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The ASEPT Glide 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 Glide 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 trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

The ASEPT Glide 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 Glide 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. The device is provided sterile.

The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.

The provided text is a 510(k) summary for the ASEPT® Glide Peritoneal Drainage System, a medical device for draining ascites. It focuses on demonstrating substantial equivalence to a predicate device through bench testing and technical comparisons.

Crucially, this document does not describe a study involving an AI/software device that generates performance metrics (like accuracy, sensitivity, specificity) against acceptance criteria established with expert consensus or ground truth.

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and performance data for an AI/software device. The document explicitly states:

• "No clinical tests were required to confirm the safety and effectiveness of the subject device." (Page 7, Section IX)
• The performance data section (Page 7, Section VIII) refers to "Bench testing" for the catheter and valve, and "Biocompatibility" and "sterilization process" validation, not AI model performance.

The device is a physical medical device (Peritoneal Drainage System), not an AI/software as a medical device (SaMD).

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The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ 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 intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.

For Peritoneal Use: The PleurX™ LP Catheter Mini Kit 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 PleurX™ Low Profile 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 PleurX™ Low Profile Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.

For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.

For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.

The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.

The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).

The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.

The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.

The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.

The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.

The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).

This document is a 510(k) summary for the PeritX™ Peritoneal Catheter System. It describes a medical device, which is a peritoneal dialysis system and accessories. This is a Class II device. The document states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the performance tests conducted. Instead, it lists the types of non-clinical tests performed to evaluate "technological characteristics and performance criteria". The conclusion states that the device's performance is "comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device."

Table of Acceptance Criteria and Reported Device Performance:

The study primarily focuses on demonstrating equivalence through various engineering and functional tests rather than clinical efficacy, given it's a 510(k) submission for a device system with a new accessory.

Details of the Study:

• 1. Table of Acceptance Criteria and the Reported Device Performance:
  As noted above, specific quantitative acceptance criteria are not presented in the provided text. The reported device performance is a general statement of comparability and equivalent safety and effectiveness to the predicate device.

• 2. Sample Size Used for the Test Set and Data Provenance:
  The document lists various non-clinical tests (e.g., Visual Inspection, Tensile Strength, Volume Capacity, Drop Test, Resistance to Leakage). However, it does not specify the sample size used for any of these tests. The data provenance is implied to be from internal testing conducted by Bard Peripheral Vascular, Inc. within the USA. The data is non-clinical, likely from laboratory testing.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
  This information is not provided in the document, as the testing described is non-clinical (engineering and functional tests), not involving expert-established ground truth in the typical clinical sense.

• 4. Adjudication Method for the Test Set:
  This information is not provided as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical studies.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
  No MRMC comparative effectiveness study was done. The document focuses on non-clinical performance testing for substantial equivalence.

• 6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
  This question is not applicable as the device is a physical medical device (catheter system and accessories), not a software algorithm with standalone performance metrics.

• 7. Type of Ground Truth Used:
  The "ground truth" for the non-clinical tests performed would be defined by engineering specifications, material properties, and functional requirements. For example, a tensile strength test would have a specified minimum strength that the device must meet. This is derived from design requirements and industry standards, not from expert consensus, pathology, or outcomes data in the clinical sense.

• 8. Sample Size for the Training Set:
  This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."

• 9. How the Ground Truth for the Training Set Was Established:
  This information is not applicable for the same reason as point 8.

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The Passio Pump Drainage System 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 relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies involving AI or ground truth. The document is an FDA 510(k) clearance letter for the "Passio Pump Drainage System," which is a medical device for draining malignant ascites, not an AI or software-based device. It confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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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 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 PleurX Peritoneal Catheter 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 PleurX 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 PleurX Peritoneal Catheter is indicated for adults only.

The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve ascites symptoms. The primary components of the PleurX Peritoneal Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.

The provided text primarily details a 510(k) premarket notification for the "PleurX Peritoneal Catheter System" and clarifies its indications for use, rather than presenting a study with specific acceptance criteria and performance data in a quantitative manner. The document asserts that the device is substantially equivalent to a legally marketed predicate device (CareFusion PleurX Peritoneal Catheter System: K160437).

However, I can extract the following information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and states that "Bench-level testing was carried out... to demonstrate substantial equivalence."

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

• Sample Size: Not specified for any bench-level or clinical literature review.
• Data Provenance:
  • Bench-level testing: Conducted by the manufacturer (CareFusion).
  • Clinical information: Derived from a "clinical literature review." Details on the scope (e.g., country of origin, retrospective/prospective nature of the studies reviewed) are not provided in this excerpt.

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

This information is not provided. The document primarily refers to bench testing and a literature review, not a test set requiring expert ground truth establishment in the typical sense of a diagnostic or AI study.

4. Adjudication Method for the Test Set:

Not applicable, as no described test set with expert ground truth establishment is present in the provided text.

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

No, an MRMC comparative effectiveness study is not mentioned as having been conducted. The submission relies on non-clinical testing and a clinical literature review to support substantial equivalence.

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

Not applicable. The device is a physical medical device (catheter system), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• For non-clinical testing: Performance against established engineering and design specifications for medical devices, inferred from "predicate devices and leak testing."
• For clinical information: The "clinical literature review" served as the basis for understanding safety and efficacy, implying published clinical data from existing studies constituted the "ground truth" for the claims made regarding the device's performance in managing ascites.

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/algorithm-based device requiring a training set.

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

Not applicable.

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The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic. recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

This document is a 510(k) premarket notification for the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a Class II medical device used for intermittent drainage and palliation of symptoms related to recurrent malignant ascites. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit; K152105).

The table provided details the "Substantial Equivalence" comparison between the subject device and its predicate. This section outlines various parameters where the subject device is deemed equivalent to the predicate, with a specific focus on performance, biocompatibility, packaging, sterility, sterilization method, and shelf life.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of strict numerical thresholds or target metrics for the device's clinical performance (e.g., success rates in draining ascites, complication rates). Instead, the "Performance" section within the "Substantial Equivalence" table describes the types of tests conducted to demonstrate equivalence to the predicate. Therefore, the "acceptance criteria" are implied to be meeting the established safety and performance characteristics of the predicate device as evaluated through the specified tests. The "reported device performance" is that the subject device performs similarly to the predicate under these tests.

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

The document describes performance testing (resistance to deformation, force at break, freedom from leakage) and biocompatibility testing. However, it does not specify the sample sizes used for these tests. The data provenance is implied to be from Rocket Medical Plc. (UK manufacturer). Given the context of a 510(k) submission primarily comparing the subject device to a predicate, these tests would typically be prospective experimental studies performed on samples of the subject device. The document does not mention any clinical studies using human patients for the direct evaluation of this specific device's general performance.

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

This document describes a 510(k) substantial equivalence submission, which relies heavily on laboratory-based performance testing and adherence to recognized standards (e.g., for biocompatibility). It does not mention the use of experts to establish "ground truth" in the context of clinical interpretation or diagnostic accuracy, as might be seen for an AI or imaging device. The "ground truth" for the performance tests would be defined by the measurement instruments and protocols used in the laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" here refers to physical performance and biocompatibility tests, not clinical data requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic data (e.g., imaging devices with AI assistance) to assess the impact of the device on reader performance. The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device for draining fluids, not a diagnostic tool requiring human interpretation for its primary function.

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

No, a standalone performance evaluation (in the context of an algorithm or AI) was not done. This device is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used

For mechanical performance and material properties, the "ground truth" is established by objective measurements against defined engineering specifications and international standards (e.g., ISO standards for breaking force, leakage).
For biocompatibility, the "ground truth" is established by validated laboratory assays (e.g., cytotoxicity tests, sensitization tests) according to recognized standards like ISO 10993.
For sterility, the "ground truth" is established by specific sterility testing methods to confirm a Sterility Assurance Level (SAL) of 10⁻⁶.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

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The PleurX Peritoneal Catheter System is indicated for intermittent. Iong term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the Pleur X Valve.
The Pleur X LP Catheter Mini Kit is intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.

The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the PleurX Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.

The provided document describes a 510(k) premarket notification for the PleurX Peritoneal Catheter System. This submission is for modifications to an existing device, not a new AI-powered diagnostic system. Therefore, the questions related to AI-specific performance metrics (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable.

The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests and the standards they adhere to. It does not provide specific numerical acceptance criteria or reported device performance values in a table format. Instead, it indicates that testing was conducted according to these standards to demonstrate substantial equivalence.

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

This is not an AI/software device. The "test set" here refers to the samples used in bench testing. The document does not specify the sample sizes for each bench test conducted. The data provenance is from "bench-level testing" and is therefore not country-specific or retrospective/prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical device, not an AI diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and the functionality of the device as measured by standard laboratory equipment and methodologies.

4. Adjudication method for the test set

Not applicable. The performance testing involves objective measurements against established engineering and biocompatibility standards, not subjective expert 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

Not applicable. This is not an AI device, so no MRMC study was conducted related to AI assistance.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated through bench testing.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established engineering standards for medical devices, material science properties, biocompatibility assays, and sterilization effectiveness.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" for an algorithm.

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

Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning.

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The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

The provided text describes the Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. It is a 510(k) premarket notification for a Class II medical device used for intermittent drainage of symptomatic, recurrent malignant ascites and palliation of related symptoms.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Beyond these specific tests, the document also mentions compliance with numerous ISO and EN standards related to biocompatibility, sterilization, packaging, and quality management systems (Sections 9.1 and 9.2). The overall conclusion is that "the Rocket IPC design met all specifications and is adequate for its intended use" (Section 10.1).

2. Sample Size used for the test set and the data provenance:

• Sample Size: For the specific performance tests listed in the table, the sample size used was 3 for each test.
• Data Provenance: The document does not explicitly state the country of origin for the test data, but the applicant's address is United Kingdom (Washington, Tyne and Wear, NE38 9BZ, United Kingdom). It does not specify if the testing was retrospective or prospective, but bench testing on new devices is typically considered prospective for that specific testing, even if the overall design builds on existing knowledge.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The tests performed are engineering/performance bench tests against established standards, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication method for the test set:

• This information is not applicable as the tests are objective material/performance characteristic evaluations, not assessments requiring human adjudication of subjective data.

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, an MRMC comparative effectiveness study was not done. This document describes the regulatory submission for a physical medical device (catheter kit) and its performance characteristics, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical catheter kit for drainage, not an algorithm.

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

• The "ground truth" for the performance tests was defined by the acceptance criteria of the referenced ISO and EN standards. These standards stipulate objective physical and functional requirements (e.g., minimum force at break, no leakage, no significant deformation). In essence, the standard is the ground truth for these engineering tests.

8. The sample size for the training set:

• This information is not applicable as this is a physical medical device, not a machine learning model that requires a "training set."

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

• This information is not applicable as this is a physical medical device.

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The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.

The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.

The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.

The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.

The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.

The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.

The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.

The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Periloneal Catheter and the Pleurx Drainage Kits.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pleurx Peritoneal Catheter System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria with quantitative thresholds alongside reported device performance results in the way commonly seen for AI/ML devices or diagnostic tools. Instead, it lists the types of non-clinical tests performed and states that the device "meets or exceeds all performance requirements."

However, we can infer the "acceptance criteria" were implied by the referenced standards, and the "reported device performance" is a general statement of compliance.

2. Sample Size and Data Provenance

The document explicitly states: "N/A - No clinical tests were conducted for this submission".
Therefore, there is no information on:

• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Sample size for the training set.

3. Number of Experts and Qualifications

Since no clinical studies were performed, there is no mention of experts used to establish ground truth. The device's performance was evaluated through non-clinical, bench-level testing against established standards.

4. Adjudication Method

Not applicable, as no clinical studies with expert review were conducted.

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

Not applicable. No clinical studies were performed, and this device is a physical medical device (catheter system), not an AI/ML diagnostic tool typically assessed with MRMC studies.

6. Standalone Performance

The device's performance was evaluated in a standalone manner through "bench-level testing" and compliance with referenced standards. The statement "The results of the non-clinical tests show that the CareFusion Pleurx Peritoneal Catheter System meets or exceed all performance requirements" indicates standalone assessment against predefined engineering and material standards. This is not a "standalone algorithm performance" in the context of AI, but rather standalone physical device performance.

7. Type of Ground Truth

The "ground truth" for this device's evaluation was based on:

• Engineering and Material Standards: The various ISO, EN, ANSI/AAMI, and ASTM standards listed (e.g., ISO 10993 for biocompatibility, EN 1617 for drainage catheters, ASTM F1980 for aging).
• Predicate Device Characteristics: The existing predicate devices (e.g., CareFusion Pleurx Catheter Systems: K113854) set the benchmark for technological characteristics.

8. Sample Size for the Training Set

No information is provided, as no clinical studies or machine learning algorithms were involved that would require a "training set."

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

Not applicable, as no training set was used for this type of device submission.

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