(297 days)
The Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter is intended for temporary occlusion of the coronary sinus ostium during a venogram and to serve as a conduit for access to the coronary venous system.
The VUEPORT is intended for use to access the coronary sinus and perform occlusive venograms. The catheter may serve as a conduit for the delivery and support of other devices.
The Cardima Vueport™ is a sterile, single use only, dual lumen, balloon tipped guiding catheter with various tip configurations. The Cardima Vueport™ is a "Y" connector and each branch of the "Y" houses a lumen. The smaller lumen extends from a one-way stopcock (vented and included with the Vueport), to inflate the balloon and is used for air delivery and withdrawal. The connector on a female luer is attached to the occluded lumen to perform a coronary venogram. The larger lumen is a guide to the coronary sinus vasculature for the delivery of other devices and has an open atraumatic catheter tip.
The provided text describes a medical device, the Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter, and its approval through the 510(k) pathway, which establishes substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance metrics typically seen in AI/ML device evaluations.
Therefore, the information required to populate a table of acceptance criteria and performance, as well as details about test sets, ground truth establishment, and MRMC studies, is not present in the provided document. The submission focuses on substantial equivalence based on intended use, design, and physical characteristics.
However, I can extract the information that is available:
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) submission for this device relies on demonstrating substantial equivalence to a predicate device (Electro-Catheter Corp., Elecath Occlusion Catheter (K945963) and Zeppelin Balloon Guiding Catheter (K945963)), rather than establishing specific performance acceptance criteria for a novel functionality or algorithm.
The document states:
- "Safety and effectiveness were evaluated through biocompatibility testing, reliability and mechanical testing and animal studies."
- "Mechanical properties of the catheter and found to be acceptable."
- "The Vueport™ performance was satisfactory when placed into the Coronary sinus ostium, the balloon inflated and deflated and performed acceptable venographs."
- "Cardima Vueport™ Coronary Sinus Balloon Occlusion Guiding Catheter when compared to the control catheter (i.e., Elecath) the performance was equivalent."
These statements indicate that the device met its intended function and was comparable to the predicate, but specific performance metrics (e.g., sensitivity, specificity, accuracy, or precise quantitative measures) with defined acceptance thresholds are not detailed.
2. Sample size 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 "test set" and "data provenance" concepts are typically associated with AI/ML or clinical trials. The document mentions "animal studies" without specifying the sample size or further details.
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 there is no mention of "experts" establishing a "ground truth" for a test set in the context of an AI/ML or similar evaluation. The evaluation was primarily based on mechanical functionality, biocompatibility, and animal studies, which likely involved veterinary professionals or skilled device operators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for human expert review processes, which are not described here.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is specific to evaluating AI-assisted workflows, and the Vueport™ device is a physical catheter, not an AI/ML algorithm.
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. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to performance studies aiming for objective accuracy (like for AI/ML) is not explicitly stated in the provided text. The "ground truth" for the device's acceptable performance was assessed through:
- Biocompatibility testing: Likely adherence to standards for biological safety.
- Reliability and mechanical testing: Adherence to engineering specifications.
- Animal studies: Successful occlusion of the coronary sinus ostium and performance of "acceptable venographs" (presumably evaluated by veterinarians or imaging specialists looking for clear visualization of the venous system). The "equivalence" to the control catheter in animal studies serves as the benchmark.
8. The sample size for the training set
This information is not provided. The concept of a "training set" applies to machine learning, which is not relevant for this device.
9. How the ground truth for the training set was established
This information is not provided as there is no "training set."
In summary, the provided document is a 510(k) summary for a physical medical device (catheter) demonstrating substantial equivalence. It does not contain the type of detailed performance data, acceptance criteria tables, or study designs (e.g., test set, ground truth experts, MRMC studies) typically associated with AI/ML device evaluations or detailed clinical trial reports.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).