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The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal). The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing. There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number.

The acceptance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed in the provided text in the typical format of a device's performance metrics against predefined thresholds. This document is a 510(k) premarket notification letter, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, novel device.

However, based on the information provided, we can infer the acceptance criteria and the nature of the study conducted to demonstrate equivalence for the Terumo® Pump Tubing (68D PVC Pump Tubing) to its predicate (70D PVC Pump Tubing).

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it lists the performance evaluations conducted to demonstrate "functional equivalence" to the predicate device. The implied acceptance criterion for each test is that the 68D PVC Pump Tubing performs equivalently to or within acceptable limits of the 70D PVC Pump Tubing, without raising new issues of safety or effectiveness.

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

• Sample Size: The document does not specify the sample sizes used for each of the performance evaluations (e.g., number of tubing samples tested for durability, connection strength, etc.).
• Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation as "in-vitro performance evaluations." The country of origin of the data is implied to be within the US, where Terumo Cardiovascular Systems Corporation is located (Elkton, MD and Ashland, MA). The studies are "premarket notification" tests, which are inherently prospective for the purpose of this submission (i.e., conducted specifically to support this 510(k)).

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

This information is not applicable to this type of device and study. The testing described (e.g., dimensional analysis, connection strength, durability) relies on objective physical and chemical measurements rather than expert interpretation of complex data (like medical images). Therefore, "ground truth" in the traditional sense of expert consensus (e.g., for diagnostic accuracy) is not established.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective physical/chemical measurements, not requiring expert adjudication in the manner of medical imaging or clinical trial outcomes.

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 relevant for diagnostic or screening devices where human readers interpret patient data (e.g., images), and the AI's impact on reader performance is measured. The Terumo Pump Tubing is a component for cardiopulmonary bypass and does not involve human readers interpreting "cases."

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

Not applicable. "Standalone performance" refers to the accuracy of an AI algorithm operating independently. The Terumo Pump Tubing is a physical medical device, not an algorithm. The performance evaluations conducted are intrinsic to the device's physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (e.g., connection strength, durability, dimensions) is established by the specifications and performance characteristics of the predicate device (70D PVC Pump Tubing), as well as relevant industry standards and internal quality control specifications for medical devices of this type. The objective is to demonstrate that the new device's performance aligns with these established benchmarks, ensuring it is at least as safe and effective as the legally marketed predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning context.

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 Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.

The provided text describes a 510(k) summary for the "Pump Tubing with X-Coating" and its substantial equivalence to an uncoated pump tubing. The performance evaluation presented is primarily a comparison with the predicate device, rather than a study establishing standalone performance against specific acceptance criteria.

Here's an analysis based on your request, highlighting what is provided and what is not:

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

The document does not explicitly present quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that the performance of the Pump Tubing with X-Coating was evaluated against the uncoated pump tubing to demonstrate equivalence.

The "performance evaluations" section lists the types of tests conducted:

• Dimensional/Visual Analysis
• Leakage and Mechanical Integrity Testing
• Pull Force Testing
• 6-hour Circulation Testing
  • Flow Rate
  • Durability/Spallation
  • Thrombus Formation (Visual)
  • Effects Upon Cellular Components (Hemolysis)

The "Substantial Equivalence Comparison" and "Substantial Equivalence Summary" sections state:

• "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."
• "Any noted differences between the two devices do not raise new issues of safety and effectiveness."

Without specific numerical acceptance criteria or quantitative performance data, a direct table cannot be constructed from the provided text. The criteria are implied to be "no clinically significant differences" compared to the predicate device.

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

The document does not specify the sample sizes used for any of the performance evaluations (e.g., how many pump tubing samples were tested for durability, hemolysis, etc.). It also does not mention the data provenance beyond indicating that Terumo Cardiovascular Systems Corporation conducted the studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the submitted document. The performance evaluations described are physical and chemical tests (e.g., flow rate, durability, hemolysis, visual thrombus formation), not diagnostic or interpretative tasks requiring expert annotation for ground truth.

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

This section is not applicable for the same reasons as point 3.

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

This is not applicable. The device is pump tubing, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is pump tubing, not an AI algorithm.

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

The "ground truth" for the performance evaluations would be the results of the physical, chemical, and biological tests performed. For example:

• Dimensional/Visual Analysis: Measured dimensions and visual inspection standards.
• Leakage and Mechanical Integrity Testing: Pre-defined leakage rates or structural failure points.
• Pull Force Testing: Defined maximum or minimum pull force thresholds.
• 6-hour Circulation Testing:
  • Flow Rate: Measured flow rate compared to a control or specification.
  • Durability/Spallation: Visual inspection for material degradation, particle generation, or functional failure.
  • Thrombus Formation (Visual): Visual assessment for the presence and extent of thrombus formation against a defined scale or absence.
  • Effects Upon Cellular Components (Hemolysis): Lab measurements of hemolysis levels compared to established safety limits or predicate performance.

For the biocompatibility studies, the "ground truth" was established by adhering to ISO 10993 guidelines and conducting an in-vivo animal study, where the absence of adverse conditions reflected acceptable biocompatibility.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This is not applicable for the same reasons as point 8.

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The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.

The tubing is intended for use in procedures lasting up to 6-hours in duration.

Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Plastron Pump Tubing to its predicate device, Pexco PVC pump tubing. The provided text is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel performance metrics or conducting a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Plastron Pump Tubing were based on demonstrating equivalence to the predicate Pexco PVC pump tubing across several performance categories. The "acceptance criteria" here implicitly means that the Plastron tubing's performance in these areas should not be "clinically significantly different" from the predicate.

Summary of Performance: The document explicitly states: "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test (Dimensional Analysis, Leakage, Hemolysis, etc.). It only mentions that "The following tests were conducted to demonstrate equivalence in performance."
• Data Provenance: The origin of the data is not explicitly stated in terms of country or specific institution. Given the context of a 510(k) summary submitted to the FDA by Olson Medical Sales, Inc. (Ashland, MA), it is highly likely that the testing was conducted in the United States or by accredited laboratories adhering to US standards. The study appears to be retrospective in the sense that existing predicate device performance (which presumably has a history of safe use) is used as a benchmark for the new device. The testing of the Plastron Pump Tubing itself would have been prospective to demonstrate its equivalence.

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

This document describes an engineering and materials equivalence study, not a study requiring expert clinical interpretation to establish ground truth in the traditional sense. Therefore:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

The "ground truth" for this type of submission is largely defined by the established performance and safety record of the predicate device and the objective results from standardized engineering and biocompatibility tests.

4. Adjudication Method

Not applicable, as this was not a study requiring human interpretation or adjudication for establishing ground truth. The tests conducted are objective measurements (e.g., dimensions, flow rates, chemical residues) or standardized evaluations (e.g., hemolysis, biocompatibility per ISO 10993).

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. This submission is for medical tubing, which does not involve human interpretation in this manner.

6. Standalone Performance Study

Yes, implicitly, a standalone performance study of the Plastron Pump Tubing was performed. The "Performance Evaluations" section lists several tests (Dimensional Analysis, Leakage Testing, Hemolysis, Flow Rate, Durability, Spallation, Thrombus Formation) conducted on the Plastron Pump Tubing. The results of these tests were then compared to the performance of the predicate Pexco PVC pump tubing to establish substantial equivalence.

7. Type of Ground Truth Used

The ground truth used for this equivalence study primarily relies on:

• Predicate Device Performance: The established, legally marketed performance and safety profile of the Pexco PVC tubing serves as the primary "ground truth" for comparison.
• Engineering Standards and Specifications: Objective measurements and adherence to specified ranges (e.g., durometer Shore A-68, ID ¼" to ½").
• Biocompatibility Standards: Adherence to recognized international standards like ISO 10993 (e.g., "blood contacting materials were found to be biocompatible").
• Sterilization Standards: Validated in accordance with AAMI guidelines for SAL.
• Regulatory Limits: Compliance with FDA regulations for Ethylene Oxide residues.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device is a physical medical component, and the testing involves laboratory evaluation, not data-driven model training.

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

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

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The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Cardiopulmonary Bypass Pump Tubing

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a Cardiopulmonary Bypass Pump Tubing, detailing its classification, regulatory compliance, and indications for use. It does not include the specifics of performance testing or clinical studies.

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