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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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