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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 Asept Peritoneal Drainage System is indicated for periodic drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.

The Asept Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. The catheler is implanted in the patient's peritoneal cavity enabling the patient to perform periodic perioneal drainage at home or hospital. The primary components of the system are the Asept indwelling Peritoneal 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 peritoneal space until the valve is breached. The valve can be breached by the Asept Peritoneal Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Peritoneal Drainage System provides patients with a convenient way to relieve malignant ascites symploms at home.

The provided text is a 510(k) summary for the "Asept Peritoneal Drainage System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing, rather than presenting a study to prove acceptance criteria for an AI/ML powered device.

Therefore, many of the requested sections related to acceptance criteria, ground truth, expert involvement, and AI performance metrics are not applicable to this document. The device described is a physical medical device (a drainage system) and not a software algorithm that would have "acceptance criteria" in the way associated with AI/ML performance.

Here's a breakdown of what can be extracted and what is not applicable:

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

Since this is a physical device submission focused on in vitro testing to demonstrate substantial equivalence, the "acceptance criteria" are implied by the standards and the performance of the predicate device. The document states:

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

• Sample size: Not explicitly stated for each in vitro test, but implied to be sufficient for the tests mentioned by the standard BS EN 1618-1997.
• Data provenance: Not applicable. The testing was in vitro (laboratory-based) on the device itself, not on patient 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):

• Not Applicable: This pertains to clinical studies or expert review of data, neither of which were performed. The "ground truth" for in vitro testing is defined by the physical or chemical properties measured.

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

• Not Applicable: Adjudication is a process for resolving discrepancies in expert ratings or clinical outcomes, which did not occur here.

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:

• Not Applicable: This is an AI/ML specific study type, and the device is a physical drainage system.

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

• Not Applicable: This refers to AI/ML algorithm performance.

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

• In vitro measurements: The ground truth for the in vitro tests (leakage, flow rate, tensile strength, corrosion, biocompatibility) would be based on the established scientific and engineering principles, measurement instruments, and reference standards defined by the BS EN 1618-1997 and ISO 10993 standards.

8. The sample size for the training set:

• Not Applicable: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable: There is no "training set" as this is not an AI/ML device.

Summary of what the document does say about meeting criteria:

The document states, "In vitro testing was performed on the Asept Peritoneal Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion." It also mentions, "Materials used in the Asept Peritoneal Drainage System meet the requirements of ISO 10993 or Identical to legally marketed devices."

The key takeaway is that the device demonstrated safety and effectiveness through in vitro testing and comparison to legally marketed predicate devices, not through clinical trials or AI/ML performance studies.

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