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The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.

The CORx IOS-200 System is a cardiopulmonary bypass system consisting of an oxygenator (870.4350), a non-roller-type cardiopulmonary bypass blood pump (870.4360), a heat exchanger (870.4240) and a blood circuit defoamer (870.4230)

Here's an analysis of the provided text regarding the acceptance criteria and study for the CardioVention CORx IOS-200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantifiable manner (e.g., "oxygen transfer rate must be at least X ml/min," or "pressure drop must not exceed Y mmHg"). Instead, it provides a general statement about performance.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "in-vitro testing." It simply states "Results of in-vitro testing."
• Data Provenance: The data is from "in-vitro testing," implying laboratory-based testing rather than clinical data from human subjects. The country of origin of the data is not specified, but the applicant (CardioVention, Inc.) is based in Santa Clara, CA, USA. The data is implicitly prospective as it was generated to support the 510(k) submission for this specific device.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method

• Adjudication Method: This information is not provided in the document. Given that the testing was "in-vitro," an adjudication method by human experts (like 2+1 or 3+1) is unlikely to be applicable in the traditional sense for establishing ground truth, unless the "in-vitro" testing involved human assessment of certain parameters that aren't fully automated. However, the document does not elaborate on this.

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

• MRMC Study Done: No. The device is a cardiopulmonary bypass system, not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC study is not applicable or mentioned.
• Effect Size of AI vs. Without AI Assistance: Not applicable. This device does not incorporate AI for interpretation or assistance in the way that diagnostic imaging devices might.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, implicitly. The "in-vitro testing" refers to the performance of the device itself (the CardioVention CORx IOS-200 System). This testing would have evaluated the device's technical specifications and functional performance in a controlled environment, essentially demonstrating its "standalone" capabilities without human interaction for its core function (extracorporeal hemodynamic and gas-exchange support). The results are summarized as "safe and effective for its intended function."

7. Type of Ground Truth Used

• Type of Ground Truth: The document does not explicitly define "ground truth" as it would for a diagnostic device. However, for a medical device like a cardiopulmonary bypass system, the "ground truth" for its performance would be established through engineering specifications, validated physical and chemical measurements (e.g., oxygen transfer, heat exchange, blood flow, pressure drop), and compliance with recognized industry standards. These are assessed via the "in-vitro testing." It is not based on expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools, but rather on direct measurements of the device's functional parameters.

8. Sample Size for the Training Set

• Training Set Sample Size: This information is not provided and is largely not applicable in the context of this traditional medical device. Training sets are primarily relevant for machine learning or AI-driven systems. This device is a mechanical and chemical system, not an algorithm that learns from data.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: This information is not provided and is not applicable for the same reasons mentioned in point 8.

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