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The Terumo® Circuit Tubing is intended to provide a conduit for extracorporeal fluid flow during cardiopulmonary bypass procedures when interconnecting components of the bypass circuit.

The tubing is intended to be used in procedures lasting not more than 6 hours.

The Terumo® Circuit Tubing is a tubing segment that provides a conduit for the flow of extracorporeal fluids within the bypass circuit. Each of the tubing segments is typically used as a conduit between other devices within the circuit. Each tubing allows for the flow of fluids created by either gravity, vacuum and pumping. The blood-contacting material is flexible polyvinyl chloride (PVC) resin.

Given the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Device: Terumo® Circuit Tubing (K150536)

Background: The document is a 510(k) premarket notification for the Terumo® Circuit Tubing, asserting its substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance evaluations conducted to demonstrate the functional equivalence of the subject device to the predicate device. These are the "acceptance criteria" in the context of demonstrating substantial equivalence.

Study Proving Acceptance Criteria:

Terumo Cardiovascular Systems conducted "in-vitro performance evaluations" to demonstrate the functional equivalence of the subject Terumo® Circuit Tubing to the predicate Terumo® Circuit Tubing. These evaluations specifically covered:

• Tubing Connection Strength
• Leakage Testing
• Dimensional Analysis
• Visual for abnormalities

Additionally, claims are made regarding sterilization and ethylene oxide residues, which would be supported by validation studies (though details are not provided in this excerpt).

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

The document does not specify the sample size used for the in-vitro performance evaluations (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective), as these were in-vitro tests, not clinical studies involving human patients. These tests would typically be conducted in a laboratory setting.

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

This information is not provided in the document. For in-vitro performance studies, "ground truth" is typically established through standardized testing methodologies and instrument readings, managed by qualified laboratory personnel, rather than expert consensus on clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not provided and is generally not applicable to the type of in-vitro physical performance testing described (e.g., for connection strength, leakage, dimensions). Adjudication methods like "2+1" are relevant for expert review of images or clinical cases, not for objective physical measurements.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical tubing for cardiopulmonary bypass; it is not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical medical component, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the in-vitro performance evaluations, the "ground truth" would be objective physical measurements and observations based on established engineering and quality control standards. For example:

• Tubing Connection Strength: Measured in units of force (e.g., Newtons) until failure, against a specified minimum.
• Leakage Testing: Observed for the presence or absence of leaks under specified pressure conditions.
• Dimensional Analysis: Measured using calibrated instruments (e.g., calipers) for inner diameter and wall thickness, compared to design specifications.
• Visual for Abnormalities: Subjective, but based on predefined criteria for acceptable appearance (e.g., no cracks, discoloration, embedded foreign particles).

8. The Sample Size for the Training Set:

This information is not provided and is not applicable in the traditional sense. This device is not an AI model that requires a "training set" of data. The "training" for such a product would involve process validation and perhaps internal design verification, but not in the machine learning context.

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

This information is not provided and is not applicable, as there is no "training set" for an AI model. For the manufacturing processes and design of the tubing, ground truth for quality establishment would be through adherence to validated manufacturing specifications, material testing standards, and quality control procedures.

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