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The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.

The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.

The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.

The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.

The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.

The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.

The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.

The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Periloneal Catheter and the Pleurx Drainage Kits.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pleurx Peritoneal Catheter System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria with quantitative thresholds alongside reported device performance results in the way commonly seen for AI/ML devices or diagnostic tools. Instead, it lists the types of non-clinical tests performed and states that the device "meets or exceeds all performance requirements."

However, we can infer the "acceptance criteria" were implied by the referenced standards, and the "reported device performance" is a general statement of compliance.

2. Sample Size and Data Provenance

The document explicitly states: "N/A - No clinical tests were conducted for this submission".
Therefore, there is no information on:

• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Sample size for the training set.

3. Number of Experts and Qualifications

Since no clinical studies were performed, there is no mention of experts used to establish ground truth. The device's performance was evaluated through non-clinical, bench-level testing against established standards.

4. Adjudication Method

Not applicable, as no clinical studies with expert review were conducted.

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

Not applicable. No clinical studies were performed, and this device is a physical medical device (catheter system), not an AI/ML diagnostic tool typically assessed with MRMC studies.

6. Standalone Performance

The device's performance was evaluated in a standalone manner through "bench-level testing" and compliance with referenced standards. The statement "The results of the non-clinical tests show that the CareFusion Pleurx Peritoneal Catheter System meets or exceed all performance requirements" indicates standalone assessment against predefined engineering and material standards. This is not a "standalone algorithm performance" in the context of AI, but rather standalone physical device performance.

7. Type of Ground Truth

The "ground truth" for this device's evaluation was based on:

• Engineering and Material Standards: The various ISO, EN, ANSI/AAMI, and ASTM standards listed (e.g., ISO 10993 for biocompatibility, EN 1617 for drainage catheters, ASTM F1980 for aging).
• Predicate Device Characteristics: The existing predicate devices (e.g., CareFusion Pleurx Catheter Systems: K113854) set the benchmark for technological characteristics.

8. Sample Size for the Training Set

No information is provided, as no clinical studies or machine learning algorithms were involved that would require a "training set."

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

Not applicable, as no training set was used for this type of device submission.

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