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The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for:

• Intermittent drainage of symptomatic, recurrent, malignant ascites that does not ● respond to medical management of the underlying disease
• Palliation of symptoms related to recurrent malignant ascites ●
• Peritoneal placement only ●

The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.

The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is a 510(k) summary for the Pleurx Peritoneal Catheter Kit and Drainage Kits, which is a medical device, but it is not an AI/ML device. The document focuses on the substantial equivalence of this device to previously marketed devices, rather than on the performance criteria or studies typical for AI/ML products.

Therefore, I cannot extract information such as:

1. A table of acceptance criteria and reported device performance (for an AI/ML model)
2. Sample sizes for test sets, data provenance, and ground truth establishment methods for an AI/ML model
3. Information about experts, adjudication methods, or MRMC studies for AI/ML performance evaluation
4. Standalone algorithm performance or training set details for an AI/ML model.

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The Pleurx Pleural Catheter 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 Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.

The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.

The provided text describes a 510(k) premarket notification for a medical device, specifically a modification to the Denver Pleural Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a formal study with quantitative performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. This type of information is typically found in design verification and validation reports or clinical study summaries, which are often summarized in a 510(k) but not always presented with full detail on performance metrics.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

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

The document does not explicitly mention a "test set" in the context of performance evaluation for the modified device. The evaluation performed was primarily for substantial equivalence based on material properties.

• No specific sample size for a test set is provided.
• Data provenance is not explicitly stated, but the evaluation involves "reviewing biocompatibility data" and "testing." These likely refer to pre-existing data for the alternate fabric and new testing conducted by the manufacturer, respectively. No country of origin for data is mentioned. The study is retrospective for biocompatibility data review and likely prospective for the physical testing of the new material.

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

Not applicable. The evaluation focused on material equivalence and bond strength, not on clinical performance requiring expert ground truth establishment for a diagnostic or predictive algorithm.

4. Adjudication method for the test set

Not applicable. The evaluation did not involve a test set requiring adjudication in the context of clinical performance. The review and testing were internal to the manufacturer's quality control/engineering processes.

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 device is a medical catheter, not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study is not relevant to its evaluation.

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.

7. The type of ground truth used

For the material and bond strength evaluation:

• Biocompatibility: Established standards and existing data for the alternate fabric material (e.g., ISO 10993).
• Physical and Chemical Specifications: Manufacturer's internal specifications and comparative analysis with the predicate material specifications.
• Bond Strength: Manufacturer's internal specifications for acceptable bond strength.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device.

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The Denver Pleural Effusion Shunt is indicated for use in patients with chylothorax, intractable aseptic pleural effusion. The Denver Pleural Effusion Shunt with External Pump Chamber is indicated for adult, pediatric, and neonatal patients with: chylothorax, intractable pleural effusion.

The Denver Pleural Effusion Shunt with External Pump Chamber has three major components: 1. A 15.5 Fr silicone catheter, which is implanted in the pleural space and collects the accumulated pleural effusion fluid. In the shunt with the externalized pump chamber, the catheter is tunneled subcutaneously and incorporates a polyester cuff. 2. A valved pump chamber, which is either implanted or remains external to the body. The patient compresses the pump chamber to transfer fluid from the pleural space to the peritoneum. 3. A second 15.5 Fr. silicone catheter, similar to the first, which terminates in the abdominal cavity. This catheter also bears a polyester cuff in the shunt with the externalized pump chamber. Except for the polyester cuff, all components of the shunt are made of silicone rubber.

This 510(k) summary describes a modification to an existing device, the Denver Pleural Effusion Shunt, specifically a change in the supplier of the silicone tubing used to fabricate the catheters. The focus of the submission and testing is to demonstrate that the modified device is substantially equivalent to the original device, not to prove the efficacy or safety of the device against specific clinical acceptance criteria in a new study. Therefore, traditional "acceptance criteria" for clinical performance are not explicitly stated or met in the same way a de novo device would.

Instead, the acceptance criteria for this submission revolve around confirming that the new silicone tubing performs equivalently to the old tubing and does not negatively impact the overall device performance or safety.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on the specific sample sizes for the bonding or biocompatibility tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. Given the nature of a material change submission, these tests would typically be laboratory-based (in-vitro) rather than clinical studies on human subjects.

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

This section is not applicable to this 510(k) submission. The "ground truth" for a material change submission is primarily established through engineering tests (material characterization, bonding strength, etc.) and biocompatibility tests, which are evaluated against established standards and internal specifications, not by expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments. The tests described here are laboratory-based.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant to a material change submission for a mechanical device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This section is not applicable. This device is a mechanical shunt, not an AI algorithm. Therefore, there is no "standalone performance" in the context of AI. The performance of the device (e.g., fluid transfer, patency) is inherent to its mechanical design and material properties.

7. Type of Ground Truth Used:

The "ground truth" for this submission primarily relies on:

• Material Specifications: Comparing the properties of the new silicone tubing to the established specifications of the original tubing.
• Performance Standards: Demonstrating the new tubing's ability to bond properly and the biocompatibility of the material using recognized test methods (e.g., ISO standards for biocompatibility).
• Substantial Equivalence Principles: The core ground truth for the 510(k) is the comparison to the predicate device to determine substantial equivalence.

8. Sample Size for the Training Set:

This section is not applicable. "Training set" refers to data used to train machine learning algorithms. This submission is for a mechanical medical device, not an AI/ML product.

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

This section is not applicable for the same reasons as point 8.

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Peritoneo-venous shunting is indicated for patients with:

• chronic liver disease whose ascites has not responded to surgical correction of their underlying disease and to medical management.
• persistent ascites who are not considered candidates for portal-venous shunting.
• persistent ascites that is non-responsive to standard medical management.
• peritoneal intra-abdominal neoplasms with massive ascites to help relieve abdominal distension and intra-abdominal pressure.
  Peritoneo-venous shunting should also be considered for patients with hepatorenal syndrome and idiopathic ascites.

The Denver Ascites shunt is made of a fenestrated peritoneal catheter, which collects the ascites fluid; a one-way valve, which allows flow from the peritoneum to the venous system but no reverse flow; and a venous catheter, which discharges the ascites fluid into the central venous system.
The fluid transfer happens automatically when the patient lies down, because of the pressure differential between the peritoneal cavity and the central venous system. The spontaneous rate of transfer can be supplemented by manual pumping of the chamber. Pumping may also help limit buildup of fibrinous debris in the chamber.
All components of the shunt are made of silicone rubber.

1. Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample size for the test set regarding the various physical and biocompatibility tests. It broadly mentions "comparing" and "testing to ensure/verify" without enumerating samples.
• The data provenance is not specified (e.g., country of origin).
• The study is retrospective in nature, focusing on the characterization and comparison of the new tubing material against established specifications of the previously used tubing and the legally marketed device.

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

• This information is not provided. The ground truth for the test set for device performance heavily relies on established engineering specifications, material science standards, and biocompatibility guidelines rather than expert consensus on interpretative outputs (like in imaging devices).

4. Adjudication method for the test set:

• This information is not applicable and not provided. The tests described are objective measurements against pre-defined specifications, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI. This submission is for a material change in a medical device (Denver Ascites Shunt).

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

• This question is not applicable to this medical device submission. The device is a physical shunt; there is no "algorithm" in the sense of a software-based diagnostic or assistive tool. The "standalone" performance refers to the device's physical and biological integrity as a component of the shunt system.

7. The type of ground truth used:

• The ground truth used for this study is based on established engineering specifications, material property standards, and biocompatibility standards. These are objective, quantitative criteria for material composition, physical dimensions, mechanical properties (bond strength, friction fit), and biological safety. The "legally marketed shunt" served as the primary reference for substantial equivalence.

8. The sample size for the training set:

• This information is not applicable and not provided. This modification involves a change in a physical component (tubing) of a medical device, not a machine learning algorithm that requires a training set.

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

• This information is not applicable. As stated above, there is no "training set" in the context of an AI/ML algorithm for this device modification.

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The Denver® Pleurx® Pleural Catheter Kit and the Denver® Pleurx® Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other pleural effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the relief of symptoms associated with pleural effusion, and 2) to provide a means for the instillation of physician-prescribed medications into the pleural space, and 3) to provide a means for pleurodesis (resolution of the pleural effusion).

The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.

This 510(k) summary describes a modification to an already legally marketed device, the Denver Pleural Catheter. Therefore, the "study" described is a series of tests to demonstrate that the modified device is substantially equivalent to the original device, rather than a clinical study proving efficacy or safety from scratch.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) states that the catheters made of the modified materials have been found "substantially equivalent" to the legally marketed catheter, implying that the performance of the new components aligns with the established performance and safety profile of the original device.

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

• Sample Size: The document does not explicitly state the numerical sample sizes used for each test (e.g., how many tubing samples were tested for bond strength or biocompatibility). It describes the types of tests performed.
• Data Provenance: Not explicitly stated, but given the context of a 510(k) submission by a medical device manufacturer, these tests would typically be performed in-house or by accredited contract labs specializing in medical device testing. The data would be prospective for the modified components, meaning the tests were conducted specifically to evaluate these new materials. There is no information on country of origin for the data, but it would be expected to adhere to US regulatory standards for medical devices.

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

• Not Applicable in this context. This 510(k) is about material changes to a device, not about evaluating a diagnostic algorithm or a clinical outcome. Therefore, there is no "ground truth" to be established by experts in the sense of medical diagnosis or clinical interpretation. The "ground truth" here is adherence to engineering specifications and regulatory standards for biocompatibility. These standards are established by regulatory bodies and industry norms, and adherence is verified through laboratory testing.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies between readers. For material testing, acceptance is determined by meeting predetermined numerical specifications (e.g., bond strength within a certain range, biocompatibility test results showing no adverse reaction).

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. This document is a 510(k) for a physical medical device (a catheter) and its material changes. It does not involve AI or human readers, and therefore no MRMC study was conducted.

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

• No. This is a physical medical device, not an algorithm, so "standalone performance" in that sense is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for the modified components is based on pre-defined engineering specifications, physical property standards, established biocompatibility standards (e.g., ISO 10993 for medical devices), and FDA-cleared predicate material performance. The goal was to demonstrate that the new materials meet these established benchmarks and perform equivalently to the materials in the already cleared device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI model, so there is no training set. The "training" for such a device would be the extensive research and development that led to the original design and the selection of materials conforming to standards.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" in the context of device development for the original catheter would have been an iterative process of design, testing, and validation against a combination of engineering requirements, clinical needs, safety standards, and ultimately, a successful FDA clearance based on substantial equivalence to a predicate device.

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