(71 days)
The Endoarterial Return Cannula with and without a hemostasis valve is , indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.
This document describes the premarket notification for the Heartport™ Endoarterial Return™ Cannula. The information provided is for a medical device and, as such, the concept of "acceptance criteria" and "device performance" as might be found in a software AI/ML context is not directly applicable in the same way. Instead, for a medical device submitted for 510(k) clearance, the primary "acceptance criterion" is substantial equivalence to a predicate device, demonstrated through performance testing against established specifications.
Here's an analysis based on the provided text, reformulating the AI/ML-centric questions for a medical device context:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a cannula, "acceptance criteria" relate to engineering specifications and performance characteristics, rather than diagnostic accuracy metrics. The document only provides a high-level statement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Established specifications (e.g., fluid flow, pressure tolerance, material strength, biocompatibility) | "Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications." |
| Biocompatibility | "The materials used in the Heartport Endoarterial Return Cannula have proven biocompatibility." |
| Intended Use | "Substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified. Performance testing for medical devices often involves a series of physical tests with multiple samples, but the exact numbers are not detailed in this summary.
- Data provenance: Not specified. These would typically be internal laboratory tests conducted by the manufacturer (Heartport, Inc., USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable to a non-AI medical device like a cannula. "Ground truth" in this context would be defined by engineering standards and validated test methods, not expert medical opinion on diagnostic images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Device performance testing is based on objective measurements and established protocols, not expert 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
Not applicable. This is not an AI/ML device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" would be established by:
- Engineering specifications and standards: These define what constitutes acceptable material properties, dimensions, fluid dynamics, and mechanical integrity for a cardiovascular cannula.
- Biocompatibility testing standards: These define methods and criteria for assessing the device's interaction with biological systems.
- Clinical experience with predicate devices: The "substantial equivalence" claim implies that the established safety and effectiveness profile of the predicate devices serves as a benchmark.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI/ML training set.
Summary of the Study (as presented in the 510(k) summary):
The provided document is a 510(k) summary for the Heartport™ Endoarterial Return™ Cannula. The "study" referenced is the collection of non-clinical performance testing and biocompatibility testing conducted by Heartport, Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices (Heartport™ Endoarterial Return™ Cannula and BioMedicus® Cannula).
The key findings reported are:
- "Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications."
- "The materials used...have proven biocompatibility."
The FDA's letter (K971291) confirms that based on this information, the device was found substantially equivalent to predicate devices. This means it met the regulatory acceptance criteria for market clearance, rather than specific performance metrics against an AI model's "ground truth."
§ 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).