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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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The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. 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 CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.

The provided text is a 510(k) Summary for the CardioVention PowerBase™ Console. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for AI/software devices. Therefore, much of the requested information is not explicitly available in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Results of in-vitro and software testing," but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This is common for submissions focused on substantial equivalence of hardware and software components, where bench testing and verification are emphasized over clinical trial-like data for initial market clearance.

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

This information is not provided in the document. Given the nature of the device (a cardiopulmonary bypass console) and the testing described (in-vitro and software), it's more likely that performance was verified against engineering specifications and industry standards rather than a "ground truth" established by medical experts in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI assistance. The CardioVention PowerBase™ Console is a control device, not an interpretive one.

6. Standalone Performance Study

The document states "Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function." This implies a form of standalone testing of the device's functionality and safety, but it is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of an AI algorithm's diagnostic accuracy. It refers to the device's operational performance independent of human error in its direct use.

7. Type of Ground Truth Used

The "ground truth" for this type of device would likely be based on engineering specifications, established physiological parameters for cardiopulmonary bypass, and recognized industry standards for safety and performance of such medical devices. The document does not specify "pathology" or "outcomes data" as ground truth.

8. Sample Size for the Training Set

This information is not provided. Given that this is a 510(k) for a cardiopulmonary bypass console cleared in 2003, it predates the widespread use of deep learning and large-scale AI models requiring extensive "training sets" in the modern sense. The "software testing" likely refers to traditional software verification and validation, not machine learning model training.

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

As there's no mention of a "training set" in the context of machine learning, this information is not applicable/provided. If "training set" refers to data used to develop the software, it would be internal development data validated against engineering requirements, but no details are given.

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The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. 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 CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.

The provided text describes a 510(k) premarket notification for the "CardioVention PowerBase™ Console," a cardiopulmonary bypass flow control device. However, it does not contain details about specific acceptance criteria, device performance metrics, or a formal study proving the device meets acceptance criteria in the way one would expect for an AI algorithm performance study.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through functional acceptance testing, ship testing, and software verification and validation. This is a common regulatory pathway for medical devices where the equivalence in indications for use, operational characteristics, and technological characteristics is the primary means of demonstrating safety and effectiveness.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation." However, it does not explicitly list the quantitative acceptance criteria for these tests or specific reported performance metrics beyond the intended use parameters.

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

• Sample Size for Test Set: Not specified. The testing described (functional, ship, software V&V) typically involves internal product testing rather than a "test set" of clinical cases or data in the context of an AI algorithm.
• Data Provenance: Not applicable in the context of clinical data. The performance testing is internal to the manufacturer.

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

• Number of Experts: Not applicable. The "ground truth" for a mechanical device like this is its physical and software functionality against engineering specifications, not expert consensus on medical images or diagnoses.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical and software testing typically involves direct measurement and verification against specifications, rather than adjudicating conflicting interpretations.

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

• MRMC Study Done: No. This is a device for controlling cardiopulmonary bypass flow, not an AI diagnostic or assistive imaging tool that would typically undergo an MRMC study.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in an indirect sense. The "functional acceptance testing, ship testing, and software verification and validation" represent the device's standalone performance against its specifications and intended function. There is no "human-in-the-loop" concept in the performance evaluation described for this type of device, as it is a control system.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications, functional requirements, and safety standards for cardiopulmonary bypass equipment. The device's performance is measured against these established technical benchmarks.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a traditional electro-mechanical medical device with embedded software, not a machine learning or AI-driven system that requires a "training set" of data in the common understanding. The software development process would involve various stages of testing and refinement, but not a "training set" for model learning.

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

• How Ground Truth Was Established: Not applicable, as there is no "training set" in the context of a machine learning algorithm. The software's "ground truth" is its design specifications and validated functionality.

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The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal gas exchange support. This device can be used with a legally marketed thermal requlating system. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting up to six hours.

The CORx System is intended for use with Medtronic's Bio-medicus Bio-Console.

The CardioVention CORx System is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The CardioVention CORx System consists of an active venous air removal device (defoamer), a centrifugal blood pump, a membrane oxygenator, an AirVac Controller and a pump adapter. The AirVac Controller powers the detection and facilitates removal of entrained air in the air handling system (defoamer) of the disposable unit. The pump adapter, which is magnetic, allows the use of the Medtronic Biomedicus Bio-Console (K941921) with the CORx System. The Medtronic's Biomedicus Bio-Console drives the CORx System's centrifugal pump.

The following components of the CORx System disposable are provided sterile, for single use only:

The provided document describes the CardioVention CORx System, an extracorporeal hemodynamic and gas exchange support system. The submission focuses on device performance compared to predicate devices rather than a study with a test set, ground truth, or expert involvement typical of AI/ML device evaluations. Therefore, many of the requested categories are not applicable.

Here's the information that could be extracted and a note for non-applicable sections:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "the CORx System" and "the predicate devices" in a general sense for testing, implying a certain number of units were tested but not providing specific counts.
• Data Provenance: The tests appear to be laboratory-based physical characterization and performance testing of the device itself, comparing it to predicate devices. The country of origin and whether it was retrospective or prospective is not specified, but it would typically be prospective testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a medical device performance submission based on physical and functional testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth on a patient dataset.

4. Adjudication method for the test set:

• Not Applicable. As above, no expert adjudication was involved in this type of device performance testing.

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. This is not an AI-assisted diagnostic device, so no MRMC study involving human readers or AI assistance was conducted.

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

• Not Applicable. This is a hardware medical device with mechanical and fluidic functions, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by the specifications and performance of the legally marketed predicate devices, against which the CORx System was compared for substantial equivalence. For instance, the "ground truth" for oxygen transfer is the performance profile of the Optimin Hollow Fiber Oxygenator.

8. The sample size for the training set:

• Not Applicable. This is a hardware medical device, not an AI/ML system that requires a traditional training set.

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

• Not Applicable. As above.

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