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The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.

The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.

The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.

Based on the provided text, the device in question is the ASEPT® Peritoneal Drainage System, which is a medical device and not an AI or imaging diagnostic tool. Therefore, the questions related to AI performance, ground truth establishment for AI training/testing, expert adjudication, and MRMC studies are not applicable to this submission.

The document describes the acceptance criteria and study for demonstrating substantial equivalence of a medical device, primarily through bench testing and a clinical literature review, not through AI performance metrics or clinical trials with human subjects for efficacy.

Here's a breakdown of the information that can be extracted from the provided text, addressing the relevant parts of your request:

Acceptance Criteria and Device Performance:

Since this is a 510(k) submission for a non-AI medical device (a catheter system), the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, focusing on functional performance, materials, and safety, primarily through bench testing. Clinical efficacy is supported by existing literature rather than a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Bench testing was performed on the ASEPT® Peritoneal Catheter and replacement valve to demonstrate substantial equivalence." The performance testing requirements were determined by the predicate and reference devices and assessment of risk. However, the specific quantitative acceptance criteria and the detailed reported numerical performance data from these bench tests are not provided in this summary.

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

• Test Set (Bench Testing): The specific sample sizes for the bench tests are not mentioned in the document.
• Data Provenance (Clinical Literature Review): The clinical literature review "demonstrates that peritoneal drainage catheters have a history of safety and efficacy in non-malignant refractory ascites and that the incidence of device related complications is more closely related to patient specific health status and preferences than the underlying cause (malignant vs non-malignant) of ascites." The provenance of this literature (e.g., countries of origin, retrospective/prospective nature of studies reviewed) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. As this is not an AI/imaging diagnostic device requiring expert interpretation for ground truth, this question is not relevant. The substantial equivalence is based on engineering design, materials, and a review of existing clinical literature.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no "adjudication method" in the context of human expert review of AI output or images for this type of device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for imaging diagnostic devices assessing reader performance with and without AI. This device is a peritoneal drainage system. The document explicitly states: "No clinical tests were conducted for this submission."

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

• Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

• For Bench Testing: The "ground truth" for bench testing would be established by the engineering specifications and performance standards determined from the predicate and reference devices.
• For Clinical Support: The "ground truth" for clinical support is derived from a clinical literature review summarizing existing evidence on the safety and efficacy of peritoneal drainage catheters in general, as well as specific data related to the predicate device. This literature effectively serves as the "outcomes data" or "expert consensus" from prior studies.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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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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