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The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.

This is a 510(k) premarket notification for a medical device called the "Jostra Mecc System". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the requested information about acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, ground truth, and training set information is not applicable to this 510(k) submission.

Here's why and what can be inferred from the document:

• Acceptance Criteria and Reported Device Performance: In a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. There isn't a table of specific performance metrics against pre-defined acceptance thresholds as you'd find in a clinical trial for a new therapeutic or diagnostic device. The document states: "The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use."

• Study That Proves the Device Meets Acceptance Criteria: The "study" here is a comparison to a predicate device, not a typical clinical trial. The document explicitly states: "All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit." This implies bench testing and possibly animal studies pertinent to the predicate device's clearance, but no specific study details are provided for the Jostra Mecc System in this summary.

• Sample Size for Test Set and Data Provenance: Not applicable. The submission relies on equivalence.

• Number of Experts and Qualifications: Not applicable. Ground truth establishment by experts is not described for this type of submission.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic performance, often with human readers. This device is an extracorporeal circuit.

• Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device, not an AI/algorithm-based diagnostic tool.

• Type of Ground Truth Used: Not applicable in the context of demonstrating performance against a ground truth. The "ground truth" for a 510(k) of this nature is that the predicate device is safe and effective when used as intended.

• Sample Size for the Training Set: Not applicable. This is not a machine learning device.

• How the Ground Truth for the Training Set Was Established: Not applicable.

Summary of Relevant Information from the Document:

While the direct answers to your questions are "not applicable" due to the nature of a 510(k) submission for this device, here's what the document does provide:

1. Predicate Device: Bentley Duraflo Treated Extracorporeal Circuit
2. Comparison Basis: The Jostra Mecc System provides the same components as the Bentley Duraflo system, assembled to the manufacturer's specifications. All components of both systems have previous 510(k) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit.
3. Intended Use: For use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
4. Conclusion: The FDA determined that the Jostra Mecc System is substantially equivalent to the predicate devices.

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