(30 days)
The Cardica® C-Port® Flex-A™ 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® Flex-ATM 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 document is a 510(k) summary for the Cardica® C-Port® Flex-AT™ Distal Anastomosis System. This type of submission is for device modification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria as requested. Instead, it relies on the declaration that performance data was collected and demonstrates substantial equivalence to the predicate device.
Here's a breakdown of why the requested information is absent or cannot be fully provided based solely on the given text:
1. A table of acceptance criteria and the reported device performance:
- Not present in the document. The 510(k) summary states, "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This implies that specific acceptance criteria and detailed performance results are not publicly available in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present in the document. The document mentions "All necessary in vitro and in vivo testing has been performed," but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.
3. 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/Not present. Since this is a device for creating anastomoses and not an imaging or diagnostic device requiring expert interpretation for ground truth, this information is not relevant to the type of testing described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. As mentioned above, this type of adjudication is typically for diagnostic interpretation, which is not the primary evaluation method for this device.
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:
- Not applicable/Not present. This device is an anastomosis system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not present. This device is a surgical instrument. "Standalone" performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for specific tests. For a device like this, ground truth would likely involve direct measurement of anastomotic integrity, flow, burst pressure, and histological evaluation of healing in in vivo models. However, the document only broadly states "necessary in vitro and in vivo testing."
8. The sample size for the training set:
- Not applicable/Not present. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not present. This is not an AI/machine learning device that requires a training set.
Summary of available information regarding compliance:
The 510(k) summary states that the device is substantially equivalent to the predicate device Cardica® C-Port® Flex-AT™ Distal Anastomosis System (#K070548). The basis for this equivalence is:
- Same indications for use.
- Same technological characteristics.
- Same device characteristics, method of use, materials, labeling, sterilization method, and biocompatibility.
The document explicitly states that "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This means that while internal testing was conducted to prove equivalency, the specifics of these tests, including acceptance criteria and detailed results, are not part of this public summary.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.