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

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

• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent drainage.

· Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.

· Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.

• Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with silicone catheters with inner diameters between 0.103" - 0.116 such as the Aspira, Asept®, PleurX® and Rocket® catheters.

• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.

· Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method.

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

The document focuses on the Aspira Pleural Drainage System and its substantial equivalence to a predicate device. It extensively lists performance data based on various international and ASTM standards. However, it does not describe a study involving an AI component, human readers, or clinical performance metrics in the way your request specifies. The provided text details device performance testing for safety and functionality, not an evaluation of an AI algorithm's diagnostic accuracy.

Therefore, many of the requested categories about AI performance and associated study details cannot be extracted from this document, as they are not present.

Here's a breakdown of the available information based on your request, highlighting what is present and what is missing due to the nature of the document:

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

The document lists numerous performance data points, but it doesn't explicitly present them in a "table of acceptance criteria and reported device performance" format. Instead, it lists the various tests conducted and generally states that the device "met the predetermined acceptance criteria." The specific quantitative acceptance criteria and detailed performance results for each test are not provided in this summary.

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

This information is not explicitly provided in the context of an AI model's test set. The document describes several bench and human factors engineering tests for the physical device, but it doesn't detail the "sample size" for these tests in a way that would be relevant to an AI performance study (e.g., number of images, patients). Data provenance for these engineering tests is not specified in terms of country of origin or retrospective/prospective.

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 and is not present. This document describes the clearance of a physical medical device, not an AI algorithm requiring expert ground truth for a test set. The human factors engineering study likely involved a group of users, but their qualifications are not detailed as "experts" establishing "ground truth" for diagnostic purposes.

4. Adjudication method for the test set

This information is not applicable and is not present. This document does not describe an AI diagnostic test set or an adjudication process for such.

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 such study is mentioned or implied. This document is for the clearance of a long-term intermittent pleural drainage system, not an AI-assisted diagnostic tool.

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

This information is not applicable and is not present. There is no AI algorithm being evaluated in this document.

7. The type of ground truth used

This information is not applicable and is not present in the context of diagnostic ground truth. The "ground truth" in this document relates to the physical and functional performance of the device against engineering standards (e.g., a leak test either passes or fails).

8. The sample size for the training set

This information is not applicable and is not present. There is no AI algorithm and therefore no training set mentioned.

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

This information is not applicable and is not present. There is no AI algorithm and therefore no training set mentioned.

Summary of available information related to performance criteria for the physical device:

The document lists various performance tests conducted for the Aspira Pleural Drainage System, based on national and international standards. These tests cover:

• Labeling: Conformance to ISO 15223-1:2016 for medical device symbols.
• Sterility: Conformance to ASTM F2250-13:2018, ASTM F2252/F2252M-13:2018, ISO 11135:2014, AAMI TIR28:2016, ISO 14644-1:2015, ISO 14644-2:2015, ISO 11737-1:2018, and ISO 10993-7:2008.
• Biological Safety (Biocompatibility): Conformance to ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2015, ISO 10993-10:2014, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-18:2020, ISO 10993-19:2020, ISO 10993-23:2021, and ASTM F2475-11:2020. It states that all patient-contacting portions are identical to the predicate device, and the Aspira Drainage Bottle is non-patient contacting, thus no additional biocompatibility testing was required for it.
• Device/Design: Conformance to ISO 594-1:1986, ISO 594-2:1998, ISO 80369-7:2017, ISO 20697:2018, ISO 10079-3:2014, and ASTM F640:20.
  • Specific bench tests for the Aspira Valve included: Catheter Leak Test (Negative Pressure), Tensile Strength (Valve Assembly to Catheter), and Design Validation (Insertion Forces) for compatibility with Aspira, Asept®, PleurX®, and Rocket® catheters.
  • Specific bench tests for the Aspira Drainage Bottle included: Component Deformation Under Vacuum, Tensile Barb to Tubing, Tensile Tubing to Connector, Tensile Tubing, Impact Resistance, Suction Source Impact Resistance, Leak Test, 1000 mL Fluid Pull, 1000 mL Fluid Pull Rate, and Tensile Valve to Tubing.
• Human Factors Engineering/User Engineering Simulated Use: This involved evaluating user interaction with the device focusing on:
  • Vacuum Loss
  • Fluid Leak
  • Drainage Speed Control
  • Bottle Emptying
  • Bottle Activation Force
  • Bottle Activation Method
  • Drainage Time
  • Indication of Full Flow
  • Intuitiveness of Status
  • Handle Reseal Ability
  • Grip Comfort when Empty
  • Grip Comfort when Full
  • IFU Understandability for Lay Users
  • Ease of Use
• Packaging: Conformance to ISO 11607-1:2019, ISO 11607-2:2019, ISO 2233:2001, ASTM D4169-16, ASTM F2096-11, ASTM F1929-15, ASTM F88/F88M-15, and ASTM F1980-16. Specific tests included Visual Inspection and Seal Strength/Burst Testing.
• Quality: Conformance to ISO 14971:2019, IEC 62366-1:2015, and ISO 13485:2016.

Conclusion based on the document:

The manufacturer concluded that "The results of the testing demonstrated that the subject Aspira Pleural Drainage System met the predetermined acceptance criteria applicable to the safety and efficacy of the device." This statement, along with the detailed list of performed tests and compliance with relevant standards, constitutes the proof that the device meets its acceptance criteria for safety and effectiveness as a physical medical device. The FDA's clearance (K212696) confirms their agreement with this assessment for substantial equivalence to the predicate device.

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

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

The Aspira* Luer/Universal Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, 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 Assembly.

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

This document describes the Aspira Pleural Drainage System*, a medical device designed for long-term intermittent drainage of pleural fluid. The submission is a Special 510(k) Premarket Notification (K110409) dated February 9, 2011, by Bard Access Systems, Inc. The purpose of this notification is to demonstrate the substantial equivalence of the modified device to a previously cleared predicate device (K071095).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the verification and validation activities conducted to demonstrate that the Aspira* Pleural Drainage System met predetermined performance specifications. The acceptance criteria are implicitly defined by the adherence to a set of recognized international standards and internal protocols. The "reported device performance" is a general statement that the device met all pre-determined acceptance criteria.

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

The provided document does not specify the sample sizes used for the test set for any of the mentioned verification and validation activities. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective) as the studies are entirely non-clinical (engineering and biocompatibility testing).

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

This information is not applicable to this type of submission. The studies described are primarily engineering and biocompatibility tests, not clinical studies requiring expert consensus for ground truth. The "ground truth" for these tests would be the compliance with the specified international standards and internal performance specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or evaluators, which is not the case for the verification and validation activities described here. Compliance is determined against pre-defined engineering and biological criteria.

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

There was no MRMC comparative effectiveness study done. This device is a physical medical device (drainage system), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This is not applicable as the device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for these studies is:

• Compliance with established international standards: Such as ISO 10993, ISO 594, EN 1617, EN 1618, ISO 11607, ISTA -1G, BS EN 550, ISO 11135, and AAMI TIR 19.
• Adherence to in-house protocols and predetermined performance specifications: These would cover aspects like device functionality, integrity, and safety.
• Substantial equivalence to a predicate device (K071095): The ultimate ground truth is demonstrating that the modified device is as safe and effective as the previously cleared predicate device, based on the non-clinical tests.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/machine learning system that requires a "training set." The studies performed are for validating the physical properties and performance of a medical device.

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

This information is not applicable as there is no training set for this type of medical device submission.

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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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