(170 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria are not detailed in the provided document. The document generally states that the device must meet "established specifications" for performance and biocompatibility. | The Heartport® Endopulmonary Vent™ catheter "meets established specifications" for performance. The materials used "have proven biocompatibility." No specific numerical performance metrics are provided. |
Study Details (Based on available information in the document):
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not specified.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
- 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.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).