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The Asept Pleural Drainage System is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions; including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.

The Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The catheter is implanted in the patient's pleural cavity enabling the patient to perform intermittent pleural effusion drainage at home or hospital. The primary components of the system are the Asept indwelling Pleural Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the pleural space until the valve is breached. The valve can be breached by the Asept Pleural Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Pleural Drainage System provides patients with a convenient way to relieve pleural effusion symptoms at home.

The provided text describes the "Asept Pleural Drainage System" and its safety and effectiveness summary for a 510(k) submission. However, it explicitly states that clinical studies were not deemed necessary and that in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.

Therefore, based on the provided text, a conventional study demonstrating the device meets stated acceptance criteria through human-in-the-loop, multi-reader, or standalone AI performance, with ground truth established by experts, does not exist. The approval was based on in vitro testing and substantial equivalence to a predicate device, not on a clinical trial with acceptance criteria for device performance.

Here's a breakdown of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values from BS EN 1618-1997 are not provided in the document, nor are specific quantitative performance results for the Asept Pleural Drainage System for these parameters. The document only states that "in vitro testing was performed... to assure reliable design and performance in accordance with BS EN 1618-1997."

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not deemed necessary since in vitro testing was sufficient..."
• Data Provenance: Not applicable. The testing was in vitro (laboratory-based) with device components, not involving human data.

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

• Not applicable. Ground truth for clinical outcomes was not established as there were no clinical studies. The "ground truth" for the in vitro tests would be the accepted standards defined in the BS EN 1618-1997 specification, which are objective engineering/material performance metrics.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study was not performed. Clinical studies were not deemed necessary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No. This device is a medical catheter system, not an algorithm or AI. Standalone performance as typically described for AI/algorithm assessment is not relevant here.

7. The Type of Ground Truth Used

• The ground truth used was objective engineering and material performance standards as defined by BS EN 1618-1997. This standard likely specifies acceptable ranges or thresholds for parameters like leakage, flow rate, tensile strength, and corrosion.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" in the context of an AI or statistical model. The device development process would involve iterative design and testing, but not a formally defined "training set" as in machine learning.

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

• Not applicable. As there was no training set in the context of AI, there was no ground truth established for it. The "ground truth" for the in vitro tests was the objective performance criteria specified in the relevant engineering standard.

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