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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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The Cardica® C-Port® xA 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 xA 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 is a 510(k) summary for the Cardica® C-Port® xA Anastomosis System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study with an AI component. Therefore, much of the requested information about AI model performance and study details is not present.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria or provide detailed performance metrics like sensitivity, specificity, accuracy, or F1-score for the device itself. Instead, the submission states that "All necessary verification testing has been performed on the C-Port xA Anastomosis System with the modified clip to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device."

The focus is on demonstrating that the modified device is as safe and effective as the predicate device (Cardica® C-Port® xA Anastomosis System, K053524). This is a common approach for 510(k) submissions where a modification to an already cleared device is being presented.

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

The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The testing mentioned is "verification testing" to assure substantial equivalence, rather than a clinical trial with a defined test set for performance.

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

This information is not applicable and therefore not present. The device is a surgical instrument (anastomosis system) and not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for a device like this would relate to its mechanical performance, biocompatibility, and ability to create a functional anastomosis, which would be assessed through engineering tests, animal studies, or potentially human clinical data (though not detailed here).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not present, as there is no diagnostic output that requires adjudication.

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

There is no mention of an MRMC study, AI, or human readers. The device is a surgical instrument.

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

This is not applicable as the device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to an AI or diagnostic device (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" would be related to its engineering specifications, successful creation of an anastomosis, and patient outcomes related to the surgical procedure, as determined through various verification and potentially pre-clinical/clinical tests. The document broadly states "All necessary verification testing has been performed," without detailing the specific "ground truth" for each test.

8. The Sample Size for the Training Set

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

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

This is not applicable for the same reason as above.

In summary, this 510(k) submission is for a modification to a mechanical surgical device and primarily focuses on demonstrating substantial equivalence to a predicate device through verification testing. It does not involve AI, image analysis, or diagnostic capabilities, and therefore, most of the requested information regarding AI model performance, expert ground truth, and study designs for such applications is absent.

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