(141 days)
The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.
The subject device is substantially equivalent in intended use, technological characteristics, and materials to currently marketed Heartport arterial kits.
This document is a 510(k) summary for a medical device submitted to the FDA in 1999. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a more modern AI/ML device submission.
Therefore, many of the requested sections below either cannot be answered or can only be addressed by stating that the information is not provided in this context.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device meets established specifications. | "Performance testing demonstrated that the subject device meets established specifications." |
| Substantially equivalent in intended use. | "The subject device is substantially equivalent in intended use... to currently marketed Heartport arterial kits." |
| Substantially equivalent in technological characteristics. | "The subject device is substantially equivalent in... technological characteristics... to currently marketed Heartport arterial kits." |
| Substantially equivalent in materials. | "The subject device is substantially equivalent in... materials to currently marketed Heartport arterial kits." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical test results" and "performance testing" but does not detail the sample size or data provenance for these tests. Given the nature of a 1999 510(k) for a physical medical device (cannulae), the "testing" likely involved engineering and biocompatibility tests rather than clinical data sets as would be relevant for AI/ML.
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 information is not provided. As this is a physical medical device from 1999, the concept of "ground truth" derived from expert consensus on a test set (like for an imaging AI) is not applicable here. The "ground truth" for this device would be its ability to physically perform its function (e.g., deliver blood, allow introduction/removal of catheters) as per engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for human-led assessments of complex data, which isn't the focus of this device's submission.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-driven clinical decision support tools or imaging analysis, which this device (surgical cannulae) is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical surgical tool and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" would be related to its physical and functional performance according to engineering and biocompatibility standards. For example, testing for tensile strength, flow rates, biocompatibility, and ability to house the designated catheter. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.
8. The sample size for the training set
This information is not provided. This concept of a "training set" is not applicable to the development and testing of this physical medical device.
9. How the ground truth for the training set was established
This information is not provided. Similarly, the concept of a "training set" and associated ground truth is not applicable here.
§ 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).