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The Cardica® C-Port® FlexA™ Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.

The Cardica ® C-Port ® FlexA™ Distal Anastomosis System is a sterile, single use device for creation of a compliant end-to-side anastomosis between a graft vessel and target vessel. The product consists of a delivery device that holds the graft and deploys the pre-loaded clips, and the implantable stainless steel clips. Once the graft has been loaded onto the device and the device positioned against the target vessel, the arteriotomy and anastomosis are simultaneously created by pushing the actuation button.

The provided text does not contain detailed acceptance criteria and a study specifically proving the device meets those criteria with statistical measures. Instead, it describes a Special 510(k) submission where the device is compared to a previously cleared predicate device, asserting "substantial equivalence" rather than presenting a de novo study with explicit acceptance criteria.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific bond strengths, leak rates, or success percentages with defined thresholds).
• Reported Device Performance: The document generally states: "All necessary verification testing has been performed on the C-Port ® FlexA™ Distal Anastomosis System to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device. Based on the results of risk assessment and verification/validation testing the modifications to the FlexA System raise no new safety or efficacy issues."

This implies that the implicit acceptance criteria are that the new device (Cardica C-Port FlexA™) performs functionally and safely at least as well as the predicate device (Cardica C-Port xA™), and its modifications introduce no new risks related to its intended use in creating anastomoses.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "All necessary verification testing has been performed" but does not give specific numbers of tests or samples.
• Data Provenance: Not specified. It's likely internal testing by the manufacturer (Cardica, Inc.), but the location or whether it was retrospective/prospective is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not stated. This type of device (a surgical instrument) does not typically involve human expert interpretation of data to establish ground truth in the same way an AI diagnostic device would. Performance is assessed through engineering and functional tests.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not stated. As mentioned above, ground truth for this device's performance relies on objective physical and functional testing, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI algorithms where reader performance is a key outcome. The Cardica C-Port FlexA™ is a surgical instrument.

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

• Standalone Performance: Not applicable. This is not an AI algorithm; it is a mechanical surgical device. Performance is inherent to the device's design and function, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device would be established through objective engineering and functional testing. This would include tests for:
  • Mechanical strength (e.g., clip integrity, holding power)
  • Leak integrity of the anastomosis created
  • Biocompatibility of implantable materials
  • Sterility
  • Functional operation of the delivery system (e.g., smooth deployment, proper clip formation).
    The document mentions "risk assessment and verification/validation testing," which implies these types of objective measures were used.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in that context.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set Establishment: Not applicable. As there's no machine learning, there's no training set or associated ground truth for it.

Summary of the Study (Based on the Provided Text):

The submission is a Special 510(k) for the Cardica® C-Port® FlexA™ Distal Anastomosis System. This means the device is being cleared as a modification to an already legally marketed device (the predicate: Cardica® C-Port® xA™ Distal Anastomosis System, K053524 and K063644).

The "study" involved verification testing to demonstrate that the modified device is substantially equivalent to the predicate device. The key changes were in the deployment device design to include a flexible shaft and remote graft clamp actuators. The manufacturer states that these modifications raise no new safety or efficacy issues when compared to the predicate device.

The study's conclusion is that, based on technical information, intended use, and performance information from the verification testing, the FlexA System is substantially equivalent to the predicate device for its intended use in creating anastomoses in blood vessels and grafts, including coronary artery bypass grafting procedures. No specific quantitative performance metrics from this testing are provided in the summary, relying instead on the established safety and effectiveness of the predicate device and the absence of new risks.

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