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The Asept Pleural Drainage System 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 Asept Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The catheter is implanted in the patient's pleural cavity enabling the patient to perform intermittent pleural effusion drainage at home or hospital. The primary components of the system are the Asept indwelling Pleural Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the pleural space until the valve is breached. The valve can be breached by the Asept Pleural Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Pleural Drainage System provides patients with a convenient way to relieve pleural effusion symptoms at home.

The provided text describes the "Asept Pleural Drainage System" and its safety and effectiveness summary for a 510(k) submission. However, it explicitly states that clinical studies were not deemed necessary and that in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.

Therefore, based on the provided text, a conventional study demonstrating the device meets stated acceptance criteria through human-in-the-loop, multi-reader, or standalone AI performance, with ground truth established by experts, does not exist. The approval was based on in vitro testing and substantial equivalence to a predicate device, not on a clinical trial with acceptance criteria for device performance.

Here's a breakdown of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values from BS EN 1618-1997 are not provided in the document, nor are specific quantitative performance results for the Asept Pleural Drainage System for these parameters. The document only states that "in vitro testing was performed... to assure reliable design and performance in accordance with BS EN 1618-1997."

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not deemed necessary since in vitro testing was sufficient..."
• Data Provenance: Not applicable. The testing was in vitro (laboratory-based) with device components, not involving human data.

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

• Not applicable. Ground truth for clinical outcomes was not established as there were no clinical studies. The "ground truth" for the in vitro tests would be the accepted standards defined in the BS EN 1618-1997 specification, which are objective engineering/material performance metrics.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study was not performed. Clinical studies were not deemed necessary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No. This device is a medical catheter system, not an algorithm or AI. Standalone performance as typically described for AI/algorithm assessment is not relevant here.

7. The Type of Ground Truth Used

• The ground truth used was objective engineering and material performance standards as defined by BS EN 1618-1997. This standard likely specifies acceptable ranges or thresholds for parameters like leakage, flow rate, tensile strength, and corrosion.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" in the context of an AI or statistical model. The device development process would involve iterative design and testing, but not a formally defined "training set" as in machine learning.

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

• Not applicable. As there was no training set in the context of AI, there was no ground truth established for it. The "ground truth" for the in vitro tests was the objective performance criteria specified in the relevant engineering standard.

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The AspiraTM Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion.

The Aspira™ Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

The AspiraTM Drainage Bag is indicated for use only with the Aspira™ Drainage Catheter for intermittent drainage.

The AspiraTM Dressing Kit is indicated for dressing of a catheter and exit site.

The Aspira™ Luer Adapter is intended to provide access to the Aspira™ Drainage Catheter. It is used to drain fluid using standard wall suction, syringe or other appropriate method.

The Aspira™ Valve Assembly attaches to the Aspira™ Drainage Catheter, The Aspira™ Repair Kit is for the repair of the Aspira™ Drainage Catheter and replacement of the Aspira™ Valve.

The Aspira™ Pleural Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic pleural effusions. The primary components of the system are the AspiraTM Pleural Drainage Catheter and the Aspira™ Drainage Bag.

The Aspira™ Pleural Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The fenestrated catheter is implanted in the patient's chest cavity enabling the patient or caregiver to perform intermittent drainage of their pleural effusion at home.

The Aspira™ Drainage Bag is used to collect pleural fluid by gravity. The drainage bag attaches to the implanted catheter and is activated using an in-line silicone pump.

The AspiraTM Luer Adapter is designed to access the AspiraTM Drainage Catheter. The luer adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.

The Aspira™ Valve assembly attaches to the proximal end of the Aspira™ Pleural Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.

The Aspira™ Pleural Drainage System provides patients with a convenient method to relieve pleural effusion symptoms at home.

This is a 510(k) premarket notification for the Aspira™ Pleural Drainage System, seeking substantial equivalence to a predicate device. As such, the submission primarily focuses on comparing the new device's technological characteristics to the predicate and demonstrating that any differences do not raise new questions of safety or effectiveness and can be assessed using accepted scientific methods.

Therefore, the document does not describe an independent study to prove the device meets acceptance criteria in the way a clinical trial or performance study for a novel device would. Instead, it relies on demonstrating that the device meets established engineering and biocompatibility standards, and that its performance is equivalent to a previously cleared predicate device.

Here's an analysis of the provided text with respect to your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table with explicit "acceptance criteria" alongside specific "reported device performance" metrics as would be seen in a clinical study for diagnostic accuracy or treatment efficacy. Instead, the acceptance criteria are implicit in the adherence to various established standards, and the "reported device performance" is a general statement of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not specify a "test set" in the context of clinical data (e.g., patient cases). The "verification testing" mentioned would typically involve a predefined number of units of the device components being tested according to the referenced engineering and biocompatibility standards. For instance, for material testing, a certain number of samples are taken from a batch. For sterilization validation, an overkill method often involves a defined number of sterility tests.

• Sample size: Not specified for individual tests, but implied to be sufficient for meeting the requirements of each listed standard.
• Data provenance: Not explicitly stated, but as a submission to the US FDA by a US-based company (Bard Access Systems, Salt Lake City, Utah), the testing would typically be conducted under GLP/GCP-like conditions, likely in the US or in qualified international labs following these standards. The nature of these tests (engineering, sterilization, biocompatibility) doesn't typically involve "country of origin of data" or "retrospective/prospective" in the same way clinical patient data would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The "test set" here refers to physical components of the device and its manufacturing processes, not patient data requiring expert interpretation for ground truth. Ground truth for these types of tests is established by objective measurements against predefined engineering, chemical, and biological specifications outlined in the standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretation of clinical data. For engineering and biocompatibility testing, results are typically considered objective (e.g., pass/fail based on quantitative measurements) and do not require 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

This is not applicable. This submission concerns a physical medical device (drainage system) and not an AI or imaging diagnostic product. Therefore, no MRMC study or AI assistance evaluation was performed or required.

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

This is not applicable. This device is a physical medical device. It does not involve algorithms or AI.

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

The "ground truth" for the performance evaluation of this device is adherence to validated engineering specifications, biocompatibility requirements, and sterilization efficacy demonstrated through standardized laboratory testing. For example:

• Engineering Tests: Measurements of tensile strength, burst pressure, flow rates, luer lock integrity, radiopacity, etc., are compared against predefined limits in the respective standards.
• Biocompatibility: In vitro and in vivo tests (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) are performed, and results are compared against established biological safety criteria.
• Sterilization: Sterility assurance level (SAL) is confirmed through ethylene oxide sterilization validation, which involves biological indicators and direct product sterility testing.
• Residuals: Levels of ethylene oxide residuals are measured against pre-established permissible limits.

These are objective, quantitative measures based on scientific standards, not subjective expert interpretations of patient data.

8. The sample size for the training set

This is not applicable. This submission is for a physical medical device, not a machine learning or AI model that requires a training set.

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

This is not applicable for the same reason as point 8.

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