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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 Rocket IPC Platinum Cured Catheter is intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice.

The Rocket IPC Platinum Cured Catheter is a fenestrated silicone drainage catheter indicated for intermittent, long-term drainage of symptomatic, recurrent, effusion or ascites, including malignant effusion or ascites and other recurrent effusions or ascites that do not respond to medical management of underlying disease. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the body. The Rocket platinum Cured Catheter is used alongside the Rocket IPC drainage line and Rocket IPC bottles (these we included in the Rocket Indwelling Pleural Catheter (IPC) System (K123033) & Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K152105).

The provided document is a 510(k) Premarket Notification for the Rocket Platinum Cured Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests, primarily bench testing. It does not describe a study involving an AI/machine learning device; therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, expert consensus for ground truth, training set information) are not applicable.

Below is a summary based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them for this specific type of medical device (a physical catheter).

The Rocket Platinum Cured Catheter underwent a series of non-clinical performance tests to demonstrate its safety and effectiveness and its substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes "Table 9.1: Summary of Verification Testing" which details specific acceptance criteria and the results.

Additional performance data in "Table 9.2: Summary of Further Testing Performed" (Biocompatibility tests):

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

• Sample Size for Bench Testing: For the tests listed in Table 9.1, the sample size used was 3 units for each specific test (e.g., Resistance to deformation, Force at break, Freedom from leakage).
• Data Provenance: The tests are non-clinical bench tests performed on the device itself.
  • Country of Origin: The submitter is Rocket Medical Plc., located in Washington, Tyne & Wear, United Kingdom. The tests would likely have been conducted in the UK or by a contracted lab.
  • Retrospective or Prospective: These are prospective laboratory performance tests designed to evaluate the physical and biological characteristics of the device.

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

This question is largely not applicable as the studies are focused on physical and biological performance of the catheter, not diagnostic image analysis or clinical decision support where expert medical interpretation forms ground truth. The "ground truth" for these tests is established by objective physical measurements (e.g., force, leakage, flow rate, chemical composition) and standardized biological assay results against predefined specifications in recognized international standards (e.g., ISO, EN, ASTM). The "experts" involved would be qualified laboratory technicians and scientists following validated test protocols.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML device relying on human consensus for ground truth. These are objective engineering and biocompatibility tests. Results are determined by direct measurement against quantitative or qualitative pass/fail criteria from international standards.

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

No, a MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI/ML devices where human readers (e.g., radiologists) interpret cases with or without AI assistance. The Rocket Platinum Cured Catheter is a physical medical device (catheter) for drainage, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• International Standards: Compliance with recognized international standards (e.g., ISO 10993 series for biocompatibility, EN 1617/1618 for catheters).
• Objective Bench Test Measurements: Quantifiable physical properties (e.g., force, pressure, flow rate, deformation) measured in controlled laboratory settings.
• Biocompatibility Assay Results: Biological responses (e.g., cytotoxicity, sensitization, pyrogenicity, toxicity, irritation) observed in standardized in vitro and in vivo models.
• Predetermined Specifications: The device's performance is measured against internal design specifications and requirements derived from the relevant standards, ensuring Pass or Fail.

8. The Sample Size for the Training Set

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

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

Not applicable. As a physical device, there is no AI/ML training set or associated ground truth to establish.

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The Passio Pump Drainage System is 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 dyspnes and chest discomfort associated with malignant pleural effusion and other recurrent effusions.

Not Found

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided text is an FDA 510(k) clearance letter for the "Passio Pump Drainage System." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It details the device's indications for use (intermittent drainage of recurrent and symptomatic pleural effusions) and regulatory information.

However, it does not include any details on:

• Acceptance criteria: There's no table or description of specific performance thresholds for the device.
• Device performance data: No study results, metrics (e.g., accuracy, sensitivity, specificity, flow rate, pressure, durability), or reported performance numbers are present.
• Study design details: There's no information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as that information is not in the provided text.

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The Passio Pump 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.

Not Found

The provided text is an FDA 510(k) clearance letter for the Passio Pump Drainage System. It grants clearance for a medical device used for draining pleural effusions.

Crucially, this document is a regulatory clearance letter and does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical study report or a pre-market submission summary for AI/ML-based devices.

The letter confirms substantial equivalence to a predicate device and discusses regulatory requirements, but it does not detail:

• Performance metrics (e.g., sensitivity, specificity, accuracy, precision).
• Sample sizes for test or training sets.
• Data provenance.
• Expert qualifications or adjudication methods for ground truth establishment.
• Multi-reader multi-case studies or standalone algorithm performance.
• The type of ground truth used.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. This device is a physical pump drainage system, not an AI/ML-based diagnostic or assistive software, which is typically where the types of acceptance criteria and study designs you've listed would be relevant.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report for an AI/ML-driven medical device, not a 510(k) clearance letter for a mechanical device.

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The Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (Model # R51400-16-PL and R51400-MI-PL) 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 underlying disease.

The device is indicated for:

• The palliation of dyspnea due to pleural effusion
• Providing pleurodesis (resolution of the pleural effusion)

This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

Model R51400-16-PL IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, it contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2). Model R51400-MI-PL is the Mini Kit with fewer accessories and no drugs. It is for use by surgeons where the patients are already draped and insertion components are readily available. The Rocket IPC Insertion Kits are provided sterile and are for single use only.
The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone catheter, with a barium sulfate stripe through its length, intended for the drainage of pleural effusion. 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 pleural space. This valve can only be operated with the specifically designed drainage line and drainage bottles supplied by Rocket Medical.

The provided text is a 510(k) Summary for a medical device (Rocket Indwelling Pleural Catheter (IPC) Insertion Kit). It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a new clinical study to prove the device meets specific acceptance criteria in the manner one would for a novel AI/software medical device.

Therefore, many of the typical bullet points for AI/software device evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, ground truth establishment for AI models) are not applicable to this document, as it outlines a comparison to a predicate device based on existing performance data and technical specifications.

However, I can extract the closest information analogous to "acceptance criteria" and "device performance" in the context of this 510(k) submission, which revolves around demonstrating that the new device is as safe and effective as the predicate.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):

The "acceptance criteria" here are implicitly that the subject device's performance characteristics match or are demonstrably equivalent to those of the predicate device. The "reported device performance" is not from new testing of the subject device (for most aspects), but rather a statement that its performance is identical to the predicate due to identical components and principles.

Regarding the study that proves the device meets acceptance criteria (interpreted as proof of substantial equivalence):

1. Sample size used for the test set and the data provenance:

   • This is not a "test set" in the machine learning sense. The "study" for substantial equivalence relies on existing data and specifications of the predicate device (K123033) and a reference predicate (K162457).
   • No new clinical data or specific sample sizes are mentioned for demonstrating the subject device's performance (outside of the pre-existing data for the predicate).
   • Provenance: The predicate device (K123033) and reference predicate (K162457) are also from Rocket Medical PLC, GB. The general context of 510(k) submissions relies on historical data and verified performance of existing devices. The terms "retrospective" or "prospective" are not applicable here, as it's a comparison to established devices.

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

   • Not applicable. This is not a study requiring expert ground truth for a test set. The "truth" is established by the prior FDA clearances of the predicate devices.

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

   • Not applicable.

4. 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 a physical medical device, not an AI/software device involving human readers.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for proving substantial equivalence relies on pre-existing regulatory clearances, performance data, and technical specifications of the predicate device(s). For the added components (Lidocaine HCl, USP and DuraPrep), their "ground truth" for safety and efficacy comes from their individual clearances and conformance to USP monographs and manufacturer validations (e.g., for EtO sterilization).

7. The sample size for the training set:

   • Not applicable. This refers to AI/ML model training, which is not relevant here.

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

   • Not applicable. This refers to AI/ML model training, which is not relevant here.

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The Pleural Catheter Kits are 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 1) the palliation of dyspnea effusion and 2) providing pleurodesis (resolution of the pleural effusion). The Pleural Catheter Kits are indicated for adults only.

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 Valve Kit is intended to repair the Pleur X Catheter and replace the PleurX Valve. The PleurX Valve Kit is indicated for adults only.

The Pleur X 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 effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX Low Profile Catheter is indicated for adults only.

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

The CareFusion Pleurx Pleural Catheter System, cleared under K160450, is a medical device for draining symptomatic, recurrent pleural effusion. The provided text indicates this 510(k) submission is for a change in material formulation and concentration, and minor design modifications to the devices previously cleared under K141965. No clinical studies were conducted for this submission. The device's acceptance criteria and performance are based on a series of non-clinical, in-vitro performance tests and biocompatibility studies.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data. The performance was evaluated through non-clinical laboratory testing against recognized standards. The provenance of the data is from these laboratory tests, which are typically conducted in a controlled environment, not on human subjects or patient data.

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 as no clinical tests were conducted and thus no expert-established ground truth from a test set in a clinical context. The "ground truth" for non-clinical tests is established by adherence to the specified standards and the objective measurement of device performance against the requirements of those standards.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used requiring 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. The Pleurx Pleural Catheter System is a physical medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way typically associated with MRMC studies.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the device's performance is based on the objective measurements and pass/fail criteria defined by the internationally recognized standards (e.g., ISO, AAMI, ASTM, EN) listed in the "Performance Test Summary" section. For example, biocompatibility is evaluated against the requirements of ISO 10993 standards, and physical performance against specific EN standards.

8. The sample size for the training set:

Not applicable, as no clinical or AI-based training set was used. The submission is about modifications to an existing device and relies on non-clinical testing.

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

Not applicable, as no training set was used.

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The Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, mcluding malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids

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

The provided text describes a 510(k) premarket notification for the Pleurx Pleural Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study where the device performance is measured against specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from this document. The submission relies on non-clinical (bench) testing to support its claims of substantial equivalence for a labeling update.

Here's what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance:

This 510(k) submission updates previously cleared device labeling to include the use of sclerosing agents (Talc and Bleomycin) with the Pleurx Pleural Catheter System. The acceptance criteria for this specific submission relate to the validation of this change through biocompatibility and bench testing. The "performance data" section lists standards and tests conducted, implying that the device "passed" or met the requirements of these standards. However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided for the device's clinical function in this document.

For example, for Biocompatibility, the acceptance criterion would be "meets ISO 10993-1, -3, -4, -5, -6, -10, -11 requirements" and the reported device performance is "passed" or "met." The specific metrics and thresholds for each test are not detailed in this summary.

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

• Test set sample size: Not specified. The document refers to "non-clinical tests," which likely involve a number of samples for each bench test conducted according to the standards.
• Data provenance: Non-clinical (bench) testing data. The country of origin is not specified, but the standards cited are international (ISO, EN, ASTM, AAMI).

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

Not applicable. Given this is a non-clinical (bench) testing submission, expert opinion for establishing a "ground truth" in the clinical sense is not relevant. The "ground truth" for these tests would be the established pass/fail criteria within the cited international standards by which the device was evaluated.

4. Adjudication method for the test set:

Not applicable. This type of adjudication is typically for clinical studies where subjective assessments might be involved. For bench testing, the results are typically objective measurements against a standard.

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/software device and no MRMC study was conducted. The document explicitly states: "N/A – No clinical tests were conducted for this submission."

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the specific test method and acceptance criteria outlined in the cited international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for ethylene oxide sterilization).

8. The sample size for the training set:

Not applicable. This is not an AI/software device, so there is no training set in that context.

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

Not applicable, for the same reason as above.

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The Rocket IPC Insertion Kit and the Rocket IPC Dressing Pack and Bottle Set are 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 underlying disease. This device should only be used by or under the supervision of trained personnel and in conjunction with current clinical practice guidelines.

The devices are indicated for:

1. The palliation of dyspnea due to pleural effusion
2. Providing pleurodesis (resolution of the pleural effusion).

The Rocket IPC Bottle Sets are indicated for use only with the Rocket Indwelling Pleural Catheter for intermittent drainage. The Rocket Dressing Packs are indicated for dressing of a catheter and exit site.

The Rocket Indwelling Pleural Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of pleural effusions. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent collected air and fluid from migrating back into the pleural cavity. The IPC System will consist of the IPC and components necessary for its' use such as convenience kits to aid in the implantation of the Rocket IPC.

The Rocket IPC System, a fenestrated silicone drainage catheter for pleural effusions, underwent performance testing in accordance with applicable FDA Guidance documents and ISO standards. The device demonstrated satisfactory performance against predefined acceptance criteria for various physical and functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

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

For the performance tests listed in the table, a sample size of 3 devices was used for each test. The document does not specify the country of origin of the data or whether the study was retrospective or prospective, as these were bench tests performed on the device itself.

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

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved objective bench testing against measurable physical and functional criteria, not an adjudication process by human experts.

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

An MRMC comparative effectiveness study was not conducted. The document describes bench testing for device performance and a comparison of technological characteristics to a predicate device, but not a study involving human readers with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

This information is not applicable as the device is a physical medical device (catheter system), not an algorithm or AI system. The performance tests focused on the device's physical and functional properties.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests was established by objective, measurable criteria defined in referenced international and national standards (e.g., EN 1617:1997, EN 1618:1997, ASTM F1980). These standards define the acceptable performance limits for the device's physical and functional characteristics.

8. Sample Size for the Training Set:

This information is not applicable as the submission describes a physical medical device and its bench testing, not an AI or algorithm-based device that would require a training set.

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

This information is not applicable for the reasons stated above.

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The Pleurx Pleural Catheter Kits are 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 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 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 pleural space.

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

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

The provided document describes the 510(k) submission for the CareFusion Pleurx Pleural Catheter System. This submission focuses on expanding the indications for use and adding accessories to an existing legally marketed device. Therefore, the information provided primarily concerns non-clinical testing for substantial equivalence, rather than a clinical study evaluating the device's performance against specific acceptance criteria for efficacy or accuracy in the way an AI/ML device would be assessed.

Here's a breakdown of the requested information based on the provided text, with notes where the information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with various recognized standards for medical device safety and performance, and the "reported device performance" is the conclusion that the device meets or exceeds these standards, demonstrating substantial equivalence to predicate devices. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, or accuracy) reported that would be typical for an AI/ML device.

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

This information is N/A. The document states, "N/A - No clinical tests were conducted for this submission." The testing described is non-clinical (biocompatibility, performance characteristics like sterilization, packaging integrity, etc.) and refers to compliance with standards rather than a test set of patient data.

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

This information is N/A as no clinical test set requiring expert ground truth was conducted.

4. Adjudication Method for the Test Set

This information is N/A as no clinical test set requiring adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

This information is N/A. This is not an AI/ML device, and no MRMC study was conducted.

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

This information is N/A. This is not an AI/ML device.

7. The Type of Ground Truth Used

This information is N/A as no clinical ground truth was established for this submission. The "ground truth" for this submission is adherence to recognized non-clinical performance standards and substantial equivalence to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is N/A. This is not an AI/ML device, and therefore no training set was used.

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

This information is N/A. This is not an AI/ML device, and therefore no training set or its associated ground truth was established.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" is a series of non-clinical bench tests and evaluations demonstrating compliance with a comprehensive list of national and international standards related to biocompatibility, sterilization, packaging, and general catheter performance. The submission concludes that these non-clinical tests collectively show the CareFusion Pleurx Pleural Catheter System meets or exceeds all performance requirements and is substantially equivalent to existing predicate devices. No clinical studies were conducted for this specific 510(k) submission, as it focused on expanding indications and adding accessories to an already legally marketed device by demonstrating equivalence to previously cleared devices and adherence to established non-clinical performance and safety standards.

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The Pleurx Pleural Catheter Kits are 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 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).

The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx 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 Dressing Kits are indicated for dressing of a catheter and exit site.

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pleurx Pleural Catheter System:

The provided document is a 510(k) summary for the Pleurx Pleural Catheter System, primarily focusing on establishing substantial equivalence to predicate devices. As such, it details non-clinical tests rather than clinical studies with human participants. Therefore, many of the requested points related to clinical studies, ground truth establishment, expert adjudication, and human reader performance will not be applicable.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not describe a test set in the context of a clinical study or a dataset for an AI/algorithm. The tests listed are non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests on the device itself.
   • Data provenance: Not applicable in the context of clinical data. The tests are laboratory-based, not using patient data from specific countries.

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

   • Not applicable. No "ground truth" in the sense of clinical diagnoses or interpretations by experts was established for these non-clinical engineering and material tests. The "ground truth" for these tests would be the specifications and requirements defined by the referenced standards.

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

   • Not applicable. There was no adjudication process described for clinical interpretations or diagnoses.

4. 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 MRMC study was done. This device is a physical medical device (catheter system), not an AI/software device that assists human readers.

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

   • No standalone algorithm performance study was done. This is a physical medical device.

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

   • For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced ISO, EN, and ASTM standards (e.g., specific thresholds for chemical residuals, packaging integrity, material properties, sterilization efficacy). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

   • Not applicable. As there is no training set for an AI model, this question does not apply.

Summary of the Study:

The document describes a submission for a Pleurx Pleural Catheter System, which is a physical medical device. The "study" referenced in the acceptance criteria section consists of a series of non-clinical performance, biocompatibility, and sterilization validation tests. These tests were conducted against established international and national standards (ISO, EN, ANSI/AAMI, ASTM). The purpose of these tests was to demonstrate that the new device meets the necessary safety and performance requirements and is substantially equivalent to existing predicate devices. No clinical studies or studies involving human data, AI algorithms, or expert interpretations were conducted or reported for this 510(k) submission. The conclusion explicitly states: "N/A - No clinical tests were conducted for this submission."

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