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The Aspira Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

•Aspira Drainage Catheter: The Aspira Dramage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or other symptoms associated with malignant ascites.

• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for internittent 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 Aspira, 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 Peritoneal Drainage System provides patients with a convenient method to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites at home. The primary components of the Aspira Peritoneal Drainage System are the Aspira Peritoneal Drainage Catheter, the Aspira Drainage Bag, and the Aspira Drainage Bottle.

The provided text describes the 510(k) summary for the Aspira Peritoneal Drainage System. It outlines the device's intended use, indications for use, and a comparison to a predicate device. Crucially, it lists the performance data provided in support of the substantial equivalence determination, specifically focusing on bench testing and human factors engineering/user engineering.

However, the document does not provide specific acceptance criteria or detailed results in a table format. It states generally that "The results of the testing demonstrated that the subject Aspira Peritoneal Drainage System met the predetermined acceptance criteria applicable to the safety and efficacy of the device."

Furthermore, it does not include information on:

• The sample size used for the test set or data provenance.
• The number of experts used to establish ground truth or their qualifications.
• The adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Therefore, based solely on the provided text, I cannot fulfill all parts of your request. The information required for a detailed description of acceptance criteria, study design, and ground truth establishment (especially related to AI/algorithm performance) is not present. The document focuses on regulatory submission for a medical device that appears to be mechanical/physical, not an AI/software as a medical device (SaMD).

If this were an AI/SaMD, the typical information regarding "acceptance criteria" would refer to performance metrics like sensitivity, specificity, AUC, F1 score, etc., and the "study" would be a clinical validation of the algorithm. The provided text, however, refers to performance tests of a physical device.

Here's what can be extracted and inferred from the text, framed as if it were a full answer, but with caveats:

Acceptance Criteria and Study for the Aspira Peritoneal Drainage System

Based on the provided 510(k) summary for the Aspira Peritoneal Drainage System, the device's acceptance criteria and performance were assessed through a series of bench testing and human factors engineering/user engineering simulations. The document states that the testing demonstrated the device met "predetermined acceptance criteria applicable to the safety and efficacy of the device," without providing specific numerical thresholds for these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

• Note: The document lists the types of tests performed, but does not numerically define the acceptance criteria or report specific quantitative performance results for each test. The general statement is that all criteria were met.

2. Sample Size and Data Provenance for Test Set:

• The document does not specify the sample size used for the test set (e.g., number of units tested for each bench test, number of participants for human factors).
• The data provenance (e.g., country of origin, retrospective or prospective) is not stated. Given the context of a 510(k) summary, these are likely internal company tests performed to regulatory standards, rather than clinical trial data.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided. For physical device performance testing, "ground truth" might refer to engineering specifications or validated test methods, rather than expert interpretation of medical images. For human factors testing, "expert" might implicitly refer to human factors specialists and user testers, but their number and qualifications are not detailed.

4. Adjudication Method for Test Set:

• This information is not provided and is generally not applicable to bench or human factors testing of this nature. It is typically relevant for studies involving subjective interpretation (e.g., image reading).

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

• No MRMC comparative effectiveness study was mentioned. This type of study (comparing human readers with and without AI assistance) is specific to AI/SaMD and not relevant to the physical device described.

6. Standalone Algorithm Performance Study:

• No standalone algorithm performance study was mentioned. This device is not an AI/algorithm-based product.

7. Type of Ground Truth Used:

• For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and validated test methodologies. For human factors, it would be user feedback and observed performance against pre-defined usability metrics. No mention of expert consensus, pathology, or outcomes data is made for establishing ground truth in this context.

8. Sample Size for Training Set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable, as there is no training set for a physical device.

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The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symonomalic malignant asciles. The catheter is intended for long-term access of the perionely in order is intended is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage 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 vacum bottle, syringe or other suction, water drainage system, glass vacuum bottle, syringe or other appropriate method.

The Aspira® Valve Assembly altaches to the Aspira® Drainage Catheter. The Aspira® Repair of the Aspira" 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* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Aspira* Peritoneal Drainage System are the Aspira* Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira* Peritoneal Drainage System.

This document, outlining a Special 510(k) Premarket Notification for the Aspira® Peritoneal Drainage System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, a direct response to all parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided in the context of this regulatory document.

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

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

The document does not present specific quantitative "acceptance criteria" for clinical performance. Instead, it states that "Verification and validation activities were designed and performed to demonstrate that the subject Aspira® Peritoneal Drainage System met predetermined performance specifications." The general "reported device performance" is that "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."

The document lists several standards and guidance documents that were used to determine appropriate methods for evaluating the performance of the device. These indirectly form the basis of the "acceptance criteria" in a regulatory submission context, as compliance with these standards demonstrates safety and effectiveness.

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

The document does not specify a sample size for a clinical test set for the device performance. The listed "Safety & Performance Tests" are primarily related to bench testing and material evaluations (e.g., biocompatibility, sterility, packaging, Luer fittings), not clinical trials with human subjects. There is no mention of data provenance (country of origin, retrospective/prospective clinical data).

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 is not applicable to this document. The listed "tests" are primarily engineering, chemical, and biological evaluations against harmonized standards, which do not typically involve experts establishing clinical ground truth for a test set.

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

This is not applicable as there is no mention of a clinical test set requiring adjudication. The document reports on in-house engineering and laboratory testing.

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. The device is a physical medical device (peritoneal drainage system), not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are not relevant.

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

This is not applicable. The device is not an algorithm.

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

For the "tests" listed (biocompatibility, fittings, sterilization, etc.), the "ground truth" would be compliance with the specific parameters and thresholds defined within the referenced international standards (e.g., biological response within acceptable limits, fitting dimensions meeting specified tolerances, sterility assurance level achieved). These are objective measurements rather than an expert consensus on clinical findings or pathological diagnoses.

8. The sample size for the training set

This is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.

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

This is not applicable. There is no training set for this type of device.

In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a research paper detailing a study of a novel device against clinical acceptance criteria. The "proof" of meeting acceptance criteria comes from successful completion of various bench and lab tests according to recognized international standards and guidance documents, which are used to show that the device is as safe and effective as its predicate.

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The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the perioneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

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 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 Catherer. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.

The Aspira* Peritoneal Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic malignant ascites. The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the system are the Aspira* Periloncal Drainage Catheter and the Aspira* Drainage Bag.

The Aspira* Peritoneal Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the perioncal cavity to relieve symptoms associated with malignant ascites. The fenestrated catheter is placed in the patient's abdominal cavity enabling the patient or caregiver to perform intermittent drainage of their malignant ascites at home.

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

The Aspira* Luer Adapter is designed to access the Aspira* Drainage Catheter. The lucr 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* Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.

The provided document is a 510(k) premarket notification letter and summary for the Aspira Peritoneal Drainage System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for providing acceptance criteria and study results for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on the device description, its intended use and indications for use, and a technological comparison to a predicate device (PLEURX™ Peritoneal Catheter Kit and PLEURX™ Drainage Kit) to argue for substantial equivalence. It does not detail specific performance studies with quantitative acceptance criteria for the Aspira Peritoneal Drainage System itself.

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