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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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