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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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The Enpath ViaSeal Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The Enpath ViaSeal Valved Peelable Introducer is a small diameter tubular shaped device with integrated proximal handles. The ViaSeal Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system while providing hemostatic sealing to venous pressures. The ViaSeal Valved Peelable Introducer has a "peel-away" feature common to the predicate device. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.

The ViaSeal Valved Peelable Introducer is packaged in a sterile 5-pack convenience kit containing a ViaSeal Valved Peelable Introducer, a thin-wall needle, a disposable syringe, and a flexible guidewire. The kit is packaged in a PETG tray with a Tyvek lid, and a sealed Tyvek/LDPE pouch.

Introducer sizes of the sheath and dilator range from 7 French to 10.5 French. The materials and construction are the same for all French sizes. Enpath ViaSeal Valved Peelable Introducer kits will be packaged and ETO sterilized for one time use and sealed in a Tyvek/LDPE pouch.

The provided text is a 510(k) summary for the Enpath Medical ViaSeal Valved Peelable Introducer. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria in the manner typically seen for novel therapeutic devices or diagnostic AI systems.

Therefore, many of the specific questions about acceptance criteria, detailed study design, and AI model performance metrics cannot be directly answered from this document.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific acceptance criteria with quantifiable metrics such as sensitivity, specificity, accuracy, or a detailed breakdown of device performance against these. Instead, it makes a general statement about performance.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable/Not mentioned. The study was primarily non-clinical "performance testing."
• Data provenance: Not applicable/Not mentioned for clinical data. The performance testing would have been conducted internally by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was not a study requiring expert-established ground truth for diagnostic or interpretative tasks. It was performance testing of a medical device.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of expert interpretations.

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

Not applicable. This is a non-AI medical device (a catheter introducer). No MRMC study was conducted, and no AI component is involved.

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

Not applicable. This is a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic performance. For a medical device like this, "ground truth" would relate to engineering specifications, material properties, and functional performance benchmarks (e.g., ability to peel, maintain hemostasis, dimensions). These would be established through engineering and quality control standards.

8. The sample size for the training set

Not applicable. This is a non-AI medical device; no training set for an algorithm was used.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm was used.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" refers to a series of non-clinical performance tests conducted by Enpath Medical Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices.

• Study Title: "Summary of Studies" (as per the 510(k) document)
• Study Type: Non-clinical (in vitro/bench testing)
• Objective: To verify that the device functions in a safe and effective manner and performs per specification requirements, equivalent to predicate devices, without creating additional risk.
• Tests Performed:
  • Device specifications verification
  • Dimensional testing
  • Functional testing
  • Hemostasis testing to venous pressures
• Results: "Test results verify that the device performs per specification requirements and is equivalent to the predicate device without creating additional risk to the patient or user."
• Key Finding for Approval: The device was deemed "substantially equivalent" to the Enpath Medical FlowGuard Valved Peelable Introducer (K040150) and the Thomas Medical Products Inc. SafeSheath MSP Introducer Kit (K003731) based on these non-clinical tests.
• Clinical Evaluations: Explicitly stated: "No clinical evaluations for this submission have been conducted."

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The MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.

The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.

Here's a breakdown of the acceptance criteria and study information for the MedAmicus Valved Peelable Introducer based on the provided text:

Acceptance Criteria and Device Performance

Study Information

2. Sample size used for the test set and the data provenance:

• Test set sample sizes:
  • Valve Pressure Flowrate: 30 units
  • Valve Vacuum Flowrate: 29 units
  • Dilator Insertion Force: 29 units
  • Dilator Removal Force: 29 units
  • Catheter Insertion Force: 29 units
  • Valve Peeling Force: 29 units
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies internal testing by MedAmicus.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The study appears to be engineering/performance testing against specifications, rather than a clinical study requiring expert ground truth for interpretation of observational data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. The tests are focused on quantifiable physical properties and performance against predefined engineering specifications, not on subjective interpretations requiring adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical introducer, not an AI diagnostic tool.

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

• Not applicable. This device is a physical medical device, not an algorithm. The testing described is "standalone" in the sense that it evaluates the device's physical performance independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth consists of predefined engineering specifications and performance benchmarks (e.g., maximum force, minimum reduction percentage). These are derived from design requirements and potentially industry standards, not from clinical expert consensus, pathology, or outcomes data in the typical sense.

8. The sample size for the training set:

• Not applicable. This device is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. As there is no AI model or training set, this question is not relevant.

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