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The Cardica® C-Port® XATM PLUS™ 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® xATM PLUSTM Distal Anastomosis System is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in the conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device and the device positioned against the target vessel, the anastomosis is created by pushing the actuation button.

The provided text describes a 510(k) submission for the C-Port® xA PLUS™ Distal Anastomosis System, which is a sterile, single-use device intended for creating end-to-side anastomoses between a conduit and a small vessel, specifically for coronary artery bypass grafting procedures.

It's important to note that this document is a 510(k) Summary for a Special 510(k) for Device Modification. This means the device is being compared to a previously cleared predicate device (Cardica® C-Port® xA™ Distal Anastomosis System, K063644). The clearance is based on demonstrating "substantial equivalence" rather than a full, de novo clinical trial proving effectiveness against specific acceptance criteria in the same way a PMA device might. Therefore, the information regarding specific acceptance criteria and detailed study outcomes will be limited compared to a novel device submission.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., performance metrics with numerical thresholds) or reported device performance against those criteria for this specific modified device in a clinical setting.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (K063644). The "acceptance criteria" are implied to be that the modified device's performance, as demonstrated through various testing, is not significantly different from, and is as safe and effective as, the legally marketed predicate device.

The study that proves the device meets the acceptance criteria (of substantial equivalence) is described as:

• Device Testing Results and Conclusion: "All necessary in vitro and in vivo testing has been performed on the C-Port® XATM PLUS™ Distal Anastomosis System to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

Without access to the full 510(k) submission, the specifics of these in vitro and in vivo tests and their individual results against defined performance parameters are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The summary states "All necessary in vitro and in vivo testing has been performed." However, it does not provide details on the sample size for any test sets (neither for in vitro nor in vivo studies). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of any animal or human data if such was collected beyond basic engineering tests). Given it's a Special 510(k) for modification and not a de novo clearance, extensive human clinical data might not have been required or provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary. Since the submission relies on demonstrating substantial equivalence through in vitro and in vivo testing (likely mechanical, functional, and possibly animal studies), the concept of "experts establishing ground truth" in the context of clinical accuracy or diagnosis (e.g., for AI/imaging devices) does not directly apply here. The "ground truth" would be established by the performance metrics of the tests themselves (e.g., burst pressure, clip retention, patency in animal models).

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus among experts is needed (e.g., radiologists reviewing images). This device is a surgical instrument, and its performance would be assessed through objective measurements from engineering tests or animal studies, not human adjudication of subjective data.

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 MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for diagnostic devices, particularly AI-powered image analysis tools, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a surgical instrument, not a diagnostic or AI-assisted diagnostic tool.

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

Not Applicable/Not done. This device is a mechanical surgical instrument. The concept of "standalone algorithm performance" without human-in-the-loop is specific to AI/software devices and does not apply to the C-Port® xA PLUS™ Distal Anastomosis System.

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

For the in vitro and in vivo testing mentioned, the "ground truth" would likely be derived from:

• Physical and mechanical measurements: For in vitro tests (e.g., clip retention strength, burst pressure of an anastomosis, leakage rates).
• Physiological and anatomical observations: For in vivo animal studies (e.g., patency of anastomosis, histological assessment of tissue healing, absence of foreign body reaction, functional outcomes).

The summary does not specify the exact types of ground truth used for each test.

8. The sample size for the training set

Not Applicable/Not provided. This device is a mechanical surgical instrument and does not involve AI or machine learning, therefore, there is no "training set."

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

Not Applicable/Not provided. As there is no training set for an AI/ML model, this question does not apply.

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