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The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.

This is a 510(k) summary for the SMARxT Tubing and Connectors, a medical device used in cardiopulmonary bypass. The document states that the modified device, which uses a different surface treatment material (Tegomer additive material is changing from Tegomer H-Si6441 P), is substantially equivalent to its predicate device. This determination is based on non-clinical testing.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for each of the in vitro tests. It only states that "in vitro testing was performed."
• Data Provenance: The data provenance is retrospective in the sense that it's a submission for regulatory clearance based on testing already completed. The tests were performed by Livanova USA Inc., presumably in a controlled laboratory environment. The country of origin of the data is not explicitly stated but can be inferred to be from the manufacturer's testing facilities, likely in the US or Europe given Livanova's global presence.

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

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications, not human expert interpretation of data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications. There was no need for human adjudication of test results in the way it might apply to image-based diagnostic AI.

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 conducted. This device is hardware (tubing and connectors) and does not involve AI or human readers for its function.

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

No, a standalone (algorithm only) performance study was not conducted. This device is hardware and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its substantial equivalence determination, was established through adherence to recognized medical device standards and rigorous in vitro performance testing. This includes:

• International Standard ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
• FDA Guidance Document: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process of September 4, 2020."
• Internal performance specifications/requirements: The specific acceptance criteria for "Blood pathway integrity and coverage," "Surface Modification Integrity," "Connection testing," "Life to failure testing," and "Spallation" would have been defined by the manufacturer based on the predicate device's performance and clinical requirements for cardiopulmonary bypass tubing.

Essentially, the ground truth is that the device must perform equivalently to its predicate and meet established safety and performance benchmarks for its intended use.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware and does not involve machine learning or an AI algorithm, therefore, there is no "training set."

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

Not Applicable. As there is no training set.

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COBE® SMAR T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.

COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance thresholds in a clinical or analytical setting. Instead, it describes a 510(k) submission for a medical device (COBE® SMARxT™ Tubing and Connectors) and outlines the testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance values against those criteria. It lists the types of performance tests conducted but does not specify the pass/fail thresholds or the measured outcomes.

• Bond Strength
• Static Leak Test
• Rated Pressure
• Kink Resistance
• Tubing Pump Life
• Tubing Spallation
• Saturation/Hematocrit Connector Testing

In-vitro testing was performed to demonstrate:

• Improved blood compatibility of the materials containing the surface modifying additive. |

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

The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The tests described appear to be in vitro and potentially laboratory-based rather than clinical studies with human subjects.

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 not provided. The testing described is technical performance and biocompatibility testing of a medical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are objective engineering and material property assessments, not subjective assessments requiring 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

This is not applicable. The device is tubing and connectors for cardiopulmonary bypass circuits, not an AI-assisted diagnostic or decision-support system.

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

This is not applicable. The device is a physical medical component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the established engineering specifications and material properties for similar medical-grade tubing and connectors, along with standards for biocompatibility. For example:

• Bond Strength: Meeting a minimum force required to separate bonded components.
• Static Leak Test: No leakage observed under a specified pressure.
• Rated Pressure: Withstanding a maximum specified pressure without failure.
• Kink Resistance: Maintaining patency under specified bending conditions.
• Tubing Pump Life: Enduring a minimum number of pump cycles without failure or significant degradation.
• Tubing Spallation: Exhibiting an acceptable level of particulate generation during pumping.
• Biocompatibility: Meeting ISO 10993 standards and showing no adverse biological reactions in vitro.

The predicate device (COBE® Tubing and Connectors) likely served as the benchmark against which the new device demonstrated "substantial equivalence."

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable.

Summary of the Study:

The study performed was a series of in-vitro performance and biocompatibility tests designed to demonstrate that the COBE® SMARxT™ Tubing and Connectors are substantially equivalent to the legally marketed predicate device (COBE® Tubing and Connectors). The primary difference in the new device is the addition of a non-leaching, surface-modifying additive to improve blood compatibility. The tests aimed to prove that this additive does not negatively impact the safety and effectiveness of the device's core mechanical and fluid-handling functions, and in fact, provides an improved characteristic (blood compatibility). The specific quantitative results and acceptance criteria for these tests are not provided in the summary.

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