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The PleuraFlow® System with FlowGlide® is indicated for use during cardical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

The PleuraFlow® System with FlowGlide(R) PFFG3 iss a modification to our current PleuraFlow® System with FlowGlide(R) (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube with a magnetic shuttle and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow with FlowGlide Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent. The PleuraFlow System with FlowGlide, PFFG3, has a new shuttle design that includes a spring activated button to allow the user to increase the magnetic force when needed. The range of magnetic force is the same as predicate.

This document, a 510(k) summary for the ClearFlow PleuraFlow® System with FlowGlide®, describes the device as a modification of a previously cleared device. Therefore, the information provided focuses on bench testing to demonstrate substantial equivalence to the predicate device, rather than a clinical study with human subjects.

As a result, there is no information to fulfill questions 1-9 regarding acceptance criteria and study proving device meets acceptance criteria in a clinical context, such as:

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

The document explicitly states: "No clinical performance was deemed necessary according to Risk Management assessment and evaluation." and "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device."

The acceptance criteria and "study" described are focused on engineering and functional performance bench tests to demonstrate the device performs as intended and is equivalent to the predicate.

Here's an interpretation of the "acceptance criteria" and "study" based only on the provided text, but it's important to understand this is not a clinical study:

Acceptance Criteria and Study for the ClearFlow PleuraFlow® System with FlowGlide® (Based on Bench Testing for Substantial Equivalence)

Since this is a 510(k) submission for a modified device, the "study" conducted for proving the device meets acceptance criteria is primarily bench testing to demonstrate substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

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

• Sample Size: Not specified in terms of number of units tested for each bench test, but implies a sufficient number were tested to validate the design.
• Data Provenance: The tests are described as bench testing done internally by the manufacturer (ClearFlow, Inc.) and are prospective in nature for the modified device. No external or historical data is explicitly mentioned for these specific tests.

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

• Not Applicable. This was a series of engineering and functional bench tests, not a clinical study requiring expert review of patient data to establish ground truth. The "ground truth" here is adherence to engineering specifications and performance comparable to the predicate.

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

• Not Applicable. As per point 3, this was not a clinical study involving human judgment on cases. Test results would likely be adjudicated against pre-defined engineering pass/fail criteria.

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 study is not relevant to this type of device or its premarket notification, which relies on bench testing and substantial equivalence to a predicate. There is no AI or human reader component mentioned.

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

• No. This device is a mechanical system, not an algorithm.

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

• The "ground truth" for this submission is engineering specifications, functional performance requirements, and comparison to the known performance of the predicate device. This includes passing criteria for physical and mechanical tests, and compliance with standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135:2014 for sterilization).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning or AI device. The "training" for the device would be its engineering design and manufacturing processes.

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

• Not Applicable. (As per point 8.) The design and functionality are based on established engineering principles and the existing predicate device's proven performance over "more than 10 years."

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The PleuraFlow® System with FlowGlide® XDL is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

The PleuraFlow® System with FlowGlide® XDL is an extension of the PleuraFlow® System with FlowGlide® (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The PleuraFlow System with FlowGlide XDL includes two (2) models: PFFG-20 XDL, and PFFG-24 XDL. Each model includes a Chest Tube with a cut length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each of these Chest Tubes has 15 eyelets distributed along an Effective Drainage Length of 10 inches (25.4 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. Each Chest Tube has a barium stripe to facilitate visualization in the chest cavity under X-ray. Both models include a Chest Tube with FlowGlide applied to the internal and external surfaces to reduce friction and allow easier sliding of the Clearance Wire assembly. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister. The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow Chest Tube using a magnetic shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube open.

This document describes the 510(k) premarket notification for the ClearFlow, Inc. PleuraFlow® System with FlowGlide® XDL, a device intended to proactively remove clots from chest tubes during cardiothoracic surgical procedures and chest trauma. The submission aims to demonstrate substantial equivalence to a predicate device, the PleuraFlow System with FlowGlide (K163139).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in terms of specific numerical thresholds. Instead, it describes various tests performed to demonstrate that the new models (PFFG-20 XDL and PFFG-24 XDL) are "substantially equivalent to the cleared models (predicate) through bench testing" and "suitable for the intended use." The performance is reported in a pass/fail manner, indicating that the new models met the requirements of these tests to demonstrate equivalence.

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

The document does not explicitly state the specific sample sizes for each bench test performed on the new models (PFFG-20 XDL and PFFG-24 XDL). The tests are described as "bench testing."

• Sample Size for Test Set: Not explicitly stated for the individual bench tests. It refers to "the new models PFFG-20 XDL and PFFG-24 XDL."
• Data Provenance: The data appears to be prospective as it involves new bench testing performed on the "new models" in support of the 510(k) submission. The country of origin for the data is not specified, but the applicant (ClearFlow, Inc.) is based in Anaheim, California, USA.

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

• This information is not applicable as the study described is a series of bench tests comparing a new device to a predicate, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., in medical image analysis). The "ground truth" for these engineering and performance tests would be the established specifications and performance characteristics of the predicate device and relevant industry standards.

4. Adjudication Method for the Test Set

• This information is not applicable for bench testing. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing, not on assessing human reader performance with or without AI assistance.

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

• This information is not applicable as the PleuraFlow System is a medical device (a chest tube and clearance apparatus), not an AI algorithm.

7. The Type of Ground Truth Used

• For the bench testing described, the "ground truth" is based on the established performance specifications and characteristics of the legally marketed predicate device (PleuraFlow System with FlowGlide, K163139) and relevant engineering/performance standards (e.g., for tensile strength, kink resistance, coating integrity, and simulated use). The biological risk assessment for the coating was based on ISO 10993-1 standards.

8. The Sample Size for the Training Set

• This information is not applicable as the described study involves bench testing of 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 for the same reason as above (not a machine learning model).

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The PleuraFlow® System with FlowGlide™ is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.

The PleuraFlow® System with FlowGlide™ is an extension of the PleuraFlow® System (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The PleuraFlow System with FlowGlide includes four (4) models: PFFG-20, PFFG-24, PFFG-28 and PFFG-32. Each of the four (4) models includes a Chest Tube with a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each of these chest tubes has six (6) eyelets distributed along an Effective Drainage Length of 4 inches (10.2 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. Each Chest Tube has a barium stripe to facilitate visualization in the chest cavity under X-ray. All models include a Chest Tube with FlowGlide applied to the internal and external surfaces to reduce friction and allow easier sliding of the Clearance Wire assembly. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.

The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube open.

The provided text describes a 510(k) premarket notification for the "PleuraFlow System with FlowGlide" and references a predicate device, the "PleuraFlow Catheter System (K150042)". The current submission is for an enhancement to the predicate device, specifically the addition of a "FlowGlide" coating.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it lists various bench tests performed and concludes that the device's performance was "substantially equivalent" to the predicate. The performance reported is that the modified device "is suitable for its intended use and did not raise new issues of safety and effectiveness when compared to the predicate device."

Summary of Tests Performed (as reported in the document):

Overall Conclusion: "Results from performance testing of the PleuraFlow System with FlowGlide™ demonstrate that the modified device is suitable for its intended use and did not raise new issues of safety and effectiveness when compared to the predicate device." The effectiveness of the modified device is enhanced by the FlowGlide™ coating, which provides a low friction surface.

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

The document only mentions "bench testing" and "performance testing" being conducted. It does not specify the sample sizes used for any of the individual tests. The data provenance is implied to be from internal lab studies by ClearFlow, Inc. (the applicant), as this is a premarket notification for a medical device. There is no mention of country of origin for the data or whether it was retrospective or prospective.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical outcomes or diagnostic accuracy, as the testing described is primarily bench testing related to the physical properties and functionality of the device.

4. Adjudication method for the test set

Not applicable, as the document details bench testing, not a clinical trial with human subjects requiring adjudication of outcomes or diagnoses.

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 device described, the PleuraFlow System with FlowGlide, is a physical medical device (chest tube system) for active clot clearance, not an AI or imaging-related diagnostic aid that would involve human readers or AI assistance in interpretation.

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

Not applicable, as the device is not an algorithm or AI system.

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

For the bench testing, the "ground truth" would be established by validated test methods and established engineering specifications for the physical and functional properties of the device components (e.g., specific force values for tensile strength, acceptable flow rate ranges, friction coefficients, etc.). These underlying specifications are not detailed in the provided summary.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a physical medical device, not a machine learning model.

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