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The Heartport® Endopulmonary Vent™ catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.

The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.

The provided text describes a 510(k) summary for the Heartport® Endopulmonary Vent™ Catheter. It discusses the device's intended use and non-clinical test results, but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the way you've outlined.

The document states that:

• "Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications."
• "The materials used in the Heartport® Endopulmonary Vent™ catheter have proven biocompatibility."

However, it does not provide details on what those "established specifications" are, what the "performance testing" entailed, or any specific numerical results. It also does not mention any clinical studies involving human readers, AI, or ground truth establishment in the context of device performance.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

Here's how I would attempt to answer based on the lack of information in the document:

Acceptance Criteria and Device Performance

Study Details (Based on available information in the document):

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "performance testing" and "biocompatibility" but does not detail sample sizes, types of data (e.g., in-vitro, ex-vivo), or provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. This document describes a non-clinical device (catheter) and discusses performance and biocompatibility testing, not an AI or diagnostic device requiring expert-established ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not specified.
4. 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 for a physical medical catheter, not an AI-assisted diagnostic or imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical catheter, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not specified. The testing described appears to be engineering performance and biocompatibility rather than diagnostic accuracy against a "ground truth" as typically defined for algorithms or diagnostic tests.
7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, non-clinical test results (performance and biocompatibility), and materials. It does not provide the detailed information about specific acceptance criteria or the methodology of performance studies (e.g., sample sizes, expert involvement, ground truth establishment) common for diagnostic devices or AI algorithms. The "performance testing" mentioned is likely in-vitro or bench testing verifying physical characteristics and functionality of the catheter, not a clinical trial involving patients and expert interpretation.

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Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.

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This document describes a medical device called the "Endopulmonary Vent," a pulmonary vent catheter intended for removing blood from the pulmonary artery and decompressing the heart during endovascular cardiopulmonary bypass. The information provided is a 510(k) summary of safety and effectiveness, meaning it's a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or detailed device performance metrics. Instead, it states:

Critique: This summary is very high-level and lacks specific quantifiable acceptance criteria (e.g., flow rate thresholds, pressure limits, material biocompatibility metrics, etc.) and corresponding measured performance values. This is typical for a 510(k) summary, which often provides an overview rather than granular test reports.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only refers to "performance testing." Given the nature of this device (a catheter), the "test set" likely refers to samples of the device itself undergoing various laboratory and perhaps animal studies.

Critique: Without this information, it's impossible to assess the statistical validity or generalizability of the testing. For a device like this, the "test set" would primarily be physical units of the device tested under simulated or in vivo conditions, not a dataset of patient images or clinical outcomes.

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

This section is not applicable to the provided document. The device is a physical catheter, not an AI or diagnostic imaging systemrequiring expert interpretation of data to establish ground truth. Ground truth for a physical device would relate to its physical and functional properties, established through engineering measurements and potentially in vivo animal studies or clinical trials with direct observation/measurement.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated in point 3.

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 AI-powered diagnostic tools or imaging systems where human readers interpret medical cases. The Endopulmonary Vent is a physical medical device.

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 is not an AI device.

7. The Type of Ground Truth Used

For a physical device like the Endopulmonary Vent, the "ground truth" for performance testing typically involves:

• Engineering Specifications: Adherence to design requirements for dimensions, material properties, tensile strength, flow rates, pressure resistance, etc.
• Biocompatibility Testing: Ensuring the materials are safe for contact with human tissue and blood (e.g., ISO 10993 standards).
• Sterility Testing: Confirming the device is sterile.
• Functional Testing: Measuring actual performance parameters in vitro (e.g., flow rates through the catheter) and potentially in vivo (e.g., animal studies to assess deployment, positioning, and effectiveness in a physiological setting).

The document broadly refers to "performance testing" but does not detail the specific types of ground truth or testing methods used.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI device that requires a training set.

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

This section is not applicable for the reasons stated in point 8.

Summary of Missing Information and Observations:

The provided text is a summary for a 510(k) submission for a physical medical device (catheter), not an AI algorithm or a diagnostic imaging system. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies) are not applicable or not detailed in this type of summary document. The document focuses on establishing substantial equivalence to predicate devices and broadly stating that performance testing confirmed safety and effectiveness. To get the specific details of performance criteria and testing, one would need to review the full 510(k) submission and associated test reports, which are usually more extensive than this public summary.

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