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The Cardica® Cardica® C-PORT® X-CHANGE™ 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® X-CHANGE™ 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 delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and a conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis which is functionally equivalent to a hand-sutured, interrupted stitch anastomosis. The system consists of one (1) C-PORT® HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X-CHANGE™ subassemblies and one (1) Retractor Mount.

The provided text is a 510(k) summary for the Cardica® C-PORT® X-CHANGE™ Anastomosis System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance data for a new device.

Therefore, the information requested regarding acceptance criteria and a study proving a device meets them is largely not applicable in the context of this 510(k) summary. The submission's core argument is that the new device is "substantially equivalent" to an already cleared device, not that it independently meets pre-defined performance thresholds through a separate study.

However, I can extract the information that is present and explain why certain sections cannot be fully addressed based on the provided document.

Acceptance Criteria and Device Performance

Study Details (as far as can be inferred from a 510(k) summary)

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

   • Sample Size: Not specified in the summary.
   • Data Provenance: Not specified in the summary. The testing performed includes "in vitro and in vivo testing," which suggests a mix of laboratory and potentially animal or pre-clinical human studies, but details are not provided.
   • Retrospective or Prospective: Not specified.

2. 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):

   • Not Applicable. This information is typically relevant for studies involving human interpretation (e.g., imaging devices) where "ground truth" is established by expert consensus. For a mechanical medical device, ground truth is typically established through direct physical measurements, functional tests, or histological analysis, not expert interpretation of data.

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

   • Not Applicable. See point 2.

4. 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:

   • Not Applicable. This device is a surgical instrument, not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant.

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

   • Not Applicable. This device is a surgical instrument, not an algorithm. Performance would be assessed through its mechanical and functional characteristics, not algorithm-only evaluation.

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

   • For this type of device (anastomosis system), "ground truth" would likely be established through:
     • Physical measurements: verifying dimensions, clip deployment accuracy.
     • Mechanical testing: burst pressure, tensile strength of anastomoses.
     • Histological analysis: confirming vessel wall apposition and patency in animal models.
     • In vivo patency and healing studies: assessing long-term success of anastomoses in animal models.
   • The summary generically mentions "in vitro and in vivo testing," implying these types of methods were used to ensure safety, effectiveness, and substantial equivalence to the predicate.

7. The sample size for the training set:

   • Not Applicable. This information is typically relevant for machine learning or AI-based devices. For a mechanical device, there isn't a "training set" in the same sense. Design iterations and verification/validation testing are performed, but not referred to as a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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