Search Results

Chase Medical multiple perfusion sets are intended for use in conjunction with cardiopulmonary bypass surgery for simultaneous perfusion of the aortic root and 3 or 4 vein grafts.

During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The multiple perfusion set allows the simultaneous perfusion of cardioplegia into the aortic root and vein grafts.

This 510K summary for the Chase Medical Multiple Perfusion Set does not contain the level of detail requested for acceptance criteria and study information. It focuses on demonstrating substantial equivalence to a predicate device and basic functional testing, rather than an in-depth clinical or performance study with detailed acceptance criteria and ground truth analysis.

Here's a breakdown of the available information and where details are missing:

1. A table of acceptance criteria and the reported device performance

Missing Information/Cannot Determine From Provided Text:

The provided text focuses on the device's physical and functional properties, primarily through comparison to a predicate device and basic engineering tests. It does not describe studies related to AI algorithms, clinical diagnosis, or human reader performance. Therefore, the following sections cannot be answered based on the provided document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • No test sets for diagnostic performance are described. The "test sets" for physical properties are implied by the testing listed (e.g., specific devices tested for leaks, bond strength, etc.), but sample sizes are not given.
• 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)
  • Not applicable as there is no diagnostic or interpretive element to this device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable.
• 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 device is a medical perfusion set, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • For the physical tests, the "ground truth" is adherence to established engineering standards (e.g., 10 psi, 10 lb tensile strength, ANSI/HIMA MD70.1-1983). For substantial equivalence, the predicate device's characteristics serve as the benchmark.
• 8. The sample size for the training set
  • Not applicable. No training set for an algorithm is mentioned.
• 9. How the ground truth for the training set was established
  • Not applicable.

In summary, this 510K document describes a medical device for cardiopulmonary bypass surgery. Its "acceptance criteria" are primarily related to its physical and functional performance, demonstrating substantial equivalence to a predicate device, and adherence to material and sterilization standards. It does not involve any AI algorithms, diagnostic claims, or studies requiring human reader evaluation or clinical ground truth as typically understood in the context of AI regulatory submissions.

Ask a specific question about this device