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The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The provided document is a 510(k) summary for the Medtronic CardioTherm™ Blood Cardioplegia Delivery Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner one might expect for a novel diagnostic or AI-driven device.

Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission. This document details a comparison of general characteristics and nominal specifications to establish substantial equivalence.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the format of defined metrics and thresholds for a specific performance study. Instead, it presents a comparison of the Medtronic CardioTherm™ Blood Cardioplegia System's characteristics and specifications against four predicate devices to demonstrate substantial equivalence. The "performance characteristics" listed are:

The "acceptance criteria" for this type of submission are implicitly that the new device's characteristics and performance are comparable to, or within the established safety and effectiveness profile of, the predicate devices. The document argues that this is the case, stating, "The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other These predicate/marketed Blood Cardioplegia Systems currently in commercial distribution."

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 submission is a comparison of product specifications and intended use, not a clinical trial or performance study on a test set of data.

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 applicable as there is no mention of a test set requiring expert-established ground truth. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and market history.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no test set or adjudication process described.

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

This information is not applicable. The device described is a medical instrument (blood cardioplegia delivery system), not an AI-driven diagnostic tool. Therefore, there are no "human readers" or AI assistance involved in its function or evaluation in the context of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established safety and effectiveness of the predicate devices as previously cleared by regulatory bodies. The submission aims to demonstrate that the new device is "substantially equivalent" to these already-marketed devices, implying it meets similar safety and performance standards.

8. The sample size for the training set

This information is not applicable as the device is not an AI system that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

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