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The Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleural Catheter Kits are indicated for adults only.

The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The Pleur X Access Valve attaches only to the PleurX Valve Kit is intended to repair the Pleur X Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only.

The Pleur X LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.

The Pleurx Pleural Catheter System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.

The CareFusion Pleurx Pleural Catheter System, cleared under K160450, is a medical device for draining symptomatic, recurrent pleural effusion. The provided text indicates this 510(k) submission is for a change in material formulation and concentration, and minor design modifications to the devices previously cleared under K141965. No clinical studies were conducted for this submission. The device's acceptance criteria and performance are based on a series of non-clinical, in-vitro performance tests and biocompatibility studies.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data. The performance was evaluated through non-clinical laboratory testing against recognized standards. The provenance of the data is from these laboratory tests, which are typically conducted in a controlled environment, not on human subjects or patient data.

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

This information is not applicable as no clinical tests were conducted and thus no expert-established ground truth from a test set in a clinical context. The "ground truth" for non-clinical tests is established by adherence to the specified standards and the objective measurement of device performance against the requirements of those standards.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used requiring expert 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:

Not applicable. The Pleurx Pleural Catheter System is a physical medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way typically associated with MRMC studies.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the device's performance is based on the objective measurements and pass/fail criteria defined by the internationally recognized standards (e.g., ISO, AAMI, ASTM, EN) listed in the "Performance Test Summary" section. For example, biocompatibility is evaluated against the requirements of ISO 10993 standards, and physical performance against specific EN standards.

8. The sample size for the training set:

Not applicable, as no clinical or AI-based training set was used. The submission is about modifications to an existing device and relies on non-clinical testing.

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

Not applicable, as no training set was used.

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The Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, mcluding malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids

The Pleurx Pleural Catheter System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.

The provided text describes a 510(k) premarket notification for the Pleurx Pleural Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study where the device performance is measured against specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from this document. The submission relies on non-clinical (bench) testing to support its claims of substantial equivalence for a labeling update.

Here's what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance:

This 510(k) submission updates previously cleared device labeling to include the use of sclerosing agents (Talc and Bleomycin) with the Pleurx Pleural Catheter System. The acceptance criteria for this specific submission relate to the validation of this change through biocompatibility and bench testing. The "performance data" section lists standards and tests conducted, implying that the device "passed" or met the requirements of these standards. However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided for the device's clinical function in this document.

For example, for Biocompatibility, the acceptance criterion would be "meets ISO 10993-1, -3, -4, -5, -6, -10, -11 requirements" and the reported device performance is "passed" or "met." The specific metrics and thresholds for each test are not detailed in this summary.

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

• Test set sample size: Not specified. The document refers to "non-clinical tests," which likely involve a number of samples for each bench test conducted according to the standards.
• Data provenance: Non-clinical (bench) testing data. The country of origin is not specified, but the standards cited are international (ISO, EN, ASTM, AAMI).

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

Not applicable. Given this is a non-clinical (bench) testing submission, expert opinion for establishing a "ground truth" in the clinical sense is not relevant. The "ground truth" for these tests would be the established pass/fail criteria within the cited international standards by which the device was evaluated.

4. Adjudication method for the test set:

Not applicable. This type of adjudication is typically for clinical studies where subjective assessments might be involved. For bench testing, the results are typically objective measurements against a standard.

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 not an AI/software device and no MRMC study was conducted. The document explicitly states: "N/A – No clinical tests were conducted for this submission."

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the specific test method and acceptance criteria outlined in the cited international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for ethylene oxide sterilization).

8. The sample size for the training set:

Not applicable. This is not an AI/software device, so there is no training set in that context.

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

Not applicable, for the same reason as above.

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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 Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 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 pleural space.

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

The Pleurx Pleural Cather System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.

The provided document describes the 510(k) submission for the CareFusion Pleurx Pleural Catheter System. This submission focuses on expanding the indications for use and adding accessories to an existing legally marketed device. Therefore, the information provided primarily concerns non-clinical testing for substantial equivalence, rather than a clinical study evaluating the device's performance against specific acceptance criteria for efficacy or accuracy in the way an AI/ML device would be assessed.

Here's a breakdown of the requested information based on the provided text, with notes where the information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with various recognized standards for medical device safety and performance, and the "reported device performance" is the conclusion that the device meets or exceeds these standards, demonstrating substantial equivalence to predicate devices. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, or accuracy) reported that would be typical for an AI/ML device.

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

This information is N/A. The document states, "N/A - No clinical tests were conducted for this submission." The testing described is non-clinical (biocompatibility, performance characteristics like sterilization, packaging integrity, etc.) and refers to compliance with standards rather than a test set of patient data.

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

This information is N/A as no clinical test set requiring expert ground truth was conducted.

4. Adjudication Method for the Test Set

This information is N/A as no clinical test set requiring adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

This information is N/A. This is not an AI/ML device, and no MRMC study was conducted.

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

This information is N/A. This is not an AI/ML device.

7. The Type of Ground Truth Used

This information is N/A as no clinical ground truth was established for this submission. The "ground truth" for this submission is adherence to recognized non-clinical performance standards and substantial equivalence to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is N/A. This is not an AI/ML device, and therefore no training set was used.

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

This information is N/A. This is not an AI/ML device, and therefore no training set or its associated ground truth was established.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of national and international standards related to biocompatibility, sterilization, packaging, and general catheter performance. The submission concludes that these non-clinical tests collectively show the CareFusion Pleurx Pleural Catheter System meets or exceeds all performance requirements and is substantially equivalent to existing predicate devices. No clinical studies were conducted for this specific 510(k) submission, as it focused on expanding indications and adding accessories to an already legally marketed device by demonstrating equivalence to previously cleared devices and adherence to established non-clinical performance and safety standards.

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The Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 Dressing Kits are indicated for dressing of a catheter and exit site.

The Pleurx Pleural Catheter System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pleurx Pleural Catheter System:

The provided document is a 510(k) summary for the Pleurx Pleural Catheter System, primarily focusing on establishing substantial equivalence to predicate devices. As such, it details non-clinical tests rather than clinical studies with human participants. Therefore, many of the requested points related to clinical studies, ground truth establishment, expert adjudication, and human reader performance will not be applicable.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not describe a test set in the context of a clinical study or a dataset for an AI/algorithm. The tests listed are non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests on the device itself.
   • Data provenance: Not applicable in the context of clinical data. The tests are laboratory-based, not using patient data from specific countries.

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

   • Not applicable. No "ground truth" in the sense of clinical diagnoses or interpretations by experts was established for these non-clinical engineering and material tests. The "ground truth" for these tests would be the specifications and requirements defined by the referenced standards.

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

   • Not applicable. There was no adjudication process described for clinical interpretations or diagnoses.

4. 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 MRMC study was done. This device is a physical medical device (catheter system), not an AI/software device that assists human readers.

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

   • No standalone algorithm performance study was done. This is a physical medical device.

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

   • For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced ISO, EN, and ASTM standards (e.g., specific thresholds for chemical residuals, packaging integrity, material properties, sterilization efficacy). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

   • Not applicable. As there is no training set for an AI model, this question does not apply.

Summary of the Study:

The document describes a submission for a Pleurx Pleural Catheter System, which is a physical medical device. The "study" referenced in the acceptance criteria section consists of a series of non-clinical performance, biocompatibility, and sterilization validation tests. These tests were conducted against established international and national standards (ISO, EN, ANSI/AAMI, ASTM). The purpose of these tests was to demonstrate that the new device meets the necessary safety and performance requirements and is substantially equivalent to existing predicate devices. No clinical studies or studies involving human data, AI algorithms, or expert interpretations were conducted or reported for this 510(k) submission. The conclusion explicitly states: "N/A - No clinical tests were conducted for this submission."

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