thoracoport** Obturator and Sleeve" device and its 510(k) summary, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/ML performance evaluation.

The document states:

• "Pre-clinical laboratory evaluations were performed to ensure that the device could be used as designed."
• "The studies demonstrated substantial equivalence to the predicate device in creating a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required."

This indicates that the evaluations were done to show substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. This is a different type of evaluation than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) for an AI/ML model and then conducting a study to demonstrate those criteria were met.

Therefore, I cannot fill out the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory approval based on pre-clinical evaluations and substantial equivalence to existing devices, not on the performance metrics typically associated with AI/ML systems.

Here's why I cannot provide the requested information from the given text:

1. Nature of the Device: The device is a surgical instrument (obturator and sleeve), not an AI/ML diagnostic or predictive system. Therefore, the concept of "acceptance criteria" for a fixed performance metric (like accuracy for an AI system) doesn't directly apply in the same way. The "performance data" section refers to pre-clinical evaluations ensuring it can be used as designed and is substantially equivalent to predicate devices.
2. Lack of Specific Performance Metrics: The text does not list any quantitative performance metrics (e.g., sensitivity, specificity, AUC, F1-score) that would constitute "acceptance criteria" for an AI model.
3. No AI/ML Study Details: The document does not describe any study involving AI, machine learning, human readers, or ground truth establishment in the context of an algorithm's performance.

If this were an AI/ML device, the detailed information requested would typically be found in a dedicated "Clinical Study Report" or "Performance Study" section of the 510(k) submission, clearly defining the study design, endpoints, and results. The provided text is a summary of safety and effectiveness, focused on the regulatory pathway of substantial equivalence.

Ask a specific question about this device